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

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. Note: This study has completed enrollment. 

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

Note: This study has completed enrollment. 

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