Veliparib + Dinaciclib for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+1 other location

Geoffrey Shapiro, MD, PhD - Dana-Farber ...

Overseen byGeoffrey I. Shapiro

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial studies the side effects and the best dose of veliparib and dinaciclib in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment. Veliparib and dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for adults with advanced solid tumors that have spread and are not curable. Participants must have a certain level of blood counts, organ function, and no recent chemotherapy or radiation. They should be able to swallow pills, may have had prior treatments but need to recover from them, agree to use contraception if they can bear children, and provide tissue samples. People with uncontrolled illnesses or who are pregnant/nursing cannot join.

Inclusion Criteria

Absolute neutrophil count >= 1,500/mm^3

I haven't taken any experimental drugs or immunotherapies for the last 3 weeks.

Ability to understand and the willingness to sign a written informed consent document; subjects must be willing to adhere to dose and visit schedules

+18 more

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I am not pregnant or breastfeeding.

I have not had a seizure in the last three months.

+9 more

Participant Groups

The trial is testing the combination of two drugs: Veliparib (ABT-888) and Dinaciclib (SCH727965), which might block enzymes that help tumor cells grow. It's in phase I to find out the safest dose with the least side effects for patients whose cancer has spread widely.

1Treatment groups

Experimental Treatment

Group I: Treatment (veliparib and dinaciclib)Experimental Treatment2 Interventions

PART 1A: Patients receive veliparib PO BID on days 1-28 and dinaciclib IV over 2 hours on days 8 and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PART 1B: Patients receive veliparib and dinaciclib as patients in Part 1A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PART 1C: Patients receive veliparib PO BID on days 1-7 of cycle 0. Patients then receive veliparib PO BID on days 1-21 and dinaciclib IV over 2 hours on days 1, 4, 8, and 11 or days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.