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Last Updated: January 22, 2020

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CLINICAL TRIALS PROFILE FOR GEMCITABINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Gemcitabine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00003589 Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 3 1998-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.
New Combination NCT01050322 Safety Study in Subjects With Metastatic Breast Cancer Who Progressed After Taxanes Treatment. Completed GlaxoSmithKline Phase 2 2009-11-01 Despite these initial positive signals in recent statistics, breast cancer continues to claim a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current treatment paradigm - surgery, radiation and systemic chemo and or hormonal therapy and biological therapies -still fails to cure a significant number of women with early breast cancer and new treatment strategies are needed to improve current results both in early and advance disease. Recurrent or metastatic breast cancer is an incurable malignancy with a median survival of 20-24 months [Hortobagyi , 1998] and this has not changed significantly over the last decade with fewer than 20% of patients still alive at 5 years after a diagnosis of recurrence. Although there have been small improvements in survival with the new therapies, metastatic breast cancer remains an incurable and, ultimately, fatal disease. The introduction of novel combination therapies have the potential to target different pathways in the cancer cell, leading to improved efficacy. Further studies to optimize combination therapy, while ameliorating AEs, are critically important to patients with metastatic breast cancer. Lapatinib is an oral tyrosine kinase inhibitor which potently inhibits both EGFR and HER2[Spector, 2005]. Lapatinib in combination with capecitabine is approved in more than 20 countries for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2. All patients in the study leading to the lapatinib approval had received prior therapy including an anthracycline, a taxane, and trastuzumab. The relevance of the HER2/neu target in breast cancer, combined with the promising preclinical and clinical data regarding the use of lapatinib, provide the rationale for a formal evaluation of this agent combined with other non taxane agents as gemcitabine or vinorelbine after progression on taxanes and trastuzumab based therapies in metastatic disease setting as these chemotherapy options are used in daily practice in this subset of patients. This is a randomized phase II, open label,multicentric , international, 3 arms treatment study in patients with confirmed HER2+ metastatic breast cancer after taxane progression . The main objective is to investigate the (CBR) and safety in 3 different combinations of Lapatinib therapy (plus capecitabine or gemcitabine or vinorelbine) and to determine whether either, or both, of Lapatinib /Vinorelbine or Lapatinib/Gemcitabine can be considered a reasonable alternative to the established Lapatinib/Capecitabine standard combination . The decision as to whether to study either of the new combinations further will be based on both the toxicity and the efficacy profiles.
New Combination NCT01050322 Safety Study in Subjects With Metastatic Breast Cancer Who Progressed After Taxanes Treatment. Completed Latin American Cooperative Oncology Group Phase 2 2009-11-01 Despite these initial positive signals in recent statistics, breast cancer continues to claim a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current treatment paradigm - surgery, radiation and systemic chemo and or hormonal therapy and biological therapies -still fails to cure a significant number of women with early breast cancer and new treatment strategies are needed to improve current results both in early and advance disease. Recurrent or metastatic breast cancer is an incurable malignancy with a median survival of 20-24 months [Hortobagyi , 1998] and this has not changed significantly over the last decade with fewer than 20% of patients still alive at 5 years after a diagnosis of recurrence. Although there have been small improvements in survival with the new therapies, metastatic breast cancer remains an incurable and, ultimately, fatal disease. The introduction of novel combination therapies have the potential to target different pathways in the cancer cell, leading to improved efficacy. Further studies to optimize combination therapy, while ameliorating AEs, are critically important to patients with metastatic breast cancer. Lapatinib is an oral tyrosine kinase inhibitor which potently inhibits both EGFR and HER2[Spector, 2005]. Lapatinib in combination with capecitabine is approved in more than 20 countries for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2. All patients in the study leading to the lapatinib approval had received prior therapy including an anthracycline, a taxane, and trastuzumab. The relevance of the HER2/neu target in breast cancer, combined with the promising preclinical and clinical data regarding the use of lapatinib, provide the rationale for a formal evaluation of this agent combined with other non taxane agents as gemcitabine or vinorelbine after progression on taxanes and trastuzumab based therapies in metastatic disease setting as these chemotherapy options are used in daily practice in this subset of patients. This is a randomized phase II, open label,multicentric , international, 3 arms treatment study in patients with confirmed HER2+ metastatic breast cancer after taxane progression . The main objective is to investigate the (CBR) and safety in 3 different combinations of Lapatinib therapy (plus capecitabine or gemcitabine or vinorelbine) and to determine whether either, or both, of Lapatinib /Vinorelbine or Lapatinib/Gemcitabine can be considered a reasonable alternative to the established Lapatinib/Capecitabine standard combination . The decision as to whether to study either of the new combinations further will be based on both the toxicity and the efficacy profiles.
New Combination NCT01270724 Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Recruiting Nationwide Children's Hospital Phase 2 2010-08-01 This study will look to see how well patients with relapsed or recurrent intracranial germ cell tumors respond to the new combination of chemotherapy (in induction)of Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) followed by consolidation chemotherapy and autologous stem cell rescue.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Gemcitabine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001431 A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas Completed National Cancer Institute (NCI) Phase 1 1995-02-01 Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.
NCT00001449 A Phase I Study of Weekly Gemcitabine in Combination With Infusional Fluorodeoxyuridine and Oral Calcium Leucovorin in Adult Cancer Patients Completed National Cancer Institute (NCI) Phase 1 1995-09-01 The purpose of this study is to determine the clinical toxicities associated with administering sequential dFdC as a one hour infusion followed by a continuous infusion of FUdR over 24 hours with low dose oral LV weekly for three weeks out of four.
NCT00002998 Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer Completed National Cancer Institute (NCI) Phase 2 1997-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating patients with metastatic breast cancer that has not responded to systemic therapy.
NCT00002998 Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer Completed Alliance for Clinical Trials in Oncology Phase 2 1997-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating patients with metastatic breast cancer that has not responded to systemic therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gemcitabine Hydrochloride

Condition Name

Condition Name for Gemcitabine Hydrochloride
Intervention Trials
Pancreatic Cancer 369
Lung Cancer 97
Breast Cancer 92
Bladder Cancer 87
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Condition MeSH

Condition MeSH for Gemcitabine Hydrochloride
Intervention Trials
Pancreatic Neoplasms 671
Carcinoma, Non-Small-Cell Lung 318
Lung Neoplasms 306
Adenocarcinoma 282
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Clinical Trial Locations for Gemcitabine Hydrochloride

Trials by Country

Trials by Country for Gemcitabine Hydrochloride
Location Trials
United States 6,231
Italy 410
Canada 383
Spain 270
Germany 257
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Trials by US State

Trials by US State for Gemcitabine Hydrochloride
Location Trials
New York 330
California 314
Texas 296
Pennsylvania 265
Florida 253
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Clinical Trial Progress for Gemcitabine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Gemcitabine Hydrochloride
Clinical Trial Phase Trials
Phase 4 19
Phase 3 292
Phase 2/Phase 3 46
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Clinical Trial Status

Clinical Trial Status for Gemcitabine Hydrochloride
Clinical Trial Phase Trials
Completed 877
Recruiting 475
Not yet recruiting 217
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Clinical Trial Sponsors for Gemcitabine Hydrochloride

Sponsor Name

Sponsor Name for Gemcitabine Hydrochloride
Sponsor Trials
National Cancer Institute (NCI) 378
Eli Lilly and Company 163
Sanofi 52
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Sponsor Type

Sponsor Type for Gemcitabine Hydrochloride
Sponsor Trials
Other 2208
Industry 1080
NIH 387
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