To evaluate the efficacy of niraparib in combination with bevacizumab, as assessed by 18-month progression-free survival (PFS) landmark analysis, in patients with Stage IIIB to IV ovarian cancer who have complete response (CR), partial response (PR), or no evidence of disease (NED) following front-line, platinum-based chemotherapy with bevacizumab
Primary Objective:
To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors.
Secondary Objectives:
To establish the pharmacokinetics of orally administered TP-0903
To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment
To study the pharmacodynamics of TP-0903 therapy by:
assessing biomarkers in tumor tissue
assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum
To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
Primary Objective:
Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with
PDR001 (and as single agent if appropriate) in patients with advanced solid tumors.
Secondary Objective:
Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in
combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when
BLZ945 is administered in combination with PDR001.
Determine the safety and tolerability, including Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), and recommended Phase 2 dose (RP2D) of PU-H71 in combination with ruxolitinib in subjects with PMF, post-PV MF, or post-ET MF with residual signs or symptoms of their disease despite at least 6 months treatment with ruxolitinib (Dose
Escalation).
Confirm the safety profile and RP2D of PU-H71 in combination with ruxolitinib in this patient population (Dose Confirmation).
Determine the pharmacokinetics (PK) of PU-H71 in combination with ruxolitinib under the conditions of this study.
Primary Outcome Measures:
The percentage of patients who are alive without disease progression
Assess the percentage of patients without disease progression based on local investigator assessment per RECIST in cohort A and cohort B