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Phase 1, First-in-human Study of Oral TP-1287 in Patients with Advanced Solid Tumors

NCT03604783 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TP-1287

TP-1287 by oral administration

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-26
Primary Completion
2024-01-10
Completion
2024-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604783 on ClinicalTrials.gov