CLINICAL TRIALS PROFILE FOR PLATINOL

505(b)(2) Clinical Trials for Platinol

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.

All Clinical Trials for Platinol

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.

Clinical Trial Conditions for Platinol

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Platinol

Trials by Country

Trials by Country for Platinol
Location	Trials
Japan	82
Australia	63
China	38
Poland	9
Belgium	9

Trials by US State

Trials by US State for Platinol
Location	Trials
Texas	146
California	124
New York	114
Ohio	113
Pennsylvania	110

Clinical Trial Progress for Platinol

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Platinol

Sponsor Name

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

Sponsor Type

Sponsor Type for Platinol
Sponsor	Trials
Other	336
NIH	191
Industry	111

PLATINOL: Clinical Trials, Market Analysis, and Projections

Introduction to PLATINOL

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

Clinical Trials and Recent Developments

Advanced Bladder Cancer Trials

Recent clinical trials have marked a significant milestone in the treatment of advanced bladder cancer. The EV-302 trial, which compared the combination of enfortumab (an antibody-drug conjugate) and pembrolizumab (an immunotherapy drug) with standard chemotherapy, showed remarkable results. Patients treated with the enfortumab-pembrolizumab combination had a doubling of survival rates compared to those receiving chemotherapy alone. This improvement is unprecedented in the treatment of advanced bladder cancer and has been hailed as a monumental achievement in the field[1].

While PLATINOL itself was not the primary focus of these trials, the success of combination therapies involving platinum-based drugs is a trend that continues to influence cancer treatment strategies. For instance, the use of cisplatin in combination with other agents, such as paclitaxel or pembrolizumab, has been shown to enhance treatment efficacy in various cancers[3].

Combination Therapies

The growing interest in combination therapies is a key trend in the platinum-based cancer drugs market. Clinical trials have demonstrated that combining platinum-based drugs like cisplatin with other chemotherapy agents, targeted therapies, or immunotherapies can significantly improve treatment outcomes. For example, the combination of carboplatin and paclitaxel has shown better overall response rates in ovarian cancer compared to using either drug alone[3].

Market Analysis

Global Market Size and Growth

The global platinum-based cancer drugs market, which includes PLATINOL, was valued at USD 1,712.73 million in 2024 and is projected to grow to USD 2,733.24 million by 2034, exhibiting a Compound Annual Growth Rate (CAGR) of 4.3% during 2025-2034. This growth is driven by the increasing adoption of combination therapies, the development of new formulations, and the rising emphasis on personalized cancer treatments[3].

Market Segments and Trends

• Combination Therapies: The use of platinum-based drugs in combination with other agents is a major trend. This approach aims to enhance therapeutic outcomes, reduce side effects, and overcome drug resistance.
• New Formulations: There is a focus on developing advanced formulations such as liposomal platinum compounds to minimize side effects and improve patient outcomes. Liposomal cisplatin, for example, has shown promising results in clinical trials by offering enhanced drug stability and reduced side effects[3].
• Personalized Cancer Treatments: There is a growing emphasis on tailoring cancer treatments to individual patient profiles, with platinum drugs being part of personalized regimens based on genetic markers of tumors.
• Ongoing Research and Clinical Trials: Continuous clinical research is exploring new applications and indications for platinum-based drugs, including combination regimens for various cancers beyond their traditional uses[3].

Supply and Demand Dynamics

The global platinum market, which is crucial for the production of PLATINOL and other platinum-based drugs, is expected to face its third consecutive deficit in 2025. Despite a slight increase in supply, the demand for platinum, particularly from the automotive and jewelry sectors, is expected to remain robust. The automotive industry, for instance, is projected to consume 3,245,000 ounces of platinum in 2025, marking an eight-year high[2][5].

Projections and Future Outlook

Market Growth

The platinum-based cancer drugs market is expected to continue growing, driven by the increasing adoption of combination therapies and the development of new formulations. The market is projected to reach USD 2,733.24 million by 2034, with a CAGR of 4.3% during 2025-2034[3].

Expanding Access and Awareness

Companies are focusing on expanding access to these therapies through geographic and therapeutic area diversification. Marketing efforts are concentrated on increasing awareness among healthcare providers and patients, particularly in emerging markets, to improve early cancer detection and treatment adoption. The availability of generic versions of platinum-based drugs is also expected to increase market penetration, especially in cost-sensitive regions[3].

Technological Innovations

The development of targeted delivery systems and new formulations such as liposomal platinum compounds is expected to continue. These innovations aim to improve drug delivery to cancer cells while minimizing damage to healthy tissue, thereby enhancing treatment efficacy and reducing systemic toxicity[3].

Key Takeaways

• Clinical Trials: Recent trials have shown significant improvements in survival rates for advanced bladder cancer using combination therapies involving immunotherapy and antibody-drug conjugates.
• Market Growth: The global platinum-based cancer drugs market is projected to grow to USD 2,733.24 million by 2034, driven by combination therapies and new formulations.
• Supply and Demand: The platinum market is expected to face a third consecutive deficit in 2025, with robust demand from automotive and jewelry sectors.
• Technological Innovations: New formulations and targeted delivery systems are being developed to improve treatment efficacy and reduce side effects.

FAQs

What are the recent clinical trial results for advanced bladder cancer involving platinum-based drugs?

Recent clinical trials, such as the EV-302 trial, have shown that combination therapies involving immunotherapy and antibody-drug conjugates can double survival rates for patients with advanced bladder cancer compared to standard chemotherapy[1].

How is the global platinum-based cancer drugs market expected to grow?

The market is projected to grow from USD 1,792.37 million in 2025 to USD 2,733.24 million by 2034, exhibiting a CAGR of 4.3% during this period[3].

What are the main trends driving the platinum-based cancer drugs market?

Key trends include the increasing adoption of combination therapies, the development of new formulations, and the growing emphasis on personalized cancer treatments[3].

Why is the platinum market facing a deficit in 2025?

The platinum market is facing a deficit due to constrained mine supply despite rising recycling and steady demand. The automotive and jewelry sectors are driving this demand, leading to a projected shortfall of 539,000 ounces in 2025[2][5].

How are new formulations of platinum-based drugs improving treatment outcomes?

New formulations, such as liposomal platinum compounds, are being developed to improve drug delivery to cancer cells while minimizing damage to healthy tissue, thereby enhancing treatment efficacy and reducing systemic toxicity[3].

Sources

1. National Cancer Institute: "Padcev and Keytruda Double Bladder Cancer Survival"
2. CNBC Africa: "Platinum market faces third consecutive deficit in 2025, WPIC says"
3. Polaris Market Research: "Platinum Based Cancer Drugs Market Size - Global Industry Report"
4. FDA: "Platinol (cisplatin) label"
5. Nasdaq: "WPIC: Platinum Market Facing Third Consecutive Deficit in 2025 as Supply Constraints Persist"