Spots Global Cancer Trial Database for Phase I/Ib Clinical Trial of ABTL0812 in Advanced Cancer Patients

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial