NCT02201823

Phase I/Ib Clinical Trial of ABTL0812 in Advanced Cancer Patients

A PHASE I/Ib, FIRST IN HUMAN, DOSE-ESCALATION STUDY OF ABTL0812 IN PATIENTS WITH ADVANCED SOLID TUMOURS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Ability Pharmaceuticals SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ability Pharmaceuticals promotes a clinical trial to determine the adequate dose of a new drug, ABTL0812, that will be administered orally daily to patients with advanced solid tumors.

Detailed description

This is a phase I/Ib, unicenter, open-label and single-agent study. This study consists of two different parts, a dose escalation phase and an extension phase in patients with advanced solid tumors. ABTL0812 will be administered orally, daily, for 28 days (considered cycle 1). First endpoint is to determine the Maximum Tolerated Dose (MTD). MTD is defined as the highest dose at which no more than one in six patients experiences a ABTL0812 related Dose-Limiting Toxicity (DLT). DLT will be evaluated during the first treatment cycle. Dose escalation phase will be performed with an accelerated design of 3 + 3 Once the 28 days cycle has finished, patients may continue receiving ABTL0812 on a daily continuous schedule if the patient is deemed to have clinical benefit from treatment, according to the treating physician. Treatment will continue until disease progression, onset of unacceptable drug toxicities, or patient/physician's request to discontinue.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	ABTL0812	ABTL0812. Five cohorts and one extension phase.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2014-07-28
• Last updated: 2015-07-02

Locations

1 site across 1 country: Spain