Spots Global Cancer Trial Database for Phase 1, First-in-human Study of Oral TP-1287 in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Phase 1, First-in-human Study of Oral TP-1287 in Patients With Advanced Solid Tumors

Official Title: A Phase 1, First-in-human, Open-label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-1287 to Patients With Advanced Solid Tumors

Study ID: NCT03604783

Conditions

Advanced Solid Tumors

Sarcoma

Ewing Sarcoma

Dedifferentiated Liposarcoma

Synovial Sarcoma

Interventions

TP-1287

Study Description

Brief Summary: TP-1287 is an oral phosphate prodrug of the CDK9 inhibitor, alvocidib. This is a Phase 1, open-label, dose-escalation, dose-expansion, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-1287 in patients with advanced metastatic or progressive solid tumors who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.

Detailed Description: Primary Objective: * During Dose Escalation: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-1287 in patients with advanced metastatic or progressive solid tumors who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition. * During Dose Escalation: To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-1287 * During Dose Expansion: To evaluate the preliminary antitumor activity of TP-1287 in terms of objective response rate (ORR) when administered at the RP2D in patients with sarcoma subtypes (ie, EWS, DDLPS and SS) * During Dose Expansion: To evaluate the preliminary antitumor activity of TP-1287 in terms of clinical benefit rate (CBR) at week 16 when administered at the RP2D in patients with the defined sarcoma subtypes Secondary Objectives: * During Dose Escalation: To establish the pharmacokinetics of orally administered TP-1287 * During Dose Escalation: To observe patients for any evidence of antitumor activity of TP-1287 by objective radiographic assessment * During Dose Escalation: To study the pharmacodynamics of TP-1287 therapy * During Dose Expansion: To determine the median progression-free survival (PFS) rate in patients with sarcoma * During Dose Expansion: To evaluate the safety of TP-1287 when administered at the RP2D in patients with sarcoma