CLINICAL TRIALS PROFILE FOR RUBRACA

All Clinical Trials for RUBRACA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02740712 ↗	Pharmacokinetic Drug-Drug Interaction Study of Rucaparib	Completed	Clovis Oncology, Inc.	Phase 1	2016-04-01	The purpose of this study is to assess pharmacokinetic concentrations of multiple probes alone followed by assessment of the same drug pharmacokinetic concentrations when the patient has steady-state exposure to rucaparib followed by cycle-by-cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation.
NCT02855944 ↗	ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients	Active, not recruiting	Foundation Medicine	Phase 3	2017-03-01	The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.
NCT02855944 ↗	ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients	Active, not recruiting	Clovis Oncology, Inc.	Phase 3	2017-03-01	The purpose of this study is to determine how patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib versus chemotherapy.
NCT02873962 ↗	A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib	Recruiting	Bristol-Myers Squibb	Phase 2	2016-11-10	This research study is evaluating three drugs called Nivolumab, Bevacizumab, and Rucaparib as a possible treatment for relapsed Relapsed Ovarian, Fallopian Tube Or Peritoneal Cancer.
NCT02873962 ↗	A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib	Recruiting	Dana-Farber Cancer Institute	Phase 2	2016-11-10	This research study is evaluating three drugs called Nivolumab, Bevacizumab, and Rucaparib as a possible treatment for relapsed Relapsed Ovarian, Fallopian Tube Or Peritoneal Cancer.
NCT02925234 ↗	The Drug Rediscovery Protocol (DRUP Trial)	Recruiting	Amgen	Phase 2	2016-08-01	This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.
NCT02925234 ↗	The Drug Rediscovery Protocol (DRUP Trial)	Recruiting	AstraZeneca	Phase 2	2016-08-01	This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.

Clinical Trial Conditions for RUBRACA

Condition Name

Condition Name for RUBRACA
Intervention	Trials
Fallopian Tube Cancer	5
Epithelial Ovarian Cancer	4
Ovarian Cancer	4
Solid Tumor	3

Condition MeSH

Condition MeSH for RUBRACA
Intervention	Trials
Fallopian Tube Neoplasms	6
Ovarian Neoplasms	6
Carcinoma, Ovarian Epithelial	4
Prostatic Neoplasms	4

Clinical Trial Locations for RUBRACA

Trials by Country

Trials by Country for RUBRACA
Location	Trials
United States	93
Canada	16
Japan	15
Brazil	12
United Kingdom	11

Trials by US State

Trials by US State for RUBRACA
Location	Trials
California	6
Georgia	5
New York	5
Florida	4
Pennsylvania	4

Clinical Trial Progress for RUBRACA

Clinical Trial Phase

Clinical Trial Phase for RUBRACA
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	8
Phase 1/Phase 2	3

Clinical Trial Status

Clinical Trial Status for RUBRACA
Clinical Trial Phase	Trials
Active, not recruiting	7
Recruiting	7
Completed	5

Clinical Trial Sponsors for RUBRACA

Sponsor Name

Sponsor Name for RUBRACA
Sponsor	Trials
Clovis Oncology, Inc.	19
Bristol-Myers Squibb	6
Foundation Medicine	3

Sponsor Type

Sponsor Type for RUBRACA
Sponsor	Trials
Industry	45
Other	13
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Rubraca (Rucaparib)

Last updated: October 28, 2025

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Introduction

Rubraca (rucaparib) is a groundbreaking PARP inhibitor developed by Clovis Oncology, primarily approved for treating ovarian and prostate cancers characterized by BRCA mutations. Since its initial FDA approval in 2016 for ovarian cancer, Rubraca has garnered interest for expanding indications and evolving through ongoing clinical trials. This report offers a detailed review of recent clinical developments, market dynamics, and future projections to inform stakeholders about Rubraca's current standing and growth potential.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Rubraca continues to be evaluated within a robust pipeline targeting various cancers. Key clinical trials include:

• ARIEL4 (NCT03775850): A Phase III trial evaluating rucaparib maintenance therapy in patients with recurrent ovarian cancer following platinum-based chemotherapy. Results, published in 2022, demonstrated improved progression-free survival (PFS), reinforcing its clinical efficacy.

• TRITON3 (NCT02987543): Focused on metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene mutations. Preliminary data showed significant PSA response rates, supporting Rubraca’s potential for prostate cancer indications.

• TRITON2 (NCT02987543): Enrolled men with mCRPC harboring BRCA mutations. Results indicated an objective response rate (ORR) exceeding 50%, prompting regulatory considerations for broader approval in prostate cancer.

• ATLAS (NCT04171700): A Phase II study assessing rucaparib monotherapy in various solid tumors with homologous recombination deficiency (HRD).

• Combination Trials: Multiple active trials are assessing Rubraca with immuno-oncology agents, such as pembrolizumab, reflecting trends towards combination therapy to enhance efficacy.

Regulatory and Approval Activities

Clovis has expanded Rubraca’s approved indications based on trial outcomes:

• US FDA: Approved for ovarian cancer (maintenance setting), prostate cancer (mCRPC with homologous recombination repair gene mutations), and, more recently, for advanced fallopian tube or primary peritoneal cancer following platinum therapy.

• EU and Other Jurisdictions: Regulatory reviews are ongoing for additional indications, especially in prostate and breast cancers, with several filings submitted based on compelling clinical data.

Emerging Data and Future Directions

Data suggesting efficacy in tumors with HRD beyond BRCA mutations, including tumors with other genomic instability markers, continue to support trial expansion. Moreover, biomarker-driven approaches are shaping clinical strategies, aiming to identify patients most likely to benefit from Rubraca.

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Market Analysis

Current Market Landscape

Rubraca operates in an evolving oncology market characterized by transformative targeted therapies and intensifying competition:

• Ovarian Cancer Market: Estimated to reach $3 billion globally in 2023, with PARP inhibitors claiming a significant share. Key competitors include Lynparza (olaparib, AstraZeneca), Zejula (niraparib, GlaxoSmithKline), and Talzenna (talazoparib).

• Prostate Cancer Market: Significantly expanding, with PARP inhibitors anticipated to reach $1.2 billion globally by 2025. Rubraca's entry into this space is strategic, targeting patients with HRR mutations.

• Market Share: Clovis Oncology's market penetration remains modest relative to competitors but is likely to expand given recent label expansions and data backing.

Competitive Positioning

Rubraca distinguishes itself with:

• Distinct Indications: Approved for both ovarian and prostate cancers, providing diversification.

• Biomarker-Driven Approvals: Tailored for patients with BRCA mutations, aligning with personalized medicine endpoints.

• Orphan Status: Offering niche advantages, including orphan drug exclusivity in certain jurisdictions.

However, competitors' broader indications and established market presence pose substantial challenges. The success of Rubraca relies on strategic marketing, real-world evidence generation, and regulatory milestones.

Market Drivers and Barriers

Drivers:

• Increasing prevalence of ovarian and prostate cancers.
• Growing adoption of precision oncology.
• Positive clinical trial results validating efficacy.

Barriers:

• Pricing pressures and reimbursement hurdles.
• Competition from other PARP inhibitors with broader label approvals.
• Need for robust biomarker testing infrastructure.

Future Market Projections

Based on current trends, the global PARP inhibitor market overall is projected to grow at a CAGR of approximately 17%, reaching over $10 billion by 2030. Rubraca's share is poised to increase favorably if ongoing trials confirm efficacy across broader indications and biomarker-defined populations.

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Strategic Outlook and Growth Projections

Short-term (1–3 years)

• Expansion of approval for prostate cancer patients with HRR mutations will drive sales.
• Continued demonstration of efficacy in comparator and combination trials will enhance therapeutic positioning.
• Market adoption will hinge on successful reimbursement negotiations and clinician awareness campaigns.

Mid-term (4–7 years)

• Potential approval in additional indications such as breast cancer with homologous recombination deficiency.
• Integration into combination regimens with immunotherapies.
• Expansion into emerging markets with growing cancer burdens.

Long-term (8+ years)

• Rubraca may maintain a niche presence in genetically defined cancers.
• Opportunities for lifecycle management include new formulations or combination protocols.
• Competition and patent expiry may influence market share, emphasizing the need for ongoing innovation.

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Conclusion

Rubraca's clinical development trajectory showcases significant progress driven by positive trial data, especially in ovarian and prostate cancers with HRR mutations. Market expansion is supported by increasing adoption of targeted therapies aligned with biomarker-driven treatment paradigms. While competition from larger players remains fierce, strategic focus on expanding indications and combination therapies positions Rubraca for sustained growth.

Effective market penetration will depend on regulatory successes, real-world evidence, and value-based pricing strategies. Stakeholders should monitor ongoing clinical trials and evolving regulatory landscapes to optimize investment and commercialization opportunities.

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Key Takeaways

• Clinical Progress: Rubraca shows promising efficacy in multiple cancers, with key Phase III trials reinforcing its therapeutic role in ovarian and prostate cancers.

• Market Positioning: Positioned as a precision medicine with approved indications, but faces intense competition from other PARP inhibitors like Lynparza and Zejula.

• Growth Potential: Future approvals, expanded indications, and combination strategies could significantly enhance market share, especially if biomarker-driven approaches prove successful.

• Challenges: Market access, reimbursement, and competitive pressure remain critical hurdles requiring strategic planning.

• Investment Implication: Companies and investors should consider Rubraca's evolving clinical pipeline and expanding indications as potential growth catalysts, balanced against competitive and regulatory risks.

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FAQs

Q1: What are the primary indications for Rubraca currently approved by regulators?
A1: The FDA has approved Rubraca for ovarian cancer (maintenance therapy after response to platinum-based chemotherapy), metastatic castration-resistant prostate cancer with BRCA or other HRR mutations, and certain fallopian tube or primary peritoneal cancers.

Q2: How does Rubraca's efficacy compare to its competitors?
A2: Clinical trials show comparable efficacy in genetically defined patient populations. Its advantage lies in approved indications targeting specific mutations, though overall market share remains to be solidified against dominant competitors like Lynparza.

Q3: What are the major ongoing clinical trials for Rubraca?
A3: Notable trials include ARIEL4 (ovarian cancer), TRITON3 (prostate cancer), and combination studies with immunotherapies, aiming to expand its therapeutic utility.

Q4: What are the key factors influencing Rubraca's market growth?
A4: Regulatory approvals in new indications, accumulation of supportive clinical evidence, reimbursement landscape, and competitive positioning are crucial factors.

Q5: What is the outlook for Rubraca in the next five years?
A5: Anticipated expansion into additional indications, potential in combination regimens, and increased adoption in biomarker-selected populations suggest positive growth, contingent upon successful clinical and regulatory milestones.

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References

1. [1] Clovis Oncology. Rubraca (rucaparib) prescribing information.
2. [2] MarketWatch. PARP Inhibitors Market Size, Share & Trends Analysis.
3. [3] FDA Approvals and Label Expansions.
4. [4] ClinicalTrials.gov entries for Rubraca.
5. [5] Global Oncology Market Forecasts.