Last updated on December 2018

Study to Evaluate the Safety and Tolerability of IACS-010759 in Subjects With Advanced Solid Tumors and Lymphoma


Brief description of study

This clinical research study has 2 parts: dose escalation and dose expansion.

The goal of dose escalation in this clinical research study is to find the recommended dose of IACS-010759 that can be given to patients with advanced solid tumors or lymphoma.

The goal of dose expansion in this clinical research study is to learn if the dose of IACS-010759 found in the dose escalation part of the study is the best dose to use in future studies using IACS-010759 in patients with advanced solid tumors or lymphoma.

The safety of this drug will also be studied.

This is an investigational study. IACS-010759 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 60 participants will take part in this study. All will be enrolled at MD Anderson.

Detailed Study Description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined the study. Up to 5 groups of 3-6 participants will be enrolled in the dose escalation part of the study. Up to 30 participants will be enrolled in dose expansion.

If you are enrolled in dose escalation, the dose of IACS-010759 you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of IACS-010759. Each new group will receive a higher dose of IACS-010759 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of IACS-010759 is found.

If you are enrolled in the dose expansion part of the study, you will receive the dose level of IACS-010759 that was found to be the best dose in the escalation part of the study.

In the dose expansion part of the study, 3 groups of 10 participants each will be enrolled. Each group will be made up of participants with different disease types (breast cancer, pancreatic cancer, and cancers with tumors that can be safely biopsied on several occasions [the Biopsy Expansion Cohort]).

Study Drug Administration:

Each study cycle is 21 days. You will take the drug in 2 phases: Induction Phase and Maintenance Phase.

In the Induction Phase, you will take IACS-010759 by mouth one (1) time every day on Days 1-7 of Cycle 1. At the end of the Induction Phase, you will move on to the Maintenance Phase.

During the Maintenance Phase, you will take IACS-010759 by mouth twice per week. The study doctor will tell you when to take your dose.

You should take each dose with about a cup (8 ounces) of water and at least 1 hour before or 2 hours after a meal. If you miss a dose, you should not take another dose until the next scheduled time.

Length of Study:

You may continue to take IACS-010759 up to 12 cycles or longer if the study 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. It is possible that you may need to stop taking the study drug for a period of time and then re-start it. The study doctor will tell you if this is the case.

Your participation on this study will be over after long-term follow-up (described below).

Study Visits:

On Day 1 of Cycle 1:

  • You will have a physical exam.
  • Blood (about 7-8 teaspoons each time) will be drawn before and after the dose for acid/base level tests, for PK testing and for PD testing.
  • Blood (up to 2 teaspoons) will be drawn for tumor genetic testing.
  • You will have an EKG before the dose after the dose.

On Days 4, 11, and 18 of Cycle 1, blood (about 1 teaspoons each time) will be collected for acid/base level. Blood (about 1 teaspoon each time) will also be collected for PK testing. On Day 11 and 18, blood for PK testing will be drawn before and 4 hours after your study drug dose.

On Day 7 and 15 of Cycle 1:

  • You will have a physical exam.
  • You will have an EKG. Blood (about 3-4 teaspoons) will be drawn before the dose to check how well your organs function and for routine and acid/base level testing. On Day 7 only, blood (about 1 teaspoon) will also be drawn for acid/base level testing 4 hours after your study drug dose.
  • Blood (about 1 teaspoon each time) will be drawn before the dose and then 5 more times over the next 12 hours on Day 7 and before and after the dose on Day 15 for PK testing.
  • On Day 15 only, blood (about 6 teaspoons) will be drawn for PD testing.
  • Urine will be collected before the dose for routine tests.

On Day 8 of Cycle 1:

  • Blood (about 7 teaspoons) will be drawn for acid/base level and PD testing.
  • Blood (about 1 teaspoon each time) will be drawn before and after the dose for PK testing.
  • If you are in the Biopsy Expansion Cohort, you will also have a tumor biopsy.

On Day 1, 8, and 15 of Cycle 2:

  • You will have a physical exam.
  • Blood (about 7-8 teaspoons each time) will be drawn for routine tests, acid/base level tests, to check how well your organs are functioning, and for PD testing.
  • On Day 1, blood (1 teaspoon each time) will be drawn before and after the dose for PK testing.
  • On Day 15, blood (1 teaspoon each time) will be drawn before the dose and again 6 more times over the next 24 hours for PK testing.
  • Urine will be collected for routine tests.

On Day 21 of Cycle 2:

  • You will have a PET, MRI, CT scan or X-ray.
  • You will have a physical exam.
  • If your doctor decides it is needed, blood (up to 1/2 teaspoon) will be drawn for tumor marker testing.
  • Blood (about 3-4 teaspoons) will be drawn to check how well your organs are functioning and for routine acid/base level and PK testing.
  • Urine will be collected for routine tests.

On Day 21 of Cycles 3 and beyond:

  • You will have a physical exam.
  • Blood (about 3-4 teaspoons) will be drawn to check how well your organs are functioning and for routine acid/base level and PK testing.
  • Urine will be collected for routine tests.

Every 2 cycles while you are on study, you will have blood drawn to test for relevant tumor markers, PD testing and a CT scan performed. After you have received the study drug for 6 months, your doctor may decide that you can have these tests performed once every 3 cycles (instead of every 2 cycles). If you have a response to the study drug, you will have CT scans performed again within 4 weeks.

If the study doctor stops and re-starts your dose of study drug, the following will be

performed

Blood (about 3-4 teaspoons) will be drawn for acid/base level and PK testing. This blood draw will also be used to check how well your organs are functioning.

If the study doctor lowers your dose of study drug, the following will be performed when you start taking the lower dose:

Blood (about 1 teaspoon) will be drawn for PK testing.

End-of-Study Visit:

About 30 days after your last dose of the study drug:

  • You will have a physical exam.
  • You will have a PET, MRI, CT scan or X-ray.
  • Blood (about 9-10 teaspoons) and urine will be collected for routine tests, acid/base level tests, and PK and PD testing. Blood for PK and PD testing may continue to be collected, if possible, every 4 days for up to 4 weeks after your last dose of study drug.
  • If you are in the Biopsy Expansion Cohort, you will have a tumor biopsy.

If you are unable to return to the clinic for the visit, this testing can be performed by a local doctor and the results will be sent to the study doctor. The research nurse will call you to ask about your health. These calls should last about 5 minutes.

Long-Term Follow-Up:

After the End-of-Study visit, you will remain in long-term follow-up until the disease gets worse, you start a new cancer therapy, or up to two years after the last dose of study drug, whichever occurs first. During this time, the study staff will call you every 3-6 months and ask about how you are doing. Each call should last about 5 minutes. If the doctor thinks it is needed, you may be asked to come to the clinic for a physical exam.

Clinical Study Identifier: NCT03291938

Contact Investigators or Research Sites near you

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Recruitment Status: Open


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