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Alkylating Agent

Veliparib + Chemotherapy for Advanced Cancer

Phase 1

Waitlist Available

Led By Hussein A Tawbi

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, for which standard curative or palliative measures do not exist or are no longer effective, and for which there is expectation of response to the combination of carboplatin/paclitaxel

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Must not have

Patients with both hepatic and renal dysfunction will also be excluded

Patients who received and progressed on the combination of carboplatin/paclitaxel will not be eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -6 and 3 of course 1 after veliparib dosing

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of veliparib when given with paclitaxel and carboplatin to treat patients with solid tumors that have spread or cannot be removed by surgery and have liver or kidney dysfunction.

Who is the study for?

This trial is for patients with various types of advanced solid tumors that have spread or can't be surgically removed, and who also have liver or kidney dysfunction. They must not have had certain treatments before, should not be pregnant or breastfeeding, and need to use birth control. People with severe allergies to similar drugs, uncontrolled illnesses, a history of seizures, recent chemotherapy/radiotherapy, or HIV on specific therapies cannot join.

What is being tested?

The study is testing the combination of Veliparib with Paclitaxel and Carboplatin in patients with metastatic solid tumors and organ dysfunction. It aims to find the safest dose that can effectively kill tumor cells by blocking enzymes needed for cell growth while stopping them from dividing or spreading.

What are the potential side effects?

Possible side effects include reactions related to immune system suppression such as infection risk increase; blood-related issues like anemia; nerve damage which could cause tingling sensations; allergic reactions; gastrointestinal symptoms like nausea; fatigue due to treatment intensity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have both liver and kidney problems.

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I have not progressed after treatment with carboplatin/paclitaxel.

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My nerve damage does not severely affect my daily activities.

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I have seizures or a history of them.

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I have a bleeding disorder.

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I cannot take pills regularly.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -6 and 3 of course 1 after veliparib dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -6 and 3 of course 1 after veliparib dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -6 and 3 of course 1 after veliparib dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK parameters of veliparib

Secondary study objectives

Incidence of stable disease as assessed by RECIST version 1.1

Incidence of toxicities as assessed by NCI CTCAE v4.0

Response rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

+1 more

Other study objectives

Change in PAR levels

Body Weight Changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (veliparib, paclitaxel, carboplatin)Experimental Treatment5 Interventions

Patients receive veliparib\* PO BID on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 3. Courses repeat every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. NOTE: \* All patients receive a single dose of veliparib PO on day -6 before course 1 (except patients with very severe renal dysfunction who receive veliparib on day -5 or -6 to coincide with a dialysis day).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Veliparib

2012

Completed Phase 3

~4820