PARP Inhibitor (Niraparib) in Patients with Inherited or Tumor PALB2 Mutations in Advanced Solid Tumors (PAVO)
Clinicaltrials.gov identifier:
NCT05169437
Treatment
Any advanced or metastatic solid tumor except ovarian or prostate
Study Contact Information:
Study Contact Information:
[email protected]
PARP Inhibitor (Niraparib) in Patients with Inherited or Tumor PALB2 Mutations in Advanced Solid Tumors (PAVO)
About the Study
PAVO is an Phase II study investigating if the study drug, a called (), is safe and effective for certain people who have been diagnosed with an advanced solid tumor with either an inherited or tumor mutation.
All participants will receive the study drug, . Study participants will be dosed with orally once daily throughout each 28-day cycle and be evaluated via CT or scans every 8 weeks for approximately one year. Participants will have the opportunity to report patient-reported outcomes (PROs) while on study treatment at the scan intervals.
Study Locations
For a list of study sites enrolling patients, see clinicaltrials.gov.
Lead Researchers/Study PIs and Affiliation
Inclusion criteria:
- Positive test for a pathogenic gene mutation (inherited or tumor)
- Provide archival tissue representative of current tumor status
- Received all standard therapies appropriate for their tumor type and of disease or, in the opinion of the Investigator, the participant would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or has no satisfactory alternative treatments.
People with the following are not eligible to participate
- Ovarian or cancer
- Inherited or tumor or mutations
- Received prior PARP inhibitor(s) in prior lines of treatment
- Relapsed while receiving platinum based therapy in the adjuvant/curative setting
- Progressed within 14-18 weeks while receiving platinum based therapy in the setting