CLINICAL TRIALS PROFILE FOR GEMCITABINE HYDROCHLORIDE

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)	Completed	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.
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.

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.
NCT00003001 ↗	Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer	Unknown status	Stony Brook University	Phase 1/Phase 2	1997-04-01	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 combination chemotherapy consisting of fluorouracil, leucovorin, and gemcitabine in treating patients with recurrent or metastatic colorectal cancer.

Clinical Trial Conditions for Gemcitabine Hydrochloride

Condition Name

Condition Name for Gemcitabine Hydrochloride
Intervention	Trials
Pancreatic Cancer	425
Breast Cancer	107
Lung Cancer	105
Bladder Cancer	97

Condition MeSH

Condition MeSH for Gemcitabine Hydrochloride
Intervention	Trials
Pancreatic Neoplasms	801
Carcinoma, Non-Small-Cell Lung	366
Adenocarcinoma	363
Lung Neoplasms	350

Clinical Trial Locations for Gemcitabine Hydrochloride

Trials by Country

Trials by Country for Gemcitabine Hydrochloride
Location	Trials
United States	8,979
China	705
Italy	599
Canada	564
Spain	502

Trials by US State

Trials by US State for Gemcitabine Hydrochloride
Location	Trials
California	459
New York	448
Texas	427
Pennsylvania	366
Florida	360

Clinical Trial Progress for Gemcitabine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Gemcitabine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	29
Phase 3	412
Phase 2/Phase 3	69

Clinical Trial Status

Clinical Trial Status for Gemcitabine Hydrochloride
Clinical Trial Phase	Trials
Completed	1199
Recruiting	467
Terminated	317

Clinical Trial Sponsors for Gemcitabine Hydrochloride

Sponsor Name

Sponsor Name for Gemcitabine Hydrochloride
Sponsor	Trials
National Cancer Institute (NCI)	426
Eli Lilly and Company	181
Hoffmann-La Roche	66

Sponsor Type

Sponsor Type for Gemcitabine Hydrochloride
Sponsor	Trials
Other	3016
Industry	1546
NIH	438

Gemcitabine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Gemcitabine Hydrochloride

Gemcitabine hydrochloride is a potent chemotherapeutic agent used in the treatment of various types of cancer, including pancreatic, ovarian, breast, and non-small cell lung cancer. It functions as an antimetabolite, inhibiting the formation of RNA and DNA in cancer cells, thereby halting their growth and proliferation.

Clinical Trials and Efficacy

Phase 3 Trials: NCIC CTG PA.3 Study

One of the significant clinical trials involving gemcitabine hydrochloride is the National Cancer Institute of Canada Clinical Trials Group PA.3 (NCIC CTG PA.3) study. This phase 3 trial evaluated the combination of gemcitabine with the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib in patients with advanced pancreatic carcinoma. The study demonstrated benefits in overall survival and progression-free survival for patients receiving the combination therapy compared to those receiving gemcitabine alone. However, the analysis of KRAS mutation status and EGFR gene copy number did not identify these as predictive markers for the survival benefit from the combination therapy[1].

Phase II Trials: Gemcitabine and Cisplatin

Another ongoing clinical trial is the phase II study (NCT03609216) that investigates the efficacy of gemcitabine hydrochloride in combination with cisplatin for treating invasive bladder urothelial cancer. This trial aims to determine how well this combination works in stopping the growth of tumor cells by either killing them, preventing them from dividing, or stopping them from spreading[4].

Market Analysis

Current Market Size and Growth

The global market for gemcitabine hydrochloride is substantial and growing. As of 2023, the market size was estimated at approximately $727.5 million[5] and $770.4 million[3], respectively, according to different reports. The market is projected to grow significantly over the next decade.

Growth Projections

The gemcitabine hydrochloride market is expected to grow at a Compound Annual Growth Rate (CAGR) of 7% from 2023 to 2033, reaching a market size of $1.43 billion by 2033[5]. Another report suggests a CAGR of 5.1% from 2023 to 2030, with the market projected to reach $1.1 billion by 2030[3].

Drivers of Market Growth

Several factors are driving the growth of the gemcitabine hydrochloride market:

• Rising Prevalence of Cancer: The increasing global incidence of cancer, particularly lung, pancreatic, and breast cancers, is a significant driver. According to the World Health Organization, an estimated 1.9 million new cancer cases were diagnosed in the United States in 2021 alone[2].
• Advancements in Drug Formulations: Ongoing research into novel formulations such as gemcitabine conjugates and prodrugs is enhancing the therapeutic efficacy and reducing the frequency of administration. These advancements are expected to contribute significantly to market growth[3].
• Combination Therapies: The use of gemcitabine in combination with other chemotherapeutic agents, checkpoint inhibitors, and targeted therapies is expanding its therapeutic scope and improving patient outcomes. This has led to a surge in clinical trials and new approvals[3].
• Generic and Biosimilar Versions: The development of generic and biosimilar versions of gemcitabine is making the drug more affordable, increasing its adoption, especially in cost-sensitive markets[3].
• Healthcare Expenditure: Rising healthcare expenditure in emerging economies, such as China and India, is enabling greater access to cancer treatments, creating new opportunities for the gemcitabine hydrochloride market[3].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the gemcitabine hydrochloride market. The pandemic highlighted the drug's potential anti-viral properties, particularly its difluoro group, which is essential for its antiviral action. Studies suggested that gemcitabine could be used in combination with other antiviral medications, such as remdesivir, for treating SARS-CoV-2 infection. This potential benefit increased the demand for gemcitabine hydrochloride during the pandemic period[2].

Market Dynamics and Healthcare Policies

Early Diagnosis and Treatment

Government screening programs and awareness campaigns are leading to higher detection rates of cancer, which in turn increases the usage of effective chemotherapeutic agents like gemcitabine. These initiatives are supported by healthcare policies that emphasize early diagnosis and treatment of cancer[3].

Strategic Alliances and Local Production

Pharmaceutical companies are forming strategic alliances and investing in local production facilities to cater to the growing demand for gemcitabine hydrochloride, especially in emerging economies. This approach helps in making the drug more accessible and affordable[3].

Future Outlook

The future of the gemcitabine hydrochloride market looks promising due to several ongoing developments:

• Novel Formulations: Continuous innovation in drug delivery and formulation technologies is expected to enhance the therapeutic efficacy and reduce the frequency of administration, contributing to market growth[3].
• Combination Therapies: Research into combination therapies using gemcitabine with newer immunotherapeutic agents and targeted therapies is expected to develop more comprehensive treatment regimens for various cancers[3].

Key Takeaways

• Gemcitabine hydrochloride is a crucial chemotherapeutic agent with proven efficacy in treating various cancers.
• Clinical trials, such as the NCIC CTG PA.3 study, have demonstrated its benefits in combination therapies.
• The global market for gemcitabine hydrochloride is projected to grow significantly, driven by the rising prevalence of cancer, advancements in drug formulations, and increasing acceptance of combination therapies.
• The COVID-19 pandemic highlighted the drug's potential anti-viral properties, contributing to increased demand.
• Ongoing research and development in novel formulations and combination therapies are expected to further expand the market.

FAQs

What is gemcitabine hydrochloride used for?

Gemcitabine hydrochloride is used in the treatment of various types of cancer, including pancreatic, ovarian, breast, and non-small cell lung cancer.

What was the outcome of the NCIC CTG PA.3 study?

The NCIC CTG PA.3 study demonstrated benefits in overall survival and progression-free survival for patients receiving gemcitabine in combination with erlotinib, but did not identify KRAS mutation status and EGFR gene copy number as predictive markers for this benefit.

How is the COVID-19 pandemic impacting the gemcitabine hydrochloride market?

The COVID-19 pandemic increased the demand for gemcitabine hydrochloride due to its potential anti-viral properties and its use in combination with other antiviral medications.

What are the key drivers of the gemcitabine hydrochloride market growth?

The key drivers include the rising prevalence of cancer, advancements in drug formulations, increasing acceptance of combination therapies, and the development of generic and biosimilar versions.

What is the projected market size of gemcitabine hydrochloride by 2033?

The global market for gemcitabine hydrochloride is projected to reach $1.43 billion by 2033, growing at a CAGR of 7% from 2023 to 2033[5].

Sources

1. National Cancer Institute of Canada Clinical Trials Group Study PA.3 - Molecular predictors of outcome in a phase 3 study of gemcitabine and erlotinib therapy in patients with advanced pancreatic cancer[1].
2. Gemcitabine Hydrochloride Market Size & Share Analysis - Mordor Intelligence[2].
3. Gemcitabine Hydrochloride Strategic Industry Research Report 2023-2030 - GlobeNewswire[3].
4. NCT03609216 – A Phase II Study of Gemcitabine Plus Cisplatin - University of Arkansas for Medical Sciences[4].
5. Gemcitabine HCl Market Size, Demand & Sales Forecast - Fact.MR[5].

Last updated: 2024-12-31