An Expanded Access Study of Iniparib Combined with Gemcitabine and Carboplatin for the Treatment of Breast Cancer

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 10-003088
    • Jacksonville, Florida: 10-003088
    • Rochester, Minnesota: 10-003088
    NCT ID: NCT01130259
    Sponsor Protocol Number: 2010EAP

About this study

The purpose of this study is to offer pre-approval drug access of iniparib  combined with gemcitabine and carboplatin, in order to provide potential clinical benefit to patients who have ER-, PR-, and HER2-negative metastatic breast cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Histologically documented breast cancer (either primary or metastatic site) that is ER-negative, PR-negative, and HER2 non-over expressing by immunohistochemistry (0, 1) or in situ hybridization (ISH) including; fluorescence (FISH) in situ hybridization / chromogenic in situ hybridization (CISH) with a ratio < 2.0
  • One to three prior chemotherapy regimens in the metastatic setting
    • Prior adjuvant/neoadjuvant therapy is allowed
    • Prior Gemcitabine and/or Platinum agents are allowed
  • Metastatic breast cancer (Stage IV)
  • Female, ≥18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  • Organ and marrow function as follows
    • Absolute neutrophil count (ANC) ≥1500/mm3
    • Platelets ≥100,000/dL
    • Hemoglobin ≥9 g/dL
    • Bilirubin ≤1.5 mg/dL
    • Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60 mL/min
    • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement
  • Females of child bearing potential
    • Documented negative pregnancy test within two weeks of EAP entry
    • Agreement to acceptable birth control during the duration of the EAP therapy
  • Capability to understand and comply with the protocol
  • Signed informed consent document

Exclusion Criteria

  • Systemic anticancer therapy within 14 days of the first dose of study drug
  • Has not recovered to grade ≤1 from adverse events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v3.0, with the exception of alopecia, related to anticancer therapy prior to the first dose of study drug
  • Major medical conditions that might affect EAP participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease)
  • Brain metastases requiring steroids or expected to require other therapeutic intervention during study participation, including WBRT and intrathecal therapy
    • Must be > 21-days from neurosurgical intervention
  • Pregnant or breastfeeding
  • Inability or unwillingness to abide by the EAP protocol or cooperate fully with the investigator or designee
  • Enrollment is limited and will be determined by a validated Random-Selection Process administered by NORD (National Organization of Rare Disorders)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Alvaro Moreno Aspitia, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Alvaro Moreno Aspitia, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Alvaro Moreno Aspitia, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions