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Research & Clinical Trials > Study Search Tool > A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR)

A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR)

This study is open to:
  • Phase 1 is open to people with: 
    • Solid tumor, advanced or metastatic, which progressed on standard treatment.
    • Patients in Arm B must have a diagnosis of one of the following:
      • triple negative breast cancer
      • urothelial carcinoma
      • ovarian cancer
      • a solid tumor with a deleterious mutation in BRCA1, BRCA2, PALB2, RAD51C or RAD51D
    • Tumor tissue available
  • Phase 2 is open to people with:
    • Confirmed solid tumor, previously treated and measurable, and the following:
      • Participants in arm A must be diagnosed with ovarian cancer without a BRCA mutation 
      • Participants in Arm B must have one of the following cancer types
        • metastatic triple negative breast cancer 
        • advanced/ metastatic urothelial carcinoma
        • relapsed ovarian cancer
      • At least 1 prior line of standard therapy for advanced disease
      • Tumor tissue available
This study is not open to:

For Phase 1, the following exclusions apply:

  • People with a history of a type of bone marrow disorder known as Myelodysplastic Syndromes, or MDS.
  • Symptomatic and/or untreated Central Nervous System (CNS) metastases
  • Exclusion Criteria Phase 2 (both arms):

For Phase 2, the following exclusions apply: 

  • Prior PARP inhibitor treatment allowed for patients with ovarian cancer
  • Known history of MDS
  • Symptomatic and/or untreated Central Nervous System (CNS) metastases
A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR)

A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR)

Clinicaltrials.gov identifier:
NCT03992131

Treatment:
Breast
Ovarian

Study Contact Information

Clovis Oncology Clinical Trial Navigation, phone: 1-855-262-3040 or email    

About the Study

This study will look at how safe, effective and tolerable the oral PARP inhibitor Rucaparib is when used in combination with other anticancer agents in patients with a solid tumor.

Type of Study

This is an open-label study, with two treatment arms. 

  • The study has two arms. This means that patients in the study are placed in one of two different groups.
    • One group will received the PARP inhibitor rucaparib (Rubraca) and a second oral medication called lucitanib.
    • The second group will receive the PARP inhibitor rucaparib and an injectable medication called Sacituzumab govitecan (Troveldy).
  • The study is open-label. All participating patients will know which group they have been assigned to. 

What the Study Entails

Participants will be assigned to one of two groups:

  • Experimental Arm A: Study participants will receive oral Rucaparib (administered twice daily) and oral Lucitanib (administered once daily).
  • Experimental Arm B: Study participants will receive oral Rucaparib (administered twice daily) and IV Sacituzumab Govitecan (administered on days 1 and 8 every 21 days).

Participants in both groups will be followed for up to two years. 

Study Sites

  • Massachusetts
    • Boston: Dana Farber Cancer Institute
    • Contact:  Clovis Oncology Clinical Trial Navigation by phone: 1-855-262-3040 or email    
    • Site PI: Geoffrey Shapiro, MD, PhD      
  • Tennessee
    • Nashville: Sarah Cannon Research Institute
    • Contact:  Clovis Oncology Clinical Trial Navigation by phone: 1-855-262-3040 or email    
    • Site PI: Erika Hamilton, MD   
  • Texas
    • Houston: MD Anderson Cancer Center
    • Contact:  Clovis Oncology Clinical Trial Navigation by phone: 1-855-262-3040 or email    
    • Site PI: Timothy Yap, MBBS, PhD

 

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