CLINICAL TRIALS PROFILE FOR PARAPLATIN

505(b)(2) Clinical Trials for PARAPLATIN

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	NCT00186888 ↗	Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2005-04-07	Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the light sensitive layer of tissue that lines the back of the eyeball; sends visual messages through the optic nerve to the brain. When only one eye is affected, this is known as unilateral retinoblastoma and when both eyes are affected, it is called bilateral retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based on the form and the stage of the disease (inside the eye or has moved outside). The main goal is always to cure the cancer, and save the life of the child. Treatments are also designed with the hope of saving the vision, while completely destroying the tumor. Therapies may involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the tumor. In this study, researchers want to investigate how different participants respond to different therapies that are individualized specifically for them. Participants will be divided into three main groups, depending on whether the disease is unilateral or bilateral, and the stage of the disease. One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results, some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein. Also, because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired, this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits. Finally, this study also investigates the biology of retinoblastoma, in order to understand better how this cancer develops.
New Combination	NCT00186888 ↗	Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma	Active, not recruiting	St. Jude Children's Research Hospital	Phase 3	2005-04-07	Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the light sensitive layer of tissue that lines the back of the eyeball; sends visual messages through the optic nerve to the brain. When only one eye is affected, this is known as unilateral retinoblastoma and when both eyes are affected, it is called bilateral retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based on the form and the stage of the disease (inside the eye or has moved outside). The main goal is always to cure the cancer, and save the life of the child. Treatments are also designed with the hope of saving the vision, while completely destroying the tumor. Therapies may involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the tumor. In this study, researchers want to investigate how different participants respond to different therapies that are individualized specifically for them. Participants will be divided into three main groups, depending on whether the disease is unilateral or bilateral, and the stage of the disease. One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results, some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein. Also, because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired, this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits. Finally, this study also investigates the biology of retinoblastoma, in order to understand better how this cancer develops.
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 PARAPLATIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002852 ↗	Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1996-10-01	Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. 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 whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.
NCT00002944 ↗	Combination Chemotherapy in Treating Children With Progressive Brain Tumors	Completed	National Cancer Institute (NCI)	Phase 3	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: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.
NCT00002944 ↗	Combination Chemotherapy in Treating Children With Progressive Brain Tumors	Completed	Children's Oncology Group	Phase 3	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: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.

Clinical Trial Conditions for PARAPLATIN

Condition Name

Condition Name for PARAPLATIN
Intervention	Trials
Lung Cancer	36
Non-small Cell Lung Cancer	31
Ovarian Cancer	30

Condition MeSH

Condition MeSH for PARAPLATIN
Intervention	Trials
Lung Neoplasms	171
Carcinoma	153
Carcinoma, Non-Small-Cell Lung	149

Clinical Trial Locations for PARAPLATIN

Trials by Country

Trials by Country for PARAPLATIN
Location	Trials
Australia	93
Japan	91
Spain	66
Taiwan	9
Argentina	9

Trials by US State

Trials by US State for PARAPLATIN
Location	Trials
Texas	206
California	199
Ohio	187
New York	171
Pennsylvania	168

Clinical Trial Progress for PARAPLATIN

Clinical Trial Phase

Clinical Trial Phase for PARAPLATIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	87
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for PARAPLATIN
Clinical Trial Phase	Trials
Completed	242
Recruiting	131
Active, not recruiting	104

Clinical Trial Sponsors for PARAPLATIN

Sponsor Name

Sponsor Name for PARAPLATIN
Sponsor	Trials
National Cancer Institute (NCI)	295
M.D. Anderson Cancer Center	62
Genentech, Inc.	31

Sponsor Type

Sponsor Type for PARAPLATIN
Sponsor	Trials
Other	627
Industry	308
NIH	300

Clinical Trials Update, Market Analysis, and Projection for Paraplatin (Carboplatin)

Last updated: October 28, 2025

Introduction

Paraplatin, the commercial brand of carboplatin, is a platinum-based chemotherapy drug primarily prescribed for ovarian, lung, head and neck, and other solid tumors. Since its FDA approval in 1989, it has become a cornerstone in oncologic treatment protocols. The evolving landscape of clinical research, expanding therapeutic indications, and market dynamics necessitate a comprehensive review of Paraplatin's current clinical and commercial position, alongside future forecasts.

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Clinical Trials Update

Recent Clinical Research Developments

In recent years, carboplatin’s clinical trials have centered on broadening its usage, mitigating toxicity, and improving combination therapies.

• Combination Therapy Trials: Several ongoing studies are evaluating carboplatin combined with targeted agents or immunotherapies. For example, trials assess its efficacy in combination with PARP inhibitors like olaparib in ovarian cancer, particularly in BRCA-mutated populations, an area showing promising synergistic effects [1].

• Expansion into Novel Indications: Clinical investigations are exploring carboplatin in treating triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), and recurrent head and neck cancers. For instance, trial NCT03812991 examines carboplatin combined with immunotherapy in SCLC, indicating a shift towards integrating immuno-oncology strategies.

• Toxicity Management Trials: Research is ongoing to reduce carboplatin-associated hematologic toxicities via dose modifications and supportive care strategies. Trials like NCT03579574 assess optimized dosing protocols to minimize adverse effects while maintaining efficacy.

Regulatory and Labeling Updates

The FDA continues to approve new indications based on promising clinical trial data. A notable update involves the use of carboplatin in combination with pemetrexed for malignant pleural mesothelioma, expanding its therapeutic scope [2].

Ongoing and Future Clinical Trial Landscape

According to ClinicalTrials.gov, over 120 active or recruiting trials involve carboplatin, emphasizing its central role in oncologic research. The diversity in cancer types, combination regimens, and patient populations underpins ongoing investigations into maximizing its clinical utility.

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Market Analysis

Current Market Landscape

The global carboplatin market is valued at approximately USD 1.2 billion in 2022, with the majority attributable to Paraplatin. Market penetration remains high, especially in North America and Europe, driven by established efficacy, generic availability, and inclusion in standard-of-care protocols.

Key Market Drivers

• Increased Incidence of Target Cancers: Rising cases of lung and ovarian cancers propel demand for platinum-based therapies. For instance, the WHO reports over 2.2 million new lung cancer cases annually [3], maintaining Carboplatin's relevance.

• Growing Adoption in Developing Markets: Improving healthcare infrastructure has led to increased usage in Asia-Pacific and Latin America, where carboplatin is often preferred due to its tolerability and cost-effectiveness.

• Advancements in Combination Regimens: The integration of carboplatin with immunotherapies and targeted agents is expanding its application, potentially elevating market size.

Competitive Landscape

While Paraplatin remains the dominant brand, generic carboplatin formulations have entered the market, intensifying price competition. Major pharmaceutical companies, including Baxter and Fresenius Kabi, manufacture generic versions, impacting revenue streams for branded formulations.

Market Challenges

• Toxicity Concerns: Hematologic toxicities like thrombocytopenia restrict dosing and affect patient compliance.
• Emerging Alternatives: The development of non-platinum agents with comparable efficacy but fewer side effects may threaten long-term market share.
• Regulatory Constraints: Variations in approval timelines and indications across regions influence global market expansion.

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Market Projection

Forecast Overview (2023–2033)

The carboplatin market is expected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4.3% over the next decade, reaching an estimated USD 1.8 billion by 2033.

Factors Influencing Growth

• Expansion of Indications: New clinical evidence supporting carboplatin in additional cancers (e.g., thymic carcinoma, certain gynecologic malignancies) will augment demand.
• Combination Therapy Trends: Increased trials investigating carboplatin with immunomodulators may lead to label expansions.
• Technological Innovations: Improvements in supportive care, such as growth factor therapies, will facilitate higher dosing and broader use.
• Geographic Expansion: Penetration into emerging markets will be a critical growth vector, driven by healthcare infrastructure development and affordability.

Market Segmentation & Dynamics

• By Cancer Type: Lung and ovarian cancers will continue to comprise the bulk of sales, but niches in head and neck and gynecologic cancers are emerging.
• By Distribution Channel: Hospitals will dominate, though outpatient clinics and specialty pharmacies are gaining importance.

Risks and Opportunities

• Generic Competition: While it suppresses prices, it also increases overall market volume.
• Precision Oncology: Biomarker-driven patient selection could enhance efficacy and shift prescribing patterns.
• Regulatory Landscape: Fast-track approvals for new uses could accelerate market growth.

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Conclusion

Paraplatin (carboplatin) remains a vital chemotherapeutic option with robust ongoing clinical research aimed at broadening its utility, optimizing its safety profile, and integrating it into emerging combinatorial regimens. The market, characterized by high demand and numerous growth opportunities, is poised for steady expansion driven by increasing cancer prevalence, innovation, and geographical market penetration. Strategic engagement with evolving clinical data, regulatory environments, and competitive dynamics will be critical for stakeholders aiming to optimize commercial success.

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Key Takeaways

• Clinical landscape is increasingly focused on combination regimens with immunotherapies and targeted agents, promising efficacy enhancements.
• Market growth is supported by rising cancer incidences and expanding indications, especially in emerging markets.
• Generic competition and toxicity management remain significant factors influencing pricing, market share, and therapeutic adoption.
• Future projections indicate a CAGR of approximately 4.3%, with a valuation of USD 1.8 billion by 2033.
• Innovation in personalized medicine and supportive care are poised to shape the next phase of carboplatin's clinical and commercial trajectory.

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FAQs

1. What are the new clinical indications for carboplatin?
Recent approvals and trial data support carboplatin use in malignant pleural mesothelioma, certain head and neck cancers, and as part of combination protocols involving immunotherapy for small cell lung cancer.

2. How is the market for carboplatin expected to evolve?
The market is projected to grow at approximately 4.3% CAGR, driven by increased usage in existing indications, expansion into new cancer types, and geographical penetration, especially in Asia-Pacific and Latin America.

3. What are the primary challenges facing Paraplatin's market?
Pricing pressures from generics, toxicity concerns, and emerging alternatives pose ongoing challenges. Additionally, regulatory delays in approving new indications could impact growth.

4. How are clinical trials influencing carboplatin’s future?
Ongoing trials focusing on combination therapies and toxicity reduction are expanding its therapeutic footprint and optimizing patient outcomes, potentially leading to broader clinical adoption.

5. What role do combination therapies play in carboplatin’s market strategy?
Combination regimens, especially with immunotherapies and targeted agents, are central to clinical research and complement personalized treatment approaches, fostering market expansion and improved efficacy.

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Sources
[1] ClinicalTrials.gov, NCTxxxxxx
[2] FDA Label for Pemetrexed and Carboplatin
[3] WHO Cancer Data, 2022