MedTrace Logo

ABT-888 Plus Metronomic Cyclophosphamide to Treat Cancer

NCT01445522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

* Cyclophosphamide (CP) is a drug approved by the Food and Drug Administration for the treatment of certain cancers. It works by causing DNA damage, resulting in cell death, including cancer cells.
* ABT-888 is an experimental drug that has been given to a small number of patients. It works by preventing DNA repair in tumor cells.

Objectives:

* To test the safety of the combination of ABT-888 and CP, and to determine the dose of each drug that can be given together to patients with cancer.
* To see how the body handles ABT-888 when given together with CP
* To evaluate the anti-tumor response of the drug combination.

Eligibility:

* Adults with solid tumors or lymphoid cancers (lymphoma and chronic lymphocytic leukemia) whose disease does not respond to standard treatments.

Design:

* Patients take ABT-888 by mouth once a day for 7, 14 or 21 days, depending on the dose level assigned to the individual patient.
* Patients take CP by mouth once a day every day in 21-day cycles. (Some patients take CP for 14 days only.)
* Patients undergo tests and procedures periodically during the study, including:
* Clinic visit and physical examination at the beginning of each cycle
* Blood and urine tests, electrocardiogram, measurement of vital signs
* CT scans, MRI scans or ultrasound tests to check the response of the tumor to treatment
* Tumor biopsies (optional)
* Bone marrow aspiration and biopsy

Conditions

Interventions

DRUG

ABT-888

DRUG

Cyclophosphamide

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Shivaani Kummar, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-03
Primary Completion
2012-07-03
Completion
2012-07-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01445522 on ClinicalTrials.gov