Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors

Advanced Cancers Clinical Trial

Official title: A Proof-of-Concept Study for Ilorasertib (ABT-348) Activity in Patients With CDKN2A-Deficient Advanced Solid Cancers: a Phase II Basket Trial

Status Terminated

Clinical Trial Summary

The goal of this clinical research study is to learn if ilorasertib (ABT-348) can help to control CDKN2A-deficient cancer. CDKN2A deficiency is a type of mutation (a genetic change). The safety of this drug will also be studied.

Clinical Trial Description

Study Drug Administration:

Each study cycle is 28 days. You will take ABT-348 by mouth 2 times each day on Days 1, 8, and 15 of each cycle. The first dose you take on these days is called Dose 1, and the second dose you take each day is called Dose 2.

You will take Dose 1 (the earlier dose) of ABT-348 with 4 ounces (about ½ cup) of water. You should fast (not eat or drink anything except water) for 8 hours before taking this dose. You need to fast before this dose because eating food may affect the levels of the study drug that is able to enter your system. You will be allowed to have a light snack 2 hours after Dose 1, and then you may eat anything you like 4 hours after the dose.

You should take Dose 2 (the later dose) as close as possible to 6 hours after the first dose, but not less than 6 hours after the first dose. You do not need to fast before Dose 2. You may eat and drink normally around this dose.

Study Visits:

On Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2:

• You will have a physical exam.

• Blood (about 2 teaspoons) will be drawn for routine tests.

• You will have an EKG (Day 1 of Cycle 2 only). For Cycle 3 and after, you will have these EKGs repeated every 3 cycles (Cycles 6, 9, 12, and so on).

On Day 1 of all cycles, urine will be collected for routine tests.

On Day 1 of Cycles 2 and beyond, if you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.

Every 8 weeks, you will have a chest x-ray, bone scan, MRI/CT or PET/CT to check the status of the disease.

You may be able to have some of these tests/procedures performed at a local lab, clinic, or doctor's office that is closer to your home. The results of these tests will be sent to the study doctor for review. The study doctor or research staff will discuss this option with you in more detail.

Length of Study Drug Administration:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

You participation on this study will be over after your last dose of study drug.

This is an investigational study. ABT-348 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.

Up to 65 participants will be enrolled in this study. All will take part at MD Anderson. ;

Related Conditions & MeSH terms

• Advanced Cancers

• NCT number: NCT02478320
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: August 5, 2016
• Completion date: May 12, 2022