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Details for Generic Name: gemcitabine hydrochloride

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Gemcitabine hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Actavis Totowa, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Hameln Rds Gmbh, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Luitpold, Onco Therapies Ltd, Sagent Pharms, Sun Pharma Global, Teva Pharms, and Lilly, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for gemcitabine hydrochloride. Two suppliers are listed for this compound.

Summary for Generic Name: gemcitabine hydrochloride

Tradenames:2
Patents:0
Applicants:17
NDAs:19
Drug Master File Entries: see list27
Suppliers: see list2

Pharmacology for Ingredient: gemcitabine hydrochloride

Clinical Trials for: gemcitabine hydrochloride

Gamma-Secretase Inhibitor RO4929097 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors
Status: Completed Condition: Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine
Status: Terminated Condition: Meningitis; Neoplasms

ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors
Status: Active, not recruiting Condition: Adult Solid Neoplasm; BRCA1 Mutation Carrier; BRCA2 Mutation Carrier

Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer
Status: Completed Condition: Ovarian Cancer; Primary Peritoneal Cancer

PP-Gemcitabine & External Beam Radiation-Sarcomas
Status: Active, not recruiting Condition: Sarcoma

Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas
Status: Recruiting Condition: Lymphoma

Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Status: Recruiting Condition: BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Pancreatic Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
Status: Active, not recruiting Condition: Cholangiocarcinoma of the Gallbladder; Localized Gallbladder Cancer; Unresectable Gallbladder Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer
Status: Not yet recruiting Condition: Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
Status: Recruiting Condition: Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Digestive System Diseases; Endocrine System Diseases; Gemcitabine; Antimetabolites, Antineoplastic

Gemcitabine Hydrochloride With or Without Pazopanib Hydrochloride in Treating Patients With Refractory Soft Tissue Sarcoma
Status: Recruiting Condition: Adult Alveolar Soft-part Sarcoma; Adult Angiosarcoma; Adult Desmoplastic Small Round Cell Tumor; Adult Epithelioid Hemangioendothelioma; Adult Epithelioid Sarcoma; Adult Extraskeletal Chondrosarcoma; Adult Extraskeletal Osteosarcoma; Adult Fibrosarcoma; Adult Leiomyosarcoma; Adult Liposarcoma; Adult Malignant Fibrous Histiocytoma; Adult Malignant Hemangiopericytoma; Adult Malignant Mesenchymoma; Adult Neurofibrosarcoma; Adult Rhabdomyosarcoma; Adult Synovial Sarcoma; Childhood Alveolar Soft-part Sarcoma; Childhood Angiosarcoma; Childhood Desmoplastic Small Round Cell Tumor; Childhood Epithelioid Hemangioendothelioma; Childhood Epithelioid Sarcoma; Childhood Fibrosarcoma; Childhood Leiomyosarcoma; Childhood Liposarcoma; Childhood Malignant Hemangiopericytoma; Childhood Malignant Mesenchymoma; Childhood Neurofibrosarcoma; Childhood Synovial Sarcoma; Dermatofibrosarcoma Protuberans; Metastatic Childhood Soft Tissue Sarcoma; Nonmetastatic Childhood Soft Tissue Sarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Childhood Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma

Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
Status: Recruiting Condition: Duct Cell Adenocarcinoma of the Pancreas; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Tanespimycin, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors
Status: Completed Condition: Unspecified Adult Solid Tumor, Protocol Specific

p53MVA Vaccine and Gemcitabine Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer
Status: Not yet recruiting Condition: Recurrent Ovarian Epithelial Cancer

Selinexor, Gemcitabine Hydrochloride, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Pancreatic Cancer
Status: Not yet recruiting Condition: Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Stage IV Pancreatic Cancer

Gemcitabine Pharmacokinetics After Preoperative Chemoradiation Therapy
Status: Recruiting Condition: Pancreatic Cancer

ADH-1, Gemcitabine Hydrochloride and Cisplatin in Treating Patients With Metastatic Pancreatic or Biliary Tract Cancer That Cannot Be Removed By Surgery
Status: Recruiting Condition: Acinar Cell Adenocarcinoma of the Pancreas; Adenocarcinoma of the Gallbladder; Adult Primary Cholangiocellular Carcinoma; Advanced Adult Primary Liver Cancer; Cholangiocarcinoma of the Gallbladder; Duct Cell Adenocarcinoma of the Pancreas; Localized Unresectable Adult Primary Liver Cancer; Periampullary Adenocarcinoma; Recurrent Adult Primary Liver Cancer; Recurrent Gallbladder Cancer; Recurrent Pancreatic Cancer; Stage II Gallbladder Cancer; Stage III Pancreatic Cancer; Stage IIIA Gallbladder Cancer; Stage IIIB Gallbladder Cancer; Stage IV Pancreatic Cancer; Stage IVA Gallbladder Cancer; Stage IVB Gallbladder Cancer

GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
Status: Completed Condition: Unspecified Adult Solid Tumor, Protocol Specific

Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
Status: Active, not recruiting Condition: Leydig Cell Tumor; Ovarian Sarcoma; Ovarian Stromal Cancer; Pseudomyxoma Peritonei; Recurrent Cervical Cancer; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Primary Peritoneal Cavity Cancer; Recurrent Uterine Sarcoma; Recurrent Vaginal Cancer; Recurrent Vulvar Cancer

Calcitriol, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
Status: Recruiting Condition: Unspecified Adult Solid Tumor, Protocol Specific

Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors
Status: Not yet recruiting Condition: Recurrent Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors
Status: Active, not recruiting Condition: Solid Tumor; Urethral Cancer

HAI Abraxane With Gemcitabine and Bevacizumab
Status: Completed Condition: Advanced Cancers

A Study Comparing AZD-1775 (MK-1775) and Gemcitabine With Gemcitabine Alone in Ovarian, Peritoneal or Fallopian Tube Cancers
Status: Not yet recruiting Condition: Epithelial Ovarian Carcinoma; Primary Peritoneal Carcinoma; Fallopian Tube Carcinoma; Platinum-resistant; Platinum-refractory

Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer
Status: Terminated Condition: Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter; Regional Transitional Cell Cancer of the Renal Pelvis and Ureter; Stage III Bladder Cancer; Stage III Pancreatic Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Bladder Cancer; Stage IV Non-small Cell Lung Cancer; Stage IV Pancreatic Cancer; Transitional Cell Carcinoma of the Bladder; Unresectable Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer

Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma
Status: Recruiting Condition: Advanced Malignant Pleural Mesothelioma

Dovitinib Lactate, Gemcitabine Hydrochloride, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Solid Tumors or Pancreatic Cancer
Status: Not yet recruiting Condition: Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma
Status: Recruiting Condition: Recurrent Adult Hodgkin Lymphoma; Refractory Childhood Hodgkin Lymphoma

Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed by Surgery
Status: Recruiting Condition: Pancreatic Acinar Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer
Status: Active, not recruiting Condition: Metastatic Breast Cancer

Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer
Status: Active, not recruiting Condition: Metastatic Pancreatic Adenocarcinoma

Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer
Status: Completed Condition: Metastatic Pancreatic Cancer

Dovitinib Lactate, Gemcitabine Hydrochloride, and Capecitabine in Treating Patients With Advanced or Metastatic Solid Tumors, Pancreatic Cancer and Biliary Cancers
Status: Active, not recruiting Condition: Adenocarcinoma of the Pancreas; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Bortezomib and Gemcitabine in Treating Older Patients With Advanced Solid Tumors
Status: Completed Condition: Breast Cancer; Colorectal Cancer; Head and Neck Cancer; Kidney Cancer; Lung Cancer; Ovarian Cancer; Pancreatic Cancer; Prostate Cancer; Sarcoma

A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin
Status: Active, not recruiting Condition: Malignant Solid Tumor

Gemcitabine Pharmacokinetics
Status: Active, not recruiting Condition: Pancreatic Cancer

Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
Status: Active, not recruiting Condition: Pancreatic Cancer

Ipilimumab and Gemcitabine Hydrochloride in Treating Patients With Stage III-IV or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
Status: Recruiting Condition: Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas
Status: Terminated Condition: Adenocarcinoma of the Pancreas; Advanced Solid Tumors; Cancer; Cancer of Pancreas; Cancer of the Pancreas; Metastases; Metastatic Cancer; Metastatic Pancreatic Cancer; Pancreas Cancer; Pancreatic Cancer; Bone Metastases; Endocrine Cancer; Oncology; Oncology Patients; Solid Tumors; Advanced Malignancy

Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
Status: Active, not recruiting Condition: Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer

Eribulin Mesylate and Gemcitabine Hydrochloride in Treating Patients With Metastatic Solid Tumors or Solid Tumors That Cannot be Removed by Surgery
Status: Active, not recruiting Condition: Adult Solid Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Uterine Corpus Carcinoma; Stage III Ovarian Cancer; Stage III Uterine Corpus Cancer; Stage IV Ovarian Cancer; Stage IV Uterine Corpus Cancer

Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors
Status: Completed Condition: Solid Tumors

Gemcitabine Plus Busulfan, Melphalan and Hematopoietic Cell Transplant for Advanced Lymphoid Malignancies
Status: Completed Condition: Leukemia; Lymphoma; Myeloma

Gemcitabine and Pulse Dose Erlotinib in Second Line Treatment of Advanced Pancreatic Cancer
Status: Recruiting Condition: Pancreatic Cancer

Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Status: Active, not recruiting Condition: Pancreatic Cancer

Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies
Status: Recruiting Condition: Advanced Cancer

Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
Status: Active, not recruiting Condition: Stage IV Pancreatic Cancer

Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma
Status: Recruiting Condition: Resectable Pancreatic Adenocarcinoma

MK-0646 and Gemcitabine +/- Erlotinib for Patients With Advanced Pancreatic Cancer
Status: Active, not recruiting Condition: Pancreatic Cancer; Pancreatic Adenocarcinoma

A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer
Status: Completed Condition: Pancreatic Cancer

Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies
Status: Completed Condition: Relapsed or Refractory Lymphoproliferative Malignancies; Hodgkin's Lymphoma; Peripheral T-cell Lymphoma; B-cell Lymphoma; Waldenstrom's Macroglobulinemia

Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies
Status: Completed Condition: Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Testicular Lymphoma; Waldenstrom Macroglobulinemia

Bortezomib and Gemcitabine in Treating Patients With Recurrent or Metastatic Nasopharyngeal Cancer
Status: Completed Condition: Recurrent Nasopharyngeal Cancer; Stage IV Nasopharyngeal Cancer

Gemcitabine Hydrochloride and Smac Mimetic TL32711 in Treating Patients With Advanced Solid Tumors
Status: Terminated Condition: Unspecified Adult Solid Tumor, Protocol Specific

Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
Status: Completed Condition: Endometrial Cancer

Gemcitabine With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Status: Completed Condition: Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
Status: Completed Condition: Breast Cancer

S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Status: Completed Condition: Stage IV Pancreatic Cancer

Pemetrexed Plus Gemcitabine in Renal Cell Cancer
Status: Terminated Condition: Renal Cell Carcinoma

Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer
Status: Active, not recruiting Condition: Bladder Urothelial Carcinoma; Distal Urethral Carcinoma; Infiltrating Bladder Urothelial Carcinoma Associated With Urethral Carcinoma; Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter; Proximal Urethral Carcinoma; Recurrent Bladder Carcinoma; Recurrent Prostate Carcinoma; Recurrent Urethra Carcinoma; Recurrent Urothelial Carcinoma of the Renal Pelvis and Ureter; Regional Urothelial Carcinoma of the Renal Pelvis and Ureter; Stage IV Bladder Cancer; Stage IV Prostate Cancer; Stage IV Urethral Cancer; Ureter Carcinoma

PiCCA Study (Panitumumab in Combination With Cisplatin/Gemcitabine)
Status: Recruiting Condition: Cholangiocarcinomas

Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
Status: Terminated Condition: Pancreatic Neoplasms; Pancreatic Cancer

Sirolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients At High Risk for Cholangiocarcinoma Recurrence After Liver Transplant or Surgery
Status: Recruiting Condition: Hepatic Complications

AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer
Status: Completed Condition: Pancreatic Neoplasms

Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Status: Recruiting Condition: Malignant Ovarian Mixed Epithelial Tumor; Ovarian Brenner Tumor; Ovarian Carcinosarcoma; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Serous Surface Papillary Adenocarcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Undifferentiated Ovarian Carcinoma

Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer
Status: Recruiting Condition: Adenocarcinoma of the Bladder; Recurrent Bladder Cancer; Stage II Bladder Cancer; Stage III Bladder Cancer; Stage IV Bladder Cancer; Transitional Cell Carcinoma of the Bladder

Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
Status: Active, not recruiting Condition: Distal Urethral Cancer; Proximal Urethral Cancer; Squamous Cell Carcinoma of the Bladder; Stage II Bladder Cancer; Stage III Bladder Cancer; Urethral Cancer Associated With Invasive Bladder Cancer

Lag-3 and Gemcitabine for Treatment of Advanced Pancreas Cancer
Status: Terminated Condition: Pancreatic Neoplasms

Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor
Status: Terminated Condition: Neoplasms, Malignant

A Study of BBI608 in Combination With Gemcitabine and Nab-Paclitaxel in Adult Patients With Metastatic Pancreatic Adenocarcinoma
Status: Recruiting Condition: Metastatic Pancreatic Adenocarcinoma

Combination Chemotherapy, Gemcitabine Hydrochloride, and Radiation Therapy Before Surgery in Treating Patients With Borderline Resectable Pancreatic Cancer
Status: Recruiting Condition: Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage III Pancreatic Cancer

Safety and Efficacy Study of P276-00 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer
Status: Completed Condition: Pancreatic Cancer

Gemcitabine and Dasatinib in Advanced Solid Tumors
Status: Completed Condition: Advanced Cancer; Solid Tumors

Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer
Status: Recruiting Condition: Borderline Resectable Pancreatic Cancer

PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer
Status: Recruiting Condition: Metastatic Pancreatic Cancer

Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer
Status: Active, not recruiting Condition: Recurrent Breast Carcinoma; Stage IV Breast Cancer

A Phase I/II Study Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas
Status: Recruiting Condition: Cholangiocarcinoma

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
Status: Recruiting Condition: Malignant Ovarian Mixed Epithelial Tumor; Ovarian Brenner Tumor; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Undifferentiated Ovarian Carcinoma

Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies
Status: Active, not recruiting Condition: Lymphoma

Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery
Status: Recruiting Condition: Stage IA Uterine Sarcoma; Stage IB Uterine Sarcoma; Stage IC Uterine Sarcoma; Stage IIA Uterine Sarcoma; Stage IIB Uterine Sarcoma; Stage IIIA Uterine Sarcoma; Stage IIIB Uterine Sarcoma; Stage IIIC Uterine Sarcoma; Stage IVA Uterine Sarcoma; Stage IVB Uterine Sarcoma; Uterine Leiomyosarcoma

Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Status: Recruiting Condition: Male Breast Cancer; Recurrent Breast Cancer; Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

Randomized Phase II Trial of Pre-Operative Gemcitabine and Nab Paclitacel With or With Out Hydroxychloroquine
Status: Recruiting Condition: Pancreatic Cancer

Study of Sorafenib, Gemcitabine, and Cisplatin in Advanced Hepatocellular Carcinoma (HCC)
Status: Withdrawn Condition: Hepatocellular Carcinoma

Study of Low-Dose Radiation Therapy to the Whole Liver in Combination With Gemcitabine and Cisplatin in Intrahepatic Cholangiocarcinoma
Status: Recruiting Condition: Intrahepatic Cholangiocarcinoma

Allogeneic Stem Cell Transplant for Chronic Lymphocytic Leukemia (CLL)
Status: Recruiting Condition: Leukemia

Zactima in Non Small Cell Lung Cancer (NSCLC) ELderly Patients In Combination With or Versus Gemcitabine
Status: Completed Condition: Non Small Cell Lung Cancer

Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Vulva
Status: Recruiting Condition: Squamous Cell Carcinoma of the Vulva; Stage IIIA Vulvar Cancer; Stage IIIB Vulvar Cancer; Stage IIIC Vulvar Cancer; Stage IVA Vulvar Cancer

Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
Status: Completed Condition: Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer

Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer
Status: Active, not recruiting Condition: Recurrent Pancreatic Carcinoma; Stage IV Pancreatic Cancer

Combination Sunitinib and Gemcitabine in Sarcomatoid and/or Poor-risk Patients With Metastatic Renal Cell Carcinoma
Status: Active, not recruiting Condition: Renal Cell Carcinoma; Neoplasm Metastases

Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
Status: Not yet recruiting Condition: Bladder Urothelial Carcinoma; Recurrent Bladder Carcinoma; Stage III Bladder Cancer; Stage IV Bladder Cancer

Phase I Study of Gemcitabine, Sorafenib and Radiotherapy in Patients With Unresectable Pancreatic Cancer
Status: Active, not recruiting Condition: Pancreatic Cancer; Adenocarcinoma of the Pancreas

Sorafenib Tosylate and Gemcitabine Hydrochloride in Treating Patients With Recurrent Epithelial Ovarian Cancer
Status: Completed Condition: Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer

Doxil, Gemcitabine, and Velcade (PS341) in Advanced Cancer Patients
Status: Completed Condition: Solid Tumors

Gemcitabine and Split-dose Cisplatin (GC) Plus Sorafenib in Chemotherapy-naïve Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Status: Completed Condition: Bladder Cancer; URINARY BLADDER

Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Status: Recruiting Condition: Adult Lymphocyte Depletion Hodgkin Lymphoma; Adult Lymphocyte Predominant Hodgkin Lymphoma; Adult Mixed Cellularity Hodgkin Lymphoma; Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma; Adult Nodular Sclerosis Hodgkin Lymphoma; Recurrent Adult Hodgkin Lymphoma

Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
Status: Active, not recruiting Condition: Pancreatic Cancer Stage II

Huachansu & Gemcitabine in Pancreatic Cancer
Status: Completed Condition: Pancreatic Cancer

Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Status: Completed Condition: Head and Neck Cancer

Phase 1 Study of PI3 (Phosphatidylinositol-3)-Kinase Inhibitor Copanlisib With Gemcitabine or Cisplatin Plus Gemcitabine in Patients With Advanced Cancer
Status: Active, not recruiting Condition: Neoplasms

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Totowa
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION079160Jul 25, 2011RXNo<disabled><disabled>
Dr Reddys Labs Ltd
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION091365Jul 25, 2011RXNo<disabled><disabled>
Hospira Inc
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION200795Aug 4, 2011RXYes<disabled><disabled>
Cipla Ltd
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION078759Jul 25, 2011RXNo<disabled><disabled>
Teva Pharms
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION077983Jan 25, 2011RXNo<disabled><disabled>
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