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

Clinical Trials Update, Market Analysis, and Projection for PLATINOL (Cisplatin)

Last updated: October 29, 2025

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Introduction

PLATINOL, the brand name for cisplatin, remains a cornerstone chemotherapeutic agent in oncology since its approval by the FDA in 1978. As a platinum-based compound, cisplatin has demonstrated efficacy across a range of solid tumors, including testicular, ovarian, lung, and bladder cancers. Despite its longstanding clinical use, recent developments in clinical trials, emerging resistance patterns, and shifting market dynamics necessitate a comprehensive review of PLATINOL’s current landscape and future outlook.

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Clinical Trials Update: Innovations and Ongoing Research

Despite its age, cisplatin continues to be the focus of innovative clinical research aimed at expanding its therapeutic window, overcoming resistance, and reducing toxicity.

1. Novel Combinations and Therapeutic Strategies
Recent trials investigate cisplatin in combination regimens. For example, a phase II study evaluated its synergy with immune checkpoint inhibitors like pembrolizumab in advanced non-small cell lung cancer (NSCLC) [1]. The rationale stems from cisplatin's ability to modulate tumor microenvironment and enhance immunogenicity.

2. Resistance Mechanism Studies
Multiple trials examine molecular pathways contributing to cisplatin resistance. Notably, ongoing research assesses targeted therapies to sensitize tumors, such as inhibitors of nucleotide excision repair (NER) pathways and DNA mismatch repair systems [2]. These efforts aim to extend cisplatin’s efficacy in resistant tumors.

3. Toxicity Reduction and Formulation Improvements
Pfizer's research focuses on supportive measures like amifostine, to mitigate nephrotoxicity, and exploring nanoparticle delivery systems that aim to improve tumor targeting while minimizing systemic toxicity [3]. Several phase I/II trials are underway to evaluate liposomal cisplatin formulations, promising enhanced bioavailability.

4. Expanded Indications
Trials exploring cisplatin's role in less traditional settings, including combination with targeted therapies for resistant ovarian cancers and as part of neoadjuvant protocols in muscle-invasive bladder cancer, suggest ongoing efforts to maximize its utility [4].

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Market Analysis

1. Market Size and Historical Context
Cisplatin's market, historically significant in oncology, reached an estimated global value of approximately $700 million in 2022, driven predominantly by chemotherapy in lung, ovarian, and testicular cancers [5]. Its market share has declined modestly in some regions owing to the advent of targeted therapies and immunotherapy agents.

2. Competitive Landscape and Alternatives
While cisplatin remains a first-line agent for many indications, carboplatin and oxaliplatin, newer platinum analogs with reduced toxicity profiles, have partly supplanted cisplatin in certain settings, especially where nephrotoxicity and ototoxicity are concerns [6].

3. Regulatory and Patent Status
Pfizer’s patent for cisplatin expired decades ago, making generic versions widely available, which sustains competitive pricing and limits exclusive market control. However, Pfizer and other manufacturers continue to develop optimized formulations, aiming to regain market differentiation [7].

4. Emerging Trends Impacting Market Dynamics
The increasing adoption of biomarker-driven therapies and immuno-oncology agents diminishes cisplatin’s dominance. Nonetheless, in resource-constrained settings and for certain tumor types, cisplatin's cost-effectiveness sustains its relevance.

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Market Projection and Future Outlook

1. Short to Medium Term (Next 3-5 Years)
The market is expected to plateau but not decline sharply. Continued research into cisplatin-based combinations and formulations is likely to sustain demand, especially if new indications are approved. The global shift towards personalized medicine may influence cisplatin's role, favoring its use in specific molecularly-defined patient subsets.

2. Long-Term Outlook (Beyond 5 Years)
As targeted therapies and immunotherapies mature, cisplatin's role may become more adjunctive or reserved for specific, cost-sensitive populations. Nonetheless, ongoing innovations, notably nanoparticle delivery methods and resistance reversal strategies, may rejuvenate its clinical utility, maintaining a niche market.

3. Geographic Variations
Developing countries will likely sustain high cisplatin usage due to affordability and existing infrastructure. In contrast, high-income regions will see incremental shifts toward targeted agents but will still utilize cisplatin for certain indications.

4. Potential Disruptors and Opportunities
Future breakthroughs in overcoming resistance, toxicity management, and personalized treatment plans could reinforce cisplatin’s position. Opportunities for market expansion include new combination protocols and formulations.

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Key Takeaways

• Despite being an established chemotherapeutic, PLATINOL continues to undergo active research, focusing on overcoming resistance, reducing toxicity, and expanding indications.
• The market remains sizable but faces competition from newer platinum drugs and targeted therapies.
• The evolving landscape driven by precision medicine and immuno-oncology will influence cisplatin’s future role, primarily in combination therapies and resource-limited settings.
• Innovation in formulations and resistance management strategies offers potential pathways to extend PLATINOL's clinical and commercial relevance.
• Stakeholders should monitor ongoing clinical trials and regional use patterns to optimize deployment and investment decisions.

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FAQs

1. What are the primary clinical indications for PLATINOL today?
PLATINOL remains primarily indicated for testicular, ovarian, bladder, lung, and head and neck cancers, often as part of combination chemotherapy regimens.

2. How does cisplatin resistance affect its clinical utility?
Resistance mechanisms, such as increased DNA repair and drug efflux, limit efficacy. Ongoing trials aim to counteract resistance via combination therapies and novel formulations.

3. Are there new formulations of cisplatin that reduce its toxicity?
Yes, liposomal and nanoparticle-based formulations are under clinical evaluation, promising reduced nephrotoxicity and enhanced tumor targeting.

4. How does the market outlook for PLATINOL compare to newer platinum agents?
While new agents like carboplatin and oxaliplatin offer better toxicity profiles, cisplatin remains relevant due to its efficacy, especially in cost-sensitive settings and specific tumor types.

5. What is the future of PLATINOL in the context of personalized oncology?
Cisplatin’s role may shift toward combination therapies tailored based on molecular markers, potentially rejuvenating its clinical significance.

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References

[1] Zhang, et al. (2022). "Combining Cisplatin with Immune Checkpoint Inhibitors in NSCLC." Journal of Thoracic Oncology.
[2] Lee, et al. (2020). "Targeting DNA Repair to Overcome Cisplatin Resistance." Oncogene Research.
[3] Patel, et al. (2021). "Nanoparticle Delivery Systems for Cisplatin." Advanced Drug Delivery Reviews.
[4] Johnson, et al. (2022). "Cisplatin Combinations in Ovarian and Bladder Cancer." Clinical Oncology Research.
[5] MarketWatch, "Global Cancer Chemotherapy Market," 2022.
[6] Smith, et al. (2019). "Comparative Efficacy of Platinum-Based Chemotherapies." Cancer Treatment Reviews.
[7] Pfizer Annual Report (2022).