NCT01477489

Brief Summary

The purpose of this study is to determine the maximum tolerated dose of veliparib that can be given while a patient is receiving radiation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2012

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

November 18, 2011

Last Update Submit

December 13, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose of veliparib that can be administered concurrently with standard doses of radiotherapy to the chest wall and regional nodes.

    12-24 months

Secondary Outcomes (1)

  • To describe the nature of toxicity that develops when PARP inhibitors are administered concurrently with chest wall radiotherapy.

    12-24 months

Study Arms (1)

Treatment

EXPERIMENTAL
Drug: VeliparibRadiation: Standard radiation treatment

Interventions

VeliparibDRUG

Starting dose of veliparib will be 50 mg taken twice daily and will escalate up to a possible 200 mg twice daily.

Treatment
Standard radiation treatmentRADIATION

Limited to 60 Gy.

Treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed breast cancer with either a) locoregional recurrence after previous mastectomy or b) inflammatory breast cancer status post mastectomy for which radiotherapy to the chest wall and regional nodes is planned as part of treatment. Patients with Stage IV disease are eligible as long as they meet these criteria.
  • Surgical resection of disease and willingness to wait at least three weeks after surgery to begin radiotherapy.
  • Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies (including trastuzumab) at least two weeks prior to start of radiotherapy.
  • Age \>18 years.
  • ECOG performance status \<2 (Karnofsky \>60%, see Appendix A).
  • Life expectancy of greater than 6 months.
  • Adequate hematologic, renal and hepatic function (assessed within the two weeks prior to registration and within the month prior to the commencement of protocol treatment).
  • Negative pregnancy test (within two weeks prior to registration) if woman has child-bearing potential (defined as not having undergone surgical methods of sterilization and having had menses within the past year).
  • Ability to swallow and retain oral medications.
  • Willingness to undergo the three required skin punch biopsies for research purposes.
  • Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Radiation therapy: Prior history of radiation therapy to the chest wall and/or regional nodes is not allowed (but prior radiation therapy to other sites is permissible).
  • Breast reconstruction: Patients who have undergone breast reconstruction procedures after mastectomy are excluded because of concerns about additional toxicity in this patient population.
  • Gross residual tumor or positive microscopic margins: Patients with gross residual tumor or positive microscopic margins will not be eligible because radiation dose in this study will be limited to 60Gy.
  • Ongoing therapy with other investigational agents: Patients may not be receiving any other investigational agents.
  • Unresolved toxicity from other agents: Patients with unresolved or unstable, CTCAE v4 Grade 3 or greater toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment are not eligible.
  • Significant comorbidity: Also ineligible are patients with clinically significant and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to: active uncontrolled infection; symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; any other illness condition(s) that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit compliance with study requirements.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib.
  • Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of any associated acute toxicities, except that endocrine therapies and bisphosphonates are permitted without restriction even during protocol treatment.
  • Pregnant women are excluded from this study because radiation therapy has teratogenic and abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with veliparib, breastfeeding should be discontinued before the patient receives veliparib.
  • Patients with active seizure disorder or history of seizure, as well as patients with CNS metastases (unless CNS metastases have been stable after therapy for \>3 months and the patient is not on steroids at the time of study enrollment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke

Durham, North Carolina, 27710, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Jagsi R, Griffith KA, Bellon JR, Woodward WA, Horton JK, Ho A, Feng FY, Speers C, Overmoyer B, Sabel M, Schott AF, Pierce L; Translational Breast Cancer Research Consortium. Concurrent Veliparib With Chest Wall and Nodal Radiotherapy in Patients With Inflammatory or Locoregionally Recurrent Breast Cancer: The TBCRC 024 Phase I Multicenter Study. J Clin Oncol. 2018 May 1;36(13):1317-1322. doi: 10.1200/JCO.2017.77.2665. Epub 2018 Mar 20.

    PMID: 29558281DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

veliparib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Reshma Jagsi, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 22, 2011

Study Start

January 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2017

Last Updated

December 15, 2017

Record last verified: 2017-12

Locations

US(5)