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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR CISPLATIN


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505(b)(2) Clinical Trials for Cisplatin

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 NCT00130520 ↗ Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer Completed Genentech, Inc. Phase 2 2005-06-01 The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination NCT00130520 ↗ Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer Completed University of Arizona Phase 2 2005-06-01 The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cisplatin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001272 ↗ A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients Completed National Cancer Institute (NCI) Phase 1 1991-09-01 This is a Phase I study which addresses the feasibility and toxicity of adding taxol to the two drug combination which now comprises the standard of care in newly diagnosed advanced stage ovarian cancer, cisplatin and cyclophosphamide. These drugs will be given in a dose intensive fashion with the colony-stimulating factor, G-CSF. Newly diagnosed patients with ovarian cancer will be treated with this regimen to determine the optimal dose of this combination. The pharmacokinetics of taxol and cisplatin DNA-adducts will be studied as well.
NCT00001426 ↗ A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer Completed National Cancer Institute (NCI) Phase 2 1995-02-03 A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
NCT00001427 ↗ A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin Completed National Cancer Institute (NCI) Phase 2 1995-01-01 The objectives of this study are to determine the response rate to 9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based chemotherapy regimens.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cisplatin

Condition Name

Condition Name for Cisplatin
Intervention Trials
Head and Neck Cancer 198
Lung Cancer 175
Non-Small Cell Lung Cancer 156
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Condition MeSH

Condition MeSH for Cisplatin
Intervention Trials
Carcinoma 791
Lung Neoplasms 743
Carcinoma, Non-Small-Cell Lung 606
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Clinical Trial Locations for Cisplatin

Trials by Country

Trials by Country for Cisplatin
Location Trials
Canada 926
Japan 916
Italy 792
France 649
United Kingdom 647
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Trials by US State

Trials by US State for Cisplatin
Location Trials
New York 586
California 551
Texas 542
Pennsylvania 458
Illinois 450
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Clinical Trial Progress for Cisplatin

Clinical Trial Phase

Clinical Trial Phase for Cisplatin
Clinical Trial Phase Trials
Phase 4 53
Phase 3 806
Phase 2/Phase 3 114
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Clinical Trial Status

Clinical Trial Status for Cisplatin
Clinical Trial Phase Trials
Completed 1508
Recruiting 713
Unknown status 458
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Clinical Trial Sponsors for Cisplatin

Sponsor Name

Sponsor Name for Cisplatin
Sponsor Trials
National Cancer Institute (NCI) 650
Merck Sharp & Dohme Corp. 132
Sun Yat-sen University 124
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Sponsor Type

Sponsor Type for Cisplatin
Sponsor Trials
Other 4935
Industry 1655
NIH 663
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Cisplatin: Clinical Trials, Market Analysis, and Projections

Introduction to Cisplatin

Cisplatin is a platinum-based chemotherapy drug widely used in the treatment of various types of cancer, including testicular, ovarian, lung, and bladder cancers. Its efficacy and broad-spectrum activity have made it a cornerstone in oncology treatment protocols.

Clinical Trials and Recent Findings

Head and Neck Cancer Trials

In recent clinical trials, cisplatin has been compared with other treatment options for patients with locally advanced head and neck cancer who are unable to receive cisplatin due to underlying health conditions. A study published in the Lancet Oncology found that cetuximab, a targeted therapy, outperformed durvalumab, an immunotherapy drug, when combined with radiation therapy. However, this study also highlighted the challenges and uncertainties in treating this understudied population, where cisplatin is often the standard but not always feasible[1].

Another clinical trial, NRG-HN009, is currently comparing two schedules of cisplatin administration (every three weeks versus every week) in combination with radiation therapy for patients with advanced head and neck cancer. This study aims to determine if the weekly cisplatin schedule is better tolerated and as effective as the traditional every-three-weeks schedule[4].

Efficacy and Tolerability

Clinical trials have consistently shown that cisplatin is highly effective against solid tumors, particularly in combination with other chemotherapy agents or radiation therapy. However, its use is often limited by side effects such as nephrotoxicity, hearing loss, and peripheral neuropathy. Ongoing research focuses on improving the tolerability and efficacy of cisplatin through innovative formulations and delivery systems, such as nano-formulations and targeted delivery mechanisms[3][5].

Market Analysis

Market Size and Growth

The cisplatin market was valued at USD 14.2 billion in 2023 and is projected to reach USD 25.6 billion by 2031, growing at a CAGR of 8.23%. This growth is driven by the increasing incidence of cancer, particularly lung, testicular, and ovarian cancers, and the continued demand for effective chemotherapy agents[3].

Segment Analysis

The cisplatin market is segmented by application, with significant shares in the treatment of ovarian, testicular, and bladder cancers. Cisplatin is the gold standard for testicular cancer treatment and is frequently used in combination chemotherapy for ovarian and bladder cancers. The market is also segmented geographically, with North America dominating the global share due to high cancer incidence rates and advanced healthcare infrastructure[2][3].

Key Players and Market Dynamics

Major players in the cisplatin market include Teva Pharmaceutical Industries Ltd., Accord Healthcare, Novartis AG, Sun Pharmaceutical Industries Ltd., and Pfizer, Inc. These companies are involved in strategic collaborations, partnerships, and acquisitions to enhance the production and distribution of cisplatin. These efforts include improving drug formulations, conducting clinical trials, and expanding market reach[2][3].

Market Projections

Growing Demand for Chemotherapy Agents

The increasing number of cancer patients and the evolving treatment regimens are driving the demand for chemotherapy agents like cisplatin. The global trend toward personalized medicine and the rise of combination therapies further propel the utilization of cisplatin in oncology settings[3].

Technological Advancements

Advancements in drug delivery systems and formulations are expected to enhance the efficacy and safety profile of cisplatin. Innovations such as nano-formulations and targeted delivery mechanisms are improving the therapeutic index of cisplatin, making it more tolerable for patients and increasing its adoption[3].

Regional Growth

North America is expected to continue dominating the global cisplatin market, followed by Europe and the Asia Pacific region. The growing healthcare infrastructure in developing countries and increasing awareness about cancer will positively impact the industry growth in these regions[2][5].

Challenges and Future Directions

Side Effects and Resistance

Despite its efficacy, cisplatin's use is limited by its side effects, particularly nephrotoxicity. Ongoing research aims to mitigate these side effects through new formulations and delivery systems. Additionally, efforts to circumvent resistance processes and broaden the clinical usefulness of platinum-based drugs, such as the development of carboplatin and oxaliplatin, are ongoing[5].

Clinical Trials and Research

Future clinical trials will focus on optimizing treatment schedules, such as the NRG-HN009 study, and exploring new combinations of cisplatin with other therapeutic agents. Government and institutional funding for cancer research will continue to play a crucial role in driving these efforts[4].

"Cisplatin is a platinum-based drug primarily known for its effectiveness against solid tumors, and its applications are vital in enhancing patient outcomes. As cancer treatment regimens continue to evolve, the demand for chemotherapy agents like cisplatin is witnessing a significant uptick."[3]

Key Takeaways

  • Clinical Trials: Ongoing trials compare cisplatin with other treatments and explore optimal administration schedules to improve efficacy and tolerability.
  • Market Growth: The cisplatin market is projected to grow significantly, driven by increasing cancer incidence and demand for effective chemotherapy agents.
  • Technological Advancements: Innovations in drug delivery systems and formulations are enhancing the safety and efficacy of cisplatin.
  • Regional Dynamics: North America dominates the market, but growth is expected in other regions due to improving healthcare infrastructure.
  • Challenges: Mitigating side effects and overcoming resistance remain key challenges and areas of ongoing research.

FAQs

What is the current market size of the cisplatin market?

The cisplatin market was valued at USD 14.2 billion in 2023[3].

What is the projected growth rate of the cisplatin market?

The cisplatin market is projected to grow at a CAGR of 8.23% from 2023 to 2031[3].

What are the main applications of cisplatin in cancer treatment?

Cisplatin is primarily used in the treatment of ovarian, testicular, and bladder cancers[3].

What are the major side effects associated with cisplatin?

The major side effects include nephrotoxicity, hearing loss, and peripheral neuropathy[3][5].

Are there ongoing efforts to improve the tolerability of cisplatin?

Yes, ongoing research focuses on improving formulations and delivery systems to mitigate side effects and enhance efficacy[3][5].

Sources

  1. National Cancer Institute: "Cetuximab Outperforms Durvalumab for Head and Neck Cancer" - Cancer Currents Blog, December 19, 2024.
  2. GlobeNewswire: "Platinum based cancer drugs market size to reach US$1.8 billion by 2026" - March 25, 2020.
  3. Verified Market Research: "Cisplatin Market Size, Scope, Growth, Trends and Forecast" - 2023.
  4. NRG Oncology: "NRG-HN009: Cisplatin and Radiation for Advanced Head and Neck Cancer" - Clinical Trial.
  5. Polaris Market Research: "Platinum Based Cancer Drugs Market Size - Global Industry Report" - 2023.

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