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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
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 belowSelect...
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:Select...
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.
Select...
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
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
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
~2320
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Veliparib
2012
Completed Phase 3
~4780
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,919 Total Patients Enrolled
Mark N SteinPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures or currently experience them.It's been over 4 weeks since my last chemo or radiation (6 if I had BCNU or mitomycin C).I am not taking medication that strongly affects certain liver enzymes.I can take care of myself but might not be able to do heavy physical work.My heart's pumping ability is normal or above normal.I have undergone a stem cell transplant for my condition.I am allergic to medications similar to ABT-888 or cyclophosphamide.I have breast cancer with a BRCA mutation, or it's triple-negative.I have had brain metastases treated, haven't used steroids for over 3 months, and have no symptoms.I have received more than 300 mg/m^2 of doxorubicin or a similar drug.My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.I have metastatic breast cancer and am on a 7 or 14-day ABT-888 schedule.I can swallow and retain medication without difficulty.I have non-Hodgkin's lymphoma and am not undergoing stem cell transplant.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I agree to use birth control during the study.My cancer has spread to my brain.My kidney function, measured by creatinine levels, is normal or nearly normal.I am not pregnant and will stop breastfeeding if treated with ABT-888.I have stomach or intestine problems that could affect how I handle or absorb medications.I am not HIV-positive or not on antiretroviral therapy.I have previously received cancer treatment with radioactive drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (veliparib, cyclophosphamide, doxorubicin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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