Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer (NCT04502602) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer
United States18 participantsStarted 2020-08-24
Plain-language summary
To determine the recommended phase 2 dose (RP2D) of niraparib and neratinib in combination in patients with advanced solid tumors during Phase 1. To evaluate clinical benefit (≥4-month progression-free survival \[PFS\]) of niraparib and neratinib in patients with platinum-resistant ovarian cancer in Phase 1b.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Disease Characteristics
* Phase 1: Patients with advanced solid tumors, excluding primary CNS and prostate tumors, that have progressed during or after treatment with approved therapies or for which there is no standard effective therapy available or
* Phase 1b: Female patients with ovarian cancer who:
* Are platinum resistant (progressed within 6 months of finishing platinum therapy) and
* Have received at least 2 prior lines of therapy and
* Do not have a BRCA germline mutation
* Measurable or evaluable disease by RECIST 1.1
* Age ≥ 18 years
* ECOG performance status 0 or 1
* Adequate bone marrow function as defined below:
* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Platelets ≥ 100,000/mm3 (untransfused)
* Hemoglobin ≥9 g/dL (untransfused)
* Adequate renal function as defined below:
* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) for the laboratory OR calculated
* Or actual creatinine clearance ≥ 30 mL/min (see Appendix 2 for the Cockcroft-Gault formula for calculating creatinine clearance)
* Adequate hepatic function as defined below:
* Total bilirubin ≤ 1.5 x ULN for the laboratory OR direct bilirubin ≤ 1.0 x ULN
* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 3x ULN when liver metastases are present)
* Patients receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy
* Patients must agree not to donate blood during the study or …
What they're measuring
1
Phase 1: To determine the Recommended phase 2 dose (RP2D) of niraparib and neratinib in patients with advanced solid tumors
Timeframe: 4 Months
2
Phase 1b: To evaluate clinical benefit (≥4-month progression-free survival [PFS]) of niraparib and neratinib in patients with platinum-resistant ovarian cancer.