NCT01445522

ABT-888 Plus Metronomic Cyclophosphamide to Treat Cancer

Completed Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing ABT-888 in Neoplasms in 35 participants. Completed in 3 July 2012.

Timeline

3 December 2008

Primary endpoint
3 July 2012

3 July 2012

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	3 December 2008
Primary completion	3 July 2012
Estimated completion	3 July 2012
Sites	2 locations across United States

Drugs / interventions tested

• ABT-888 — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Neoplasms — all drugs for Neoplasms →
• Lymphoma — all drugs for Lymphoma →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 110, any sex, with Neoplasms or Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting DNA damage response in cancer therapy.
   Hosoya N, Miyagawa K. · · 2014 · cited 232× · PMID 24484288 · DOI 10.1111/cas.12366
2. PARP inhibitors in the management of breast cancer: current data and future prospects.
   Livraghi L, Garber JE. · · 2015 · cited 188× · PMID 26268938 · DOI 10.1186/s12916-015-0425-1
3. Targeting the DNA damage response in hematological malignancies.
   De Mel S, Lee AR, Tan JHI, Tan RZY, et al · · 2024 · cited 4× · PMID 38347838 · DOI 10.3389/fonc.2024.1307839
4. Poly (ADP-Ribose) Polymerase 1 and 2 in B-Cell Lymphoma: Pathogenic Roles and Therapeutic Implications.
   Molina-Alvarez A, Sanchez-Gonzalez B, Colomo L, Yélamos J. · · 2025 · PMID 40713977 · DOI 10.1016/j.ajpath.2025.07.004