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
Breast Neoplasms	81

Clinical Trial Locations for PARAPLATIN

Trials by Country

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

PARAPLATIN Market Analysis and Financial Projection

Last updated: April 28, 2026

Paraplatin: Clinical Trials Update and Market Outlook

What is Paraplatin and what products are competing?

Paraplatin is a brand name for carboplatin (a platinum-based chemotherapy agent). Carboplatin sits in the same therapeutic and purchasing category as other platinum and platinum-adjacent oncology drugs used across gynecologic and other solid tumors.

Competitive set (therapeutic substitutes at the regimen level):

• Cisplatin (including branded and generic cisplatin products)
• Oxaliplatin (L-OHP, including branded and generic oxaliplatin products)
• Platinum combination regimens anchored by carboplatin (with partner drugs such as paclitaxel, docetaxel, gemcitabine, bevacizumab depending on tumor and line of therapy)

Market implication: Carboplatin is predominantly a cost-and-availability category. In mature markets, the main market-shaping variables are generic penetration, tender pricing, and reimbursement, not clinical differentiation alone.

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What is the latest clinical-trials picture for Paraplatin (carboplatin)?

A complete “clinical trials update” for the specific branded product Paraplatin requires traceable, brand-specific entries (identifier, sponsor labeling, and study registry linkage). No such brand-specific, current-period registry and publication data was provided in the input, and producing a “complete and accurate response” without it would introduce incorrect trial attribution.

Operationally, carboplatin’s clinical-development universe is large but mostly covers:

• New combination regimens (partner drugs)
• New schedules/dosing strategies
• Pharmacokinetic and population analyses
• Comparative effectiveness in specific histologies and lines of therapy

Market and R&D planning point: For carboplatin, brand-level trial reporting typically does not create a new commercial thesis unless tied to:

• A distinct formulation with regulatory differentiation,
• A novel biomarker-defined indication that changes use patterns, or
• A label expansion tied to an identifiable product.

With no provided brand-linked trial dataset, the only accurate stance is that a brand-specific clinical update cannot be compiled from the information available.

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What does the current market look like for carboplatin/Paraplatin?

Carboplatin is used widely in:

• Ovarian cancer (including epithelial ovarian cancer and platinum-sensitive or platinum-resistant contexts)
• Lung cancers (most notably small-cell and non-small-cell settings through standard chemotherapy pathways, depending on guideline position and line)
• Bladder and other solid tumors where platinum chemotherapy is used

Demand drivers:

• Incidence and treatment rates in tumors where platinum regimens remain standard
• Uptake of platinum combinations with guideline-based partner drugs
• Tender-driven prescribing in hospital systems
• Generic pricing cycles and availability

Structural market drivers for branded carboplatin exposure:

• Generic competition tends to compress branded net prices quickly.
• The brand position often depends on:
  • Supply continuity
  • Formulation differentiation (if any)
  • Institutional procurement contracts

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What market projections are defensible for Paraplatin over the next 3 to 5 years?

Without validated, cited inputs (current sales base, geography, channel split, forecast methodology, and brand-level regulatory status), a credible projection cannot be constructed to the required standard.

However, directional expectations for carboplatin category economics are consistent across mature markets:

• Unit demand tends to follow oncology incidence and guideline-driven use of platinum chemotherapy.
• Revenue growth is typically constrained by generic substitution and ongoing price pressure.
• Value preservation relies on contract wins, supply strength, and any formulation or procurement advantages.

A defensible projection would require brand-level baseline revenue and ownership of distribution channels by geography, which is not present in the input.

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Regulatory and label position: why it matters for market timing

A meaningful market forecast for Paraplatin hinges on whether the product has:

• Active indications that remain guideline-relevant
• Current regulatory status (approvals, renewals)
• Formulation specifics that impact substitution (e.g., concentration, packaging, administration attributes)

No Paraplatin-specific regulatory dossier details were provided, so a label-based market timing analysis cannot be produced.

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Actionable business view: where value is likely created in this category

Even without brand-specific trial updates, decision-makers can frame Paraplatin/carbo-platin strategy around known levers:

1) Contracting and tender economics

• Track hospital group tenders and national procurement price ceilings
• Model substitution risk by tender award rules (brand vs generic equivalence)

2) Supply continuity

• Platinum drugs are sensitive to manufacturing and logistics constraints
• Contract duration and fill-rate performance often dominate purchasing decisions

3) Regimen placement

• Carboplatin value is tied to whether guideline sequences still anchor regimens in targeted histologies and lines
• Monitor guideline revisions driven by partner-drug entrants (not carboplatin itself)

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Key Takeaways

• Paraplatin is carboplatin, a mature platinum chemotherapy category shaped more by generic pricing, procurement, and supply than by brand-specific innovation.
• A brand-specific clinical trials update and labeled market forecast cannot be compiled from the provided information without accurate brand-linked trial and regulatory/financial inputs.
• For market work, the highest-yield levers are tender contracting, supply continuity, and regimen placement driven by oncology guideline cycles and partner drug uptake.

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FAQs

1) Is Paraplatin the same as carboplatin?

Yes. Paraplatin is a brand name for carboplatin.

2) Why do clinical trial updates often matter less for carboplatin brands than for novel oncology drugs?

Carboplatin is widely used as a platform chemotherapy backbone; most “newness” tends to appear in combination regimens and partner drugs, which can shift demand without changing carboplatin itself.

3) What drives pricing for Paraplatin/carbo-platin in mature markets?

Generic substitution and hospital or national procurement tenders typically set pricing more than trial results.

4) What would most likely improve Paraplatin’s market position?

Any differentiation that resists substitution (formulation, packaging, or regulatory label expansion tied to a distinct clinical niche) plus durable contracting.

5) What is the best way to forecast Paraplatin’s revenue?

Use a geography-by-geography model tied to tender pricing, generic mix, historical utilization by indication, and procurement contract terms.

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References

No sources were provided in the input, and no brand-specific or current clinical-trials and market data can be cited to meet the citation requirement.