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Alkylating agent

Veliparib + Chemotherapy for Advanced Lymphoma

Phase 1

Waitlist Available

Led By Mark N Stein

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

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with either solid tumors or non-Hodgkin's lymphoma are eligible

Must not have

Patients with active seizure or a history of active seizure

Patients receiving strong inhibitors or inducers of specific cytochrome P450 enzymes are prohibited

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, course 1 to day 1, course 2

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dosage of a combination of veliparib, cyclophosphamide, and doxorubicin hydrochloride to treat patients with solid tumors or non-Hodgkin lymphoma that has spread or can't be removed by surgery.

Who is the study for?

This trial is for patients with metastatic or unresectable solid tumors or non-Hodgkin lymphoma. Eligible participants must have a life expectancy over 2 months, adequate organ function, and no recent chemotherapy or radiation. They should not be on certain drugs affecting liver enzymes and agree to use contraception. Those with HIV, active infections, heart failure, CNS metastases, or severe allergies to the study drugs are excluded.

What is being tested?

The trial tests the combination of Veliparib with Cyclophosphamide and Doxorubicin Hydrochloride in treating advanced cancers. It aims to find the safest doses while assessing how these drugs affect cancer growth by blocking cell division and spreading.

What are the potential side effects?

Potential side effects include nausea, fatigue, hair loss from Doxorubicin; low blood counts from Cyclophosphamide; and gastrointestinal issues from Veliparib. There may also be risks of infection due to immune system suppression caused by chemotherapy.

Eligibility Criteria

Inclusion Criteria

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

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

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

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I have metastatic breast cancer and am on a 7 or 14-day ABT-888 schedule.

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My kidney function, measured by creatinine levels, is normal or nearly normal.

Exclusion Criteria

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

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I have a history of seizures or currently experience them.

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I am not taking medication that strongly affects certain liver enzymes.

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I have undergone a stem cell transplant for my condition.

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I am allergic to medications similar to ABT-888 or cyclophosphamide.

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I have received more than 300 mg/m^2 of doxorubicin or a similar drug.

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

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I can swallow and retain medication without difficulty.

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My cancer has spread to my brain.

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I am not pregnant and will stop breastfeeding if treated with ABT-888.

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I am not HIV-positive or not on antiretroviral therapy.

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I have previously received cancer treatment with radioactive drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, course 1 to day 1, course 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, course 1 to day 1, course 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, course 1 to day 1, course 2 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

MTD, defined as the dose level that no more than 2/6 or 1/3 patients experience DLT and at least 2/3 or 3/6 patients treated with next higher dose level will have had DLT

Secondary study objectives

Change in pharmacokinetic parameters

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, cyclophosphamide, doxorubicin)Experimental Treatment5 Interventions

GROUP I: Patients receive veliparib PO every 12 hours on days 1-4 and cyclophosphamide IV over 60 minutes on day 3. GROUP II: Patients receive veliparib PO every 12 hours on days 1-4, cyclophosphamide IV over 60 minutes on day 3, and doxorubicin hydrochloride IV over 15 minutes on day 3. GROUP III: Patients receive veliparib PO every 12 hours on days 1-7, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride IV over 15 minutes on day 1. GROUP IV: Patients receive veliparib PO every 12 hours on days 1-14, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride over 15 minutes on day 1. In all groups, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860