NCT03366480

A Study to Assess the Efficacy and Safety of ABTL0812

A Phase I/II, Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Paclitaxel and Carboplatin in Patients With Advanced Endometrial Cancer or Squamous NSCLC

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Ability Pharmaceuticals SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC.

Detailed description

This is a phase I/II multicenter divided in two phases. Phase I: Safety and dose escalation This study is not randomized, and all included patients will receive ABTL0812 in addition to paclitaxel + carboplatin (SOC). In this phase, patients can be selected from both indications, regardless of the number of each indication. This phase will be divided in 2 periods: Period 1: A dose de-escalation phase will be performed with a 3 + 3 design, in which up to four different ABTL0812 dose levels will be tested in combination with SOC. Then, 12 patients will be included in an expansion phase. All patients will receive one week of ABTL0812 alone followed by ABTL0812 + SOC (up to 8 SOC cycles) as combined treatment. Period 2: After the finalization of the SOC cycles, ABTL0812 will be taken as single therapy, at 1300 mg tid, up to 12 months from initiation of period 1. This is the Recommended Phase 2 Dose (RP2D) as monotherapy for ABTL0812 determined in the previous phase I clinical trial. Phase II: Efficacy and safety This phase of the study will include up to 33 patients per indication (up to 66 patients overall). The final number will depend on the number of patients included in the phase I. The number of patients selected per indication will depend on the number already selected in phase I, as it is necessary to compensate both indications to have a final number of 40 patients per indication approximately.

Conditions

• Endometrial Cancer
• Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	ABTL0812 in combination with paclitaxel and carboplatin	ABTL0812 in combination with paclitaxel and carboplatin.

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-06-01
• Completion: 2020-11-15
• First posted: 2017-12-08
• Last updated: 2023-02-22

Locations

1 site across 1 country: Spain