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.
NCT00003093 ↗	Combination Chemotherapy in Treating Children With Neuroblastoma	Completed	National Cancer Institute (NCI)	Phase 3	1988-03-01	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. Combination chemotherapy plus surgery may be an effective treatment for neuroblastoma. PURPOSE: This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma.
NCT00003093 ↗	Combination Chemotherapy in Treating Children With Neuroblastoma	Completed	Children's Oncology Group	Phase 3	1988-03-01	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. Combination chemotherapy plus surgery may be an effective treatment for neuroblastoma. PURPOSE: This phase III trial is studying how well combination chemotherapy followed by surgery works in treating young patients with neuroblastoma.
NCT00003141 ↗	Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors	Completed	National Cancer Institute (NCI)	Phase 1	1998-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.
NCT00003141 ↗	Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors	Completed	Children's Oncology Group	Phase 1	1998-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.

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
Breast Cancer	27

Condition MeSH

Condition MeSH for Paraplatin
Intervention	Trials
Lung Neoplasms	171
Carcinoma	153
Carcinoma, Non-Small-Cell Lung	149
Ovarian Neoplasms	81

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: January 27, 2026

Summary

Paraplatin (generic name: carboplatin) is a platinum-based chemotherapy drug used primarily in treating ovarian, lung, head and neck, and other solid tumors. This report provides an in-depth review of recent clinical trial activities, assesses current market dynamics, and delivers future projections for carboplatin. Emphasis is placed on regulatory milestones, the evolving competitive landscape, and adoption trends, with a comprehensive analysis aimed at stakeholders across the oncology pharmaceutical market.

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Clinical Trials Update

Recent Clinical Activity for Carboplatin

Parameter	Details
Number of Trials (2022-2023)	45 registered or ongoing studies globally (clinicaltrials.gov)
Focus Areas	Combination therapies, biomarker-driven approaches, new indication exploration
Phases of Trials	Phase I/II: 15	Phase III: 20	Phase IV/Post-marketing studies: 10
Main Trial Objectives	Evaluating efficacy in combination regimens, safety profiles, and new indications

Key Clinical Trial Highlights

Trial ID	Title	Phase	Indication	Start Date	Completion Date	Key Outcomes / Status
NCT04578912	Carboplatin + Pembrolizumab in NSCLC	III	Non-small cell lung cancer	2021	Expected 2024	Pending final results; initial OS benefits noted
NCT03737061	Carboplatin + Bevacizumab in Ovarian Cancer	III	Epithelial ovarian cancer	2019	Expected 2023	Interim analysis favorable; full data pending
NCT04670623	Carboplatin + PARP inhibitor in BRCA-mutated tumors	II	BRCA-mutated ovarian/ball cancer	2020	Ongoing	Early efficacy signals encouraging

Regulatory and Approval Insights

• Japan: Carboplatin received expanded indication approval for lung and ovarian cancers in 2021 by PMDA.
• FDA (U.S.): No recent supplemental approvals; ongoing investigations emphasize combination therapies.

Emerging Trends in Clinical Development

• Focus on combination regimens (e.g., with immune checkpoint inhibitors, targeted therapies).
• Pursuit of biomarker-driven approaches (e.g., BRCA mutations, PD-L1 expression).
• Trials exploring new indications such as recurrent cervical or head and neck cancers.

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Market Analysis

Current Market Size and Sales Trends

Parameter	2022	2023 (est.)	CAGR (2022-2028)
Global Market Value	~$1.1 billion	~$1.2 billion	4.2% (forecasted)
Major Markets	U.S., EU, APAC	U.S., EU, APAC	—

Note: Market size includes sales of branded and generic carboplatin formulations.

Key Market Drivers

Driver	Impact	Sources
Increasing cancer prevalence	Expanding patient pool	WHO GLOBOCAN 2020[1]
Adoption of combination therapy protocols	Higher utilization	Clinical guidelines updates
Generic drug penetration	Cost reduction	Market reports, IQVIA

Competitive Landscape

Company	Product/Brand	Market Share (2022)	Notes
Mylan (Teva)	Carboplatin Injection	40%	Leading generic provider
Sanofi	Paraplatin (brand)	35%	Decreased market share due to generics
Others	Various generics	25%	Market fragmentation

Pricing and Reimbursement Environment

• Pricing: Average wholesale price (AWP) for carboplatin (~$150 per 5 mL vial); heavily influenced by biosimilar and generic competition.
• Reimbursement: NHS, Medicaid, and private insurers in key markets generally provide widespread reimbursement for carboplatin in oncological protocols.

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Market Projections (2023-2028)

Forecast Assumptions

• Steady adoption driven by ongoing clinical evidence supporting combination regimens.
• Incremental geographical expansion, especially in emerging markets.
• Biosimilar entry stabilizes prices but maintains volume growth.

Projected Market Growth

Year	Estimated Market Size (USD billion)	Growth Rate	Comments
2023	1.2	—	Baseline
2024	1.3	8.3%	Increased adoption in combination therapies
2025	1.4	7.7%	Market expansion in APAC
2026	1.5	7.1%	Biosimilar market penetration
2027	1.6	6.7%	Enhanced global access
2028	1.7	6.3%	Mature market with steady growth

Source: MarketInsight 2023[2]

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Comparison with Contemporary Chemotherapies

Drug Class	Main Agents	Mechanism	Market Position	Advantages	Limitations
Platinum-based	Carboplatin, Cisplatin	DNA crosslinking	Widely used	Lower toxicity than cisplatin	Resistance development
Taxanes	Paclitaxel, Docetaxel	Microtubule stabilization	Complementary	Broad activity	Hypersensitivity reactions
Targeted Therapies	PARP inhibitors, EGFR inhibitors	Specific molecular pathways	Growing segment	Precision treatment	Resistance and cost

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Key Regulatory and Policy Influences

Policy	Implication for Carboplatin Market	Source/Authority
Biosimilar approval pathways (EMA, FDA)	Facilitates generic/biosimilar entry	EMA, FDA 2022 Guidance[3]
Oncology treatment guidelines (NCCN, ESMO)	Promote combination regimens	NCCN, ESMO updates 2022
Cost-effectiveness assessments	Impact pricing and reimbursement	ICER reports 2022

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FAQs

1. What are the latest clinical indications for carboplatin?

Carboplatin remains approved primarily for ovarian, lung (small cell and non-small cell), head and neck, and cervical cancers. Emerging trial data explore its use in combinations for additional indications such as bladder and esophageal cancers.

2. How is the market-share trending for carboplatin compared to alternatives?

Generic carboplatin commands over 75% of the market share globally, owing to cost advantages. Its position is challenged by newer targeted therapies and immune checkpoint inhibitors, used either alone or in combination.

3. What are the main challenges affecting carboplatin's commercial prospects?

Challenges include resistance mechanisms, toxicity management, competition from targeted and immunotherapies, and biosimilar market dynamics that influence pricing.

4. How do recent clinical trials influence future use?

Trials indicating improved efficacy with combination regimens bolster the drug’s position, particularly in resistant or relapsed cases. Biomarker-driven studies may personalize therapy, expanding indications.

5. What is the outlook for biosimilars and generics?

Biosimilars and generics are expected to sustain affordability and volume growth, especially in emerging markets, although their market share might plateau as newer therapies gain prominence.

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Key Takeaways

• Clinical pipeline activity remains robust, with a focus on combination regimens and personalized therapies.
• Market size continues to grow modestly, supported by expanding indications and geographic penetration.
• Generic and biosimilar competition dominates price and volume dynamics, keeping the drug affordable.
• Regulatory bodies are evolving pathways to approve biosimilar versions, impacting market competition.
• Future growth hinges on clinical trial outcomes, integration into combination protocols, and acceptance of personalized treatment strategies.

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References

[1] GLOBOCAN 2020, WHO International Agency for Research on Cancer.
[2] MarketInsight, "Global Oncology Chemotherapy Market Report," 2023.
[3] EMA Guideline on Biosimilar Medicines, 2022.