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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR PLATINOL-AQ


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505(b)(2) Clinical Trials for Platinol-aq

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 Dosage NCT00968799 ↗ Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study Terminated Cantonal Hospital of St. Gallen N/A 2008-02-01 Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by the body surface is still highly variable and thus dosing on the body surface is increasingly considered controversial for systemic administration. For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes even less sense, since the aim is the highest possible drug concentration in the peritoneum without undue local and systemic toxicity. Furthermore, most studies using intraoperative chemotherapy vary the volume of the perfusate according to the size of the patient. Since the amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] = dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can vary considerably between patients. On the other hand pharmacokinetic analyses have shown that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy even if the amount of the drug remains the same. In this study the safety of a new dosing regime will be evaluated. The concentration of cisplatin in the perfusate will be held constant independent of body weight or size to achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of the treatment. All patients should be able to receive full dose systemic carboplatin chemotherapy after completion the trial treatment.
New Combination NCT05019716 ↗ Testing the Safety and Efficacy of the Addition of A New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Etoposide and Cisplatin) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma Not yet recruiting National Cancer Institute (NCI) Phase 1/Phase 2 2022-04-29 This phase I/II trial tests the safety, side effects, and best dose of a new combination of drugs, ZEN003694, cisplatin, and etoposide in treating patients with NUT carcinoma (phase I), and identifies whether this combination therapy works to shrink tumor in these patients (phase II). Another purpose of this study is to see whether there are any changes in patient's tumor or blood characteristics (e.g. genes, molecules, etc.) due to combination therapy. ZEN003694 inhibits the production of certain growth-promoting proteins and may prevent proliferation of tumor cells that use those proteins for their growth. Chemotherapy drugs, such as etoposide and cisplatin, work by stopping or slowing the growth of cancer cells. Combination therapy with ZEN003694, etoposide and cisplatin may be effective in treating patients with NUT carcinoma.
New Combination NCT05156970 ↗ Camrelizumab in Combination With Chemotherapy or Apatinib Mesylate as First-Line Treatment for R/M HNSCC Recruiting Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Phase 2 2021-06-24 This study is the first clinical study of first-line treatment of head and neck squamous cell carcinoma with drugs targeting VEGF signaling pathway combined with PD-1 inhibitors in China, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Platinol-aq

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002524 ↗ Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma Completed National Cancer Institute (NCI) Phase 2 1993-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗ Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma Completed M.D. Anderson Cancer Center Phase 2 1993-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002642 ↗ SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer Completed Cancer and Leukemia Group B Phase 2 1995-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and etoposide, in treating patients who have stage III non-small cell lung cancer.
NCT00002642 ↗ SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer Completed Eastern Cooperative Oncology Group Phase 2 1995-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and etoposide, in treating patients who have stage III non-small cell lung cancer.
NCT00002642 ↗ SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer Completed National Cancer Institute (NCI) Phase 2 1995-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and etoposide, in treating patients who have stage III non-small cell lung cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Platinol-aq

Condition Name

Condition Name for Platinol-aq
Intervention Trials
Head and Neck Cancer 20
Lung Cancer 14
Cervical Adenocarcinoma 13
Cervical Adenosquamous Carcinoma 13
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Condition MeSH

Condition MeSH for Platinol-aq
Intervention Trials
Carcinoma 129
Carcinoma, Squamous Cell 72
Lung Neoplasms 69
Carcinoma, Non-Small-Cell Lung 50
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Clinical Trial Locations for Platinol-aq

Trials by Country

Trials by Country for Platinol-aq
Location Trials
Japan 82
Australia 63
China 38
Poland 9
Belgium 9
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Trials by US State

Trials by US State for Platinol-aq
Location Trials
Texas 146
California 124
New York 114
Ohio 113
Pennsylvania 110
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Clinical Trial Progress for Platinol-aq

Clinical Trial Phase

Clinical Trial Phase for Platinol-aq
Clinical Trial Phase Trials
Phase 3 64
Phase 2/Phase 3 13
Phase 2 167
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Clinical Trial Status

Clinical Trial Status for Platinol-aq
Clinical Trial Phase Trials
Completed 106
Recruiting 82
Active, not recruiting 70
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Clinical Trial Sponsors for Platinol-aq

Sponsor Name

Sponsor Name for Platinol-aq
Sponsor Trials
National Cancer Institute (NCI) 190
M.D. Anderson Cancer Center 44
NRG Oncology 22
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Sponsor Type

Sponsor Type for Platinol-aq
Sponsor Trials
Other 336
NIH 191
Industry 111
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PLATINOL-AQ: Clinical Trials, Market Analysis, and Projections

Introduction to PLATINOL-AQ

PLATINOL-AQ, commonly known as cisplatin, is a platinum-based chemotherapeutic agent widely used in the treatment of various cancers, including testicular, ovarian, lung, bladder, and stomach cancers. Here, we will delve into recent clinical trials, market analysis, and future projections for this crucial drug.

Recent Clinical Trials and Outcomes

Advanced Bladder Cancer Trials

Recent clinical trials have highlighted significant advancements in the treatment of advanced bladder cancer using combination therapies that include cisplatin. For instance, the EV-302 trial demonstrated that the combination of enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) significantly improved survival rates compared to standard chemotherapy. Although cisplatin was not the primary focus of this trial, the success of combination therapies underscores the potential for cisplatin to be used in similar regimens to enhance treatment efficacy[1].

Combination Therapies

Clinical trials have consistently shown that combining cisplatin with other chemotherapy agents, targeted therapies, or immunotherapies can significantly improve treatment outcomes. For example, the combination of carboplatin (a related platinum-based drug) and paclitaxel has shown better overall response rates in ovarian cancer compared to using either drug alone. This trend suggests that cisplatin could also be effectively used in combination regimens to overcome resistance and reduce side effects[3].

Market Analysis

Global Market Size and Growth

The global platinum-based cancer drugs market, which includes cisplatin, was valued at USD 1310.3 million in 2018 and is expected to exhibit a CAGR of 4.1% over the forecast period. Cisplatin remains the dominant player in terms of market value due to its established role in treating multiple cancer types[3].

Regional Segmentation

The market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America dominated the global market in 2017 due to the high prevalence of cancer and recent FDA approvals. The Asia Pacific market is anticipated to expand at the highest CAGR owing to the rise in disease prevalence, increased awareness, and improvements in healthcare infrastructure[2][5].

Key Market Players

Major players operating in the platinum-based drugs market include Pfizer, Inc., Sanofi, Novartis AG, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and others. These companies are investing heavily in research and development to improve formulations and combination therapies[2][5].

Market Trends and Projections

Rising Adoption of Combination Therapies

There is a growing interest in using platinum-based drugs like cisplatin in combination with other agents to enhance therapeutic outcomes and overcome drug resistance. This trend is expected to continue, driving the market growth for platinum-based drugs[3].

Development of New Formulations

Efforts to develop new formulations, such as liposomal platinum compounds, aim to reduce side effects and improve patient outcomes. These advancements are expected to contribute significantly to the market development by addressing long-standing challenges of toxicity and treatment resistance[3].

Personalized Cancer Treatments

The growing emphasis on personalized cancer treatments, where therapies are tailored to individual patient profiles, is another trend that could impact the market. Platinum drugs, including cisplatin, are being integrated into personalized regimens based on genetic markers of tumors[3].

Challenges and Limitations

Adverse Side Effects

Cisplatin is known for its severe side effects, including nephrotoxicity, neurotoxicity, and gastrointestinal problems. These side effects limit its use in many cases and are a significant challenge for the market. New formulations and delivery systems are being developed to mitigate these issues[3][4].

Drug Resistance

The development of resistance by cancer cells is another major limitation. However, ongoing research into combination therapies and new formulations is aimed at circumventing this resistance and increasing the clinical usefulness of cisplatin and other platinum-based drugs[5].

Future Projections

Market Growth

The platinum-based cancer drugs market, including cisplatin, is expected to continue growing due to the increasing prevalence of cancer, advancements in combination therapies, and the development of new formulations. The market is projected to expand, driven by the rising adoption of personalized treatment approaches and the ongoing clinical research into more effective drug regimens[3][5].

Regional Expansion

The Asia Pacific region is anticipated to show the highest growth rate due to the rise in disease prevalence, increased awareness, and improvements in healthcare infrastructure. This region presents significant opportunities for market expansion and growth[2][5].

Key Takeaways

  • Clinical Trials: Recent trials have shown the efficacy of combination therapies involving platinum-based drugs, highlighting the potential for cisplatin in similar regimens.
  • Market Size and Growth: The global platinum-based cancer drugs market is expected to grow at a CAGR of 4.1%, with cisplatin remaining a dominant player.
  • Regional Segmentation: North America currently dominates the market, but the Asia Pacific region is expected to show the highest growth rate.
  • Market Trends: Combination therapies, new formulations, and personalized treatments are driving market growth.
  • Challenges: Adverse side effects and drug resistance remain significant challenges that are being addressed through ongoing research.

FAQs

What are the recent advancements in the use of cisplatin in clinical trials?

Recent clinical trials have shown that combination therapies involving platinum-based drugs can significantly improve survival rates and treatment efficacy, particularly in advanced bladder cancer.

Which regions are expected to drive the growth of the platinum-based drugs market?

The Asia Pacific region is anticipated to show the highest growth rate due to the rise in disease prevalence, increased awareness, and improvements in healthcare infrastructure.

What are the main challenges associated with the use of cisplatin?

The main challenges include severe side effects such as nephrotoxicity, neurotoxicity, and gastrointestinal problems, as well as the development of drug resistance by cancer cells.

How are new formulations of cisplatin addressing the challenges of toxicity and resistance?

New formulations, such as liposomal platinum compounds, are being developed to reduce side effects and improve patient outcomes. These formulations aim to enhance drug delivery to cancer cells while minimizing damage to healthy tissue.

What role do combination therapies play in the market growth of platinum-based drugs?

Combination therapies involving platinum-based drugs are a major growth driver, as they enhance therapeutic outcomes, reduce side effects, and overcome drug resistance.

Sources

  1. National Cancer Institute: "Padcev and Keytruda Double Bladder Cancer Survival"
  2. Biospace: "Platinum-based Drugs Market: Cisplatin segment held the largest share of the market"
  3. Polaris Market Research: "Platinum Based Cancer Drugs Market Size - Global Industry Report"
  4. FDA: "PLATINOL - accessdata.fda.gov"
  5. Allied Market Research: "Platinum based Drugs Market Size | Industry Growth By, 2030"

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