The primary objective of the study is:
To evaluate the effect of the addition of navitoclax to ruxolitinib on spleen volume
The secondary objectives of the study are:
To assess the effect of the addition of navitoclax to ruxolitinib on total symptom score (TSS) as assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0 diary
To evaluate the effect of the addition of navitoclax to ruxolitinib on bone marrow fibrosis
To determine the overall response rate (ORR = sum of rates of complete remission [CR] +
partial remission [PR]) associated with the addition of navitoclax to ruxolitinib
To determine the rate of anemia response associated with the addition of navitoclax to
To describe the safety profile and PK profile observed with the addition of navitoclax to
The response rate will be estimated as the percent of eligible and evaluable responders (CR/CRi). A one-sided lower 95% Agresti-Coull confidence limit will be calculated.
The primary objective of this study is:
to evaluate the efficacy and safety of luspatercept for the treatment of anemia in subjects
with MPN-associated myelofibrosis with and without RBC-transfusion dependence.
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.
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