CLINICAL TRIALS PROFILE FOR CARBOPLATIN

505(b)(2) Clinical Trials for CARBOPLATIN

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	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	Genentech, Inc.	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
New Combination	NCT00130520 ↗	Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer	Completed	University of Arizona	Phase 2	2005-06-01	The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
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.

All Clinical Trials for CARBOPLATIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001502 ↗	A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors	Completed	National Cancer Institute (NCI)	Phase 1	1996-04-01	The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the maximum tolerated dose of RMP-7 in children with refractory brain tumors.
NCT00002474 ↗	Combination Chemotherapy and Bone Marrow Transplant in Treating Patients With Refractory or Recurrent Ovarian Cancer	Completed	Loyola University	Phase 2	1991-02-01	RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, carboplatin, and mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with autologous bone marrow transplant may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy and autologous bone marrow transplant work in treating patients with refractory or recurrent ovarian cancer.
NCT00002477 ↗	Adjuvant Chemotherapy Compared With Observation in Treating Patients With Resected Early Stage Ovarian Epithelial Cancer	Unknown status	Medical Research Council	Phase 3	1991-04-01	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 cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant therapy using platinum-based chemotherapy drugs with no adjuvant therapy in treating patients with early stage invasive ovarian epithelial cancer.
NCT00002489 ↗	Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	1991-10-01	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: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have non-testicular malignant germ cell tumors.

Clinical Trial Conditions for CARBOPLATIN

Condition Name

Condition Name for CARBOPLATIN
Intervention	Trials
Ovarian Cancer	277
Non-small Cell Lung Cancer	244
Lung Cancer	219
Breast Cancer	197

Condition MeSH

Condition MeSH for CARBOPLATIN
Intervention	Trials
Lung Neoplasms	919
Carcinoma, Non-Small-Cell Lung	893
Ovarian Neoplasms	376
Breast Neoplasms	371

Clinical Trial Locations for CARBOPLATIN

Trials by Country

Trials by Country for CARBOPLATIN
Location	Trials
Japan	965
Canada	932
Italy	847
Spain	801
Australia	637

Trials by US State

Trials by US State for CARBOPLATIN
Location	Trials
California	649
New York	619
Texas	606
Ohio	529
Florida	521

Clinical Trial Progress for CARBOPLATIN

Clinical Trial Phase

Clinical Trial Phase for CARBOPLATIN
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	69
PHASE2	202

Clinical Trial Status

Clinical Trial Status for CARBOPLATIN
Clinical Trial Phase	Trials
Completed	1179
RECRUITING	778
Active, not recruiting	303

Clinical Trial Sponsors for CARBOPLATIN

Sponsor Name

Sponsor Name for CARBOPLATIN
Sponsor	Trials
National Cancer Institute (NCI)	598
AstraZeneca	124
Merck Sharp & Dohme Corp.	118

Sponsor Type

Sponsor Type for CARBOPLATIN
Sponsor	Trials
Other	3369
Industry	1894
NIH	616

Clinical Trials Update, Market Analysis, and Projection for Carboplatin

Last updated: October 28, 2025

Introduction

Carboplatin, a platinum-based chemotherapeutic agent, remains a cornerstone in the treatment of various malignancies, notably ovarian, lung, head and neck, and testicular cancers. As a second-generation platinum compound, carboplatin offers comparable efficacy to cisplatin with a more favorable toxicity profile. This article provides a comprehensive update on clinical trials involving carboplatin, analyzes current market dynamics, and presents future market projections driven by therapeutic advancements and evolving healthcare landscapes.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen a surge in clinical trials exploring carboplatin's therapeutic scope, combination regimens, and novel delivery methods. As of 2023, approximately 150 clinical trials globally focus on carboplatin, with key developments in advanced oncology indications.

Combination Therapies in NSCLC and Ovarian Cancers

Numerous trials evaluate carboplatin in combination with immune checkpoint inhibitors, targeted agents, or emerging therapeutics. Notably:

• Carboplatin and Pembrolizumab in NSCLC: Multiple ongoing Phase III trials (e.g., KEYNOTE series) assess the combination's efficacy and safety in non-small cell lung cancer (NSCLC). Preliminary results indicate improved progression-free survival (PFS) and overall response rates (ORR) compared to monotherapy.
• Carboplatin and Bevacizumab in Ovarian Cancer: Studies continue to refine dosing schedules and patient selection, with some Phase II trials reporting enhanced progression metrics and manageable toxicity.

Innovative Delivery and Reduced Toxicity Strategies

• Nanoparticle formulations: Trials are investigating nanoparticle delivery systems aimed at increasing tumor specificity and minimizing systemic toxicity.
• Biomarker-driven trials: Efforts are underway to identify predictive biomarkers (e.g., BRCA mutations) to optimize carboplatin efficacy.

Clinical Trial Outcomes and Emerging Data

Overall, recent data affirm carboplatin's continued relevance:

• Efficacy: Trials report ORRs ranging from 40-70% depending on tumor type and combination, with acceptable safety profiles.
• Toxicities: Myelosuppression and nephrotoxicity remain primary concerns, though manageable with supportive care.
• Resistance mechanisms: Studies highlight sporadic development of resistance, prompting exploration of combination therapies to circumvent this challenge.

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Market Analysis

Current Market Landscape

Carboplatin's market valuation underscores its enduring significance within oncology therapeutics. According to market research firms, the global carboplatin market was valued at approximately $1.2 billion in 2022, with an anticipated compound annual growth rate (CAGR) of 5-6% through 2030.

Key Market Drivers

• Expanding indications: Beyond ovarian and lung cancers, carboplatin's application is broadening into synergistic combinations for other solid tumors, including head and neck and cervical cancers.
• Improved formulations: Efforts to develop less toxic formulations and novel delivery systems enhance market appeal.
• Emerging healthcare needs: Rising cancer incidences globally, especially in emerging markets, bolster demand.

Market Challenges

• Generic competition: The proliferation of biosimilars and generic formulations has led to pricing pressures.
• Toxicity considerations: The toxicity profile necessitates supportive care measures, impacting overall treatment costs.
• Regulatory dynamics: Stringent approval processes and evolving guidelines influence market access.

Competitive Landscape

Major pharmaceutical players, including Mitsubishi Tanabe Pharma, Sun Pharmaceutical Industries, and Teva, dominate the carboplatin market. These companies focus on manufacturing cost-effective generics and exploring niche formulations.

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Market Projection and Future Outlook

Forecasted Market Growth

The carboplatin market is projected to grow at a CAGR of 5-6% from 2023 to 2030, largely driven by:

• Increased adoption in combination regimens: The integration of immunotherapy enhances carboplatin's usage, particularly in NSCLC and ovarian cancer.
• Expansion into emerging markets: Growing healthcare infrastructure and cancer awareness foster market penetration.
• Innovation in drug delivery: Nanotechnology and biomarker-driven approaches may command premium pricing, elevating market value.

Potential Market Expansion Areas

• Personalized medicine: Biomarker-based patient stratification promises higher efficacy and reduced toxicity, potentially opening new revenue streams.
• New indications: Ongoing trials exploring carboplatin in combination with targeted therapies for broader indications may augment demand.
• Adjunctive supportive care: Modalities improving tolerability could enable broader utilization, especially in vulnerable populations.

Risks and Opportunities

• Market risks: Patent expirations and generic competition threaten profit margins. Additionally, emerging therapies may replace carboplatin in certain indications.
• Opportunities: Strategic collaborations in biomarker research and personalized treatment protocols present significant upside.

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Conclusion

Carboplatin remains a vital component of modern oncology, with ongoing clinical trials substantiating its efficacy, especially in combination regimens involving immunotherapy and targeted agents. The market for carboplatin is poised for steady growth, buoyed by expanding indications, technological innovations, and rising global cancer burdens. Companies focusing on innovative formulations, personalized approaches, and strategic collaborations will likely capitalize on this sustained demand.

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Key Takeaways

• Clinical trial advancements affirm carboplatin’s continued role in combination therapies for solid tumors, particularly NSCLC and ovarian cancer.
• The market size remains robust, valued at approximately $1.2 billion in 2022, with expectations of 5-6% CAGR extending to 2030.
• Emerging innovations in drug delivery and biomarker-guided treatments are poised to enhance efficacy, reduce toxicity, and expand market opportunities.
• Generic competition and biosimilars highlight the need for differentiation through formulation and combination strategies.
• The future outlook hinges on integrating carboplatin into personalized oncology regimens and exploring new therapeutic indications.

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FAQs

1. What are the key advantages of carboplatin over cisplatin?

Carboplatin offers similar efficacy with a more favorable toxicity profile, particularly less nephrotoxicity and neurotoxicity, making it preferable in many clinical scenarios.

2. Are there ongoing trials comparing carboplatin with newer agents?

Yes. Trials are evaluating carboplatin in combination with immunotherapies, targeted agents, and novel formulations to enhance efficacy and safety profiles.

3. What are the main side effects associated with carboplatin?

Myelosuppression, particularly thrombocytopenia, is the most common adverse event, alongside nausea, vomiting, and potential renal toxicity, which can typically be managed with supportive care.

4. How might emerging technologies impact carboplatin’s market share?

Innovations such as nanoparticle delivery and biomarker-guided therapy could improve patient outcomes and pave the way for expanded applications, sustaining or increasing market share.

5. What is the outlook for carboplatin in personalized medicine?

Personalized approaches based on genetic markers like BRCA mutations are expected to optimize patient selection, improve responses, and sustain carboplatin’s relevance in oncology.

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References

1. Global Market Insights. "Cancer therapeutics market size and trends." 2022.
2. ClinicalTrials.gov. Various trials involving carboplatin registered globally.
3. National Cancer Institute. "Carboplatin-related adverse effects." 2022.
4. Pharmaceutical Business Review. "Emerging trends in platinum-based chemotherapies." 2023.
5. MarketsandMarkets. "Oncology drugs market forecast." 2022.