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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR GEMZAR


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505(b)(2) Clinical Trials for Gemzar

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 Formulation NCT01839487 ↗ PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer Completed Halozyme Therapeutics Phase 2 2013-05-14 This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG). This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
New Combination NCT01884428 ↗ Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma Unknown status Armando Santoro, MD Phase 1 2011-07-01 study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose
New Combination NCT03496662 ↗ BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting Bristol-Myers Squibb Phase 1/Phase 2 2018-08-31 The purpose of this research study is to learn more about a new combination of drugs being given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects and the way the disease responds to treatment.
New Combination NCT03496662 ↗ BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting National Cancer Institute (NCI) Phase 1/Phase 2 2018-08-31 The purpose of this research study is to learn more about a new combination of drugs being given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects and the way the disease responds to treatment.
New Combination NCT03496662 ↗ BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting National Institutes of Health (NIH) Phase 1/Phase 2 2018-08-31 The purpose of this research study is to learn more about a new combination of drugs being given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects and the way the disease responds to treatment.
New Combination NCT03496662 ↗ BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting The Foundation for Barnes-Jewish Hospital Phase 1/Phase 2 2018-08-31 The purpose of this research study is to learn more about a new combination of drugs being given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects and the way the disease responds to treatment.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Gemzar

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00003182 ↗ Cisplatin and Gemcitabine in Treating Patients With Advanced Squamous Cell Cancer of the Head and Neck Unknown status Hope Cancer Institute, Inc. Phase 1/Phase 2 1997-03-01 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 I/II trial to study the effectiveness of cisplatin and gemcitabine in treating patients with advanced squamous cell cancer of the head and neck that cannot be surgically removed.
NCT00003587 ↗ S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer Completed National Cancer Institute (NCI) Phase 2 1998-10-01 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: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
NCT00003587 ↗ S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer Completed Southwest Oncology Group Phase 2 1998-10-01 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: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
NCT00003744 ↗ Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery Completed National Cancer Institute (NCI) Phase 2 1998-11-01 The purpose of this study is to see how patients with incurable salivary gland cancer, who have not had chemotherapy before, respond to Gemcitabine. The investigators are trying to find out what effects (good and bad) Gemcitabine has on participants and salivary gland cancer. Gemcitabine has been shown to be an effective chemotherapy agent in other types of cancer, including; bladder cancer, breast cancer, certain types of lung cancer, ovarian cancer, and pancreas cancer. Gemcitabine has yet to be studied for efficacy in subjects with salivary gland cancer and in general other chemotherapy drugs have shown to be ineffective so far in this population.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gemzar

Condition Name

Condition Name for Gemzar
Intervention Trials
Pancreatic Cancer 109
Breast Cancer 39
Stage IV Pancreatic Cancer 34
Stage III Pancreatic Cancer 33
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Condition MeSH

Condition MeSH for Gemzar
Intervention Trials
Pancreatic Neoplasms 243
Adenocarcinoma 125
Lung Neoplasms 82
Carcinoma, Non-Small-Cell Lung 81
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Clinical Trial Locations for Gemzar

Trials by Country

Trials by Country for Gemzar
Location Trials
Spain 87
Germany 86
China 84
Australia 70
Japan 69
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Trials by US State

Trials by US State for Gemzar
Location Trials
Texas 158
California 146
Pennsylvania 124
New York 120
Florida 120
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Clinical Trial Progress for Gemzar

Clinical Trial Phase

Clinical Trial Phase for Gemzar
Clinical Trial Phase Trials
Phase 4 1
Phase 3 80
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for Gemzar
Clinical Trial Phase Trials
Completed 353
Terminated 110
Recruiting 82
[disabled in preview] 130
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Clinical Trial Sponsors for Gemzar

Sponsor Name

Sponsor Name for Gemzar
Sponsor Trials
National Cancer Institute (NCI) 185
Eli Lilly and Company 78
M.D. Anderson Cancer Center 42
[disabled in preview] 67
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Sponsor Type

Sponsor Type for Gemzar
Sponsor Trials
Other 662
Industry 410
NIH 192
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