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
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
Children's Oncology Group	31

Sponsor Type

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

Last updated: July 28, 2026

Paraplatin (Carboplatin) Clinical Trials Update, Market Analysis, and Exclusivity Outlook

Executive summary

• Paraplatin is an international brand of carboplatin used in oncology chemotherapy. Carboplatin is not a single proprietary product with one globally uniform regulatory dossier; exclusivity and patent protection depend on the jurisdiction and specific formulation/manufacturing site.
• Clinical-trial activity is likely concentrated in combination regimens (platinum-backbone strategies) and in biomarker-driven or sequence-optimization studies, rather than in standalone “carboplatin new molecular entity” trials.
• Market position is mature and genericized in most major markets. The principal growth levers are line-of-therapy migration, hospital procurement dynamics, and toxicity-management protocols that preserve platinum use.
• For exclusivity and competitive entry risk, the binding question is whether a specific Paraplatin presentation is protected by composition-of-matter, process, or formulation patents in a given country, and whether any brand-specific Orange Book (US) or national registers still list exclusivity.

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What is Paraplatin (carboplatin) and what product strengths/dosage forms are in use?

Paraplatin is a brand name for carboplatin, a platinum-based cytotoxic agent used across multiple tumor types. Commercial penetration is generally via injectable carboplatin products supplied to hospitals for multi-cycle chemotherapy regimens.

Common clinical use setting

• Platinum partner drug backbone in solid tumors where carboplatin is standard of care.
• Typical administration is IV infusion in multi-week cycles.
• Dosing is frequently calculated using renal function and body metrics (commonly via Calvert formula in clinical practice).

What “Paraplatin” means for IP and regulatory analysis

Because “Paraplatin” is a brand, the relevant exclusivity and patent estate analysis is presentation-specific:

• Drug substance IP: usually long expired for carboplatin historically in many markets.
• Drug product IP: may still exist for certain formulations, stabilization systems, packaging, or manufacturing processes tied to a named manufacturer.
• Market authorization: depends on each jurisdiction’s marketing authorization holder.

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What clinical trials are currently updating carboplatin regimens and how do they affect Paraplatin prospects?

Clinical trial updates for carboplatin products typically track changes in:

• Combination selection (carboplatin + immunotherapy, carboplatin + PARP inhibitors, carboplatin + targeted agents).
• Treatment sequencing (first-line vs maintenance vs salvage).
• Dose and safety management (renal function adjustments, hematologic toxicity mitigation, infusion schedules).

Clinical trial activity patterns that move utilization

1. Platinum with immunotherapy
   • Carboplatin remains a frequent comparator backbone in trials evaluating PD-1/PD-L1 and CTLA-4 combinations in lung and other solid tumors.
2. Platinum with PARP inhibition
   • Carboplatin is used to generate DNA damage responses that are exploited in PARP inhibitor strategies in ovarian, breast, and related settings.
3. Biomarker-driven selection
   • Biomarkers influence whether carboplatin is continued, switched, or reduced, which impacts projected demand for carboplatin suppliers.
4. Less intensive but equivalent efficacy regimens
   • Trials that attempt to reduce toxicity can alter total cumulative carboplatin cycles per patient, affecting market volume even if patient counts stay flat.

What to watch in trial readouts

• Progression-free survival (PFS) and overall survival (OS) endpoints that validate carboplatin continuation.
• Grade 3/4 hematologic toxicity rates, transfusion rates, and discontinuation rates.
• Dose-intensity measures that determine total drug consumption per patient.
• Maintenance eligibility and whether carboplatin is included in maintenance or stops after induction.

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Which therapeutic areas drive carboplatin demand most and where is Paraplatin most exposed?

Carboplatin use is broad, but demand is usually dominated by:

• Lung cancer (including small cell and non-small cell, depending on regimen)
• Gynecologic cancers (notably ovarian)
• Head and neck and other solid tumors where platinum combinations are standard

Demand exposure by regimen type

• First-line induction regimens drive bulk volume.
• Relapse and subsequent lines are smaller volume but higher recurrence-driven variability.
• The largest swing factor for projections is whether clinical practice shifts toward regimens that substitute carboplatin with another platinum (e.g., cisplatin) or toward non-platinum backbones.

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What is the Orange Book status of Paraplatin (carboplatin) in the US?

Carboplatin is widely genericized in the US. Orange Book coverage must be brand-specific and product-specific:

• If Paraplatin is listed, it will show application type (often NDA) and may list patents and/or exclusivity.
• For a genericized active ingredient, many Orange Book entries exist but do not necessarily block generic carboplatin market entries due to expiration of relevant patents or termination of exclusivity.

Practical implication for projections: US market growth is unlikely to be driven by Paraplatin-led exclusivity. It is driven by price and contract dynamics between existing suppliers and new entrants that clear through abbreviated approvals.

(No Orange Book listing details can be asserted here without product-identifier level inputs such as NDA number and submission specifics.)

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When does Paraplatin lose exclusivity and what patent expiration dates matter?

For carboplatin brands, exclusivity is generally constrained by:

• Drug substance composition patents, typically expired long ago for carboplatin globally.
• Drug product patents, which can be more recent and can be jurisdictionally specific.
• Regulatory exclusivity such as 5-year marketing exclusivity, if relevant to a brand’s original approval date, though this is usually not the case for mature carboplatin products.

Patent estate mechanics that control entry

• composition-of-matter blocks generic equivalents only for that specific claim scope.
• formulation/process patents can block “same product” manufacturing.
• method-of-use patents block labeling-based generic indications if they remain unexpired and are carved into the generic ANDA label.

Practical implication: even if drug substance patents expire, Paraplatin may still face entry barriers if a specific presentation is protected by active drug product/process patents in the target jurisdiction.

(No specific expiration dates are provided here because the Paraplatin brand’s jurisdiction, application numbers, and currently asserted patents are not stated.)

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How strong is the patent estate for Paraplatin versus generic carboplatin?

In mature platinum products, the competitive landscape typically looks like:

• Generic carboplatin dominates price and procurement.
• Brand differentiation relies on:
  • validated supply reliability
  • packaging and handling characteristics
  • hospital formulary relationships
  • any still-active patents on product/process or label

What “strong patent estate” means for a carboplatin brand

• Presence of unexpired patents on:
  • specific sterile solution compositions
  • stabilization with defined excipients
  • container-closure components or manufacturing process steps
  • use/sequence claims that map to labeling

What usually weakens estates

• Broad claim interpretation barriers to enforcement.
• Heavy prior art for known excipients and manufacturing methods.
• Generic design-around capability if patents cover narrow process parameters.

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What generic entry risks exist for Paraplatin, including Paragraph IV filings?

For carboplatin brands in the US:

• ANDA filings for carboplatin products often proceed after patent expiration of relevant listed patents.
• If Paraplatin is still covered by Orange Book patents, Paragraph IV challenges are the standard mechanism to accelerate approval.
• The market risk for the brand is the gap between:
  • patent expiry (or court decision)
  • FDA approval date for the first generic
  • actual hospital contracting and switch-over timelines

Practical implication for projections: entry risk is more sensitive to patent litigation outcomes and design-around feasibility than to clinical trial updates.

(No Paragraph IV case list can be stated here without Orange Book patent identifiers and litigation docket details.)

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What patent litigation affects Paraplatin and carboplatin competitors?

Carboplatin litigation, when it occurs, usually includes:

• disputes over listed patents in ANDA contexts (process or formulation claims)
• settlements controlling generic launch timing

Litigation-driven market effects

• Temporary injunctions can delay entry by months to years.
• Settlement-triggered “carve-out” dates can re-align launch windows by dosage strength or formulation.
• Court rulings can create precedent that changes the risk calculus for subsequent ANDAs.

(No specific litigation affecting Paraplatin can be listed without case and jurisdiction inputs.)

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How do clinical trial outcomes for carboplatin combos translate into market demand for Paraplatin?

Market demand for carboplatin is “protocol volume”-driven:

• If trials show improved outcomes using carboplatin in combination and become guideline-changing, carboplatin-treated patient numbers rise.
• If trials reduce platinum exposure (fewer induction cycles or switch to non-platinum strategies), total carboplatin units fall.

Revenue translation channels

• Unit consumption: cycles per patient times strength per cycle.
• Switching risk: procurement switches toward lower-cost generics.
• Tender cycles: can shift demand quickly across suppliers.

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Market analysis: how big is the carboplatin market, and what share is typically capturable by a branded product like Paraplatin?

Branded carboplatin products typically face:

• aggressive generic price compression
• procurement-driven share erosion
• limited promotional leverage once multiple AB-rated generics exist

What determines branded share

• formulary placement and contract terms
• perceived supply assurance
• any product presentation advantages that reduce wastage or handling burden
• local regulatory or tender procurement preferences

Projection framework for Paraplatin

• Base case: market is flat to modestly up in volume, with revenue down due to generic price pressure.
• Upside: local patent/process protection sustains branded pricing in specific geographies or in specific dosage strengths.
• Downside: accelerated generic entry or tender renegotiation forces further price erosion.

(Quantitative market sizing requires external market data inputs not present in the request.)

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Competitive landscape: who supplies carboplatin and how does that shape pricing and distribution?

Carboplatin is supplied by multiple manufacturers across regions. Competition typically manifests through:

• tender pricing
• inventory availability
• cold-chain and packaging logistics
• AB rating equivalence under regulatory frameworks

Pricing dynamics

• Brands usually trade at a premium early; the premium compresses as generics proliferate.
• If Paraplatin retains any exclusivity in a niche region or strength, pricing resilience can last longer than for the overall drug substance.

(Supplier list and market shares cannot be specified without the specific Paraplatin market geography and product authorization details.)

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Regulatory pathway impacts: does Paraplatin face additional approvals, labeling changes, or REMS?

Carboplatin is not associated with REMS broadly; the primary regulatory drivers are:

• label expansions or restrictions based on trial readouts
• manufacturing changes requiring comparability updates
• pharmacovigilance requirements and periodic safety updates

Label-driven market effects

• If carboplatin becomes recommended for new indications or subpopulations, utilization can increase.
• If label tightening reduces eligible patient populations, utilization can decline.

(Specific Paraplatin labeling status cannot be asserted without regulatory jurisdiction and package insert.)

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Key takeaways

• Paraplatin is a carboplatin brand; its clinical-trial relevance is indirect and tied to carboplatin’s role in platinum combination regimens.
• Market outlook is primarily driven by protocol volume and hospital procurement, not by brand-specific innovation.
• Exclusivity and patent protection are jurisdiction- and presentation-dependent; generic entry risk hinges on active product/process or method-of-use patents and any Orange Book-listed patents tied to the specific Paraplatin application.
• Quantitative market sizing, exclusivity timelines, and litigation particulars require product identifiers (NDA/MA number, country, dosage strengths) and Orange Book or national registry patent listings.

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FAQs

1. Do PARP inhibitor plus carboplatin trial results increase carboplatin consumption per patient?
2. Which carboplatin combination regimens are most likely to maintain platinum use in first-line solid tumors?
3. How do hospital tenders typically accelerate switch from branded carboplatin to low-cost generics?
4. What types of carboplatin patents (process vs formulation vs method-of-use) most often delay ANDA entry?
5. How do renal-function dosing protocols (e.g., Calvert formula use) affect total carboplatin units billed and projected revenue?

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References

1. (No sources cited in the absence of Paraplatin-specific regulatory identifiers and accessible trial registry data in the provided prompt.)