Clinical Trials Logo

Clinical Trial Summary

Clinical study of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors


Clinical Trial Description

An open label multicentric Phase 1 study of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors.The study will follow an Accelerated Titration Design (ATD) with 100% dose increments until significant toxicity as described below; followed by standard dose titration with 40% dose increments. Dose and schedule (alternate dosing regimen eg. OD, BID, intermittent) will be determined by the dose escalation outlined in the protocol and considering pharmacokinetics of the study drug determined from earlier cohorts. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01762410
Study type Interventional
Source Piramal Enterprises Limited
Contact
Status Suspended
Phase Phase 1
Start date September 2012
Completion date March 2016

See also
  Status Clinical Trial Phase
Terminated NCT03195764 - Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors Phase 1
Completed NCT03349073 - An Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors Phase 1
Recruiting NCT04892498 - Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0) Phase 2
Recruiting NCT05035745 - Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START) Phase 1/Phase 2
Recruiting NCT03863145 - Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors Early Phase 1
Active, not recruiting NCT04685473 - Safety and Tolerability Study for T-1101 (Tosylate) Capsules to Treat Advanced Refractory Solid Tumors Phase 1
Completed NCT04324372 - Clinical Study of HEC68498 in Patients With Advanced Refractory Solid Tumors Phase 1
Recruiting NCT02300467 - NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors Phase 1
Suspended NCT01779336 - Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors Phase 1
Completed NCT04200404 - A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors Phase 1/Phase 2