Phase 2
N=22
Tivantinib in Treating Patients With Recurrent or Metastatic Breast Cancer
Estrogen Receptor Negative · HER2/Neu Negative · Progesterone Receptor Negative · Recurrent Breast Carcinoma · Stage IV Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01575522 ↗Enrolled (actual)
22
Serious AEs
59.1%
Results posted
Mar 2016
Primary outcome: Primary: PFS Status — 1.2 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Tivantinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PFS Status |
1.2 | — |
| SECONDARY Overall Response Using RECIST v1.1 |
4.5 | — |
| SECONDARY To Evaluate c-Met Expression in Archival Tumor Tissue. |
10 | — |
| SECONDARY To Evaluate Phospho c-Met Expression in Archival Tumor Tissue. |
— | — |
| SECONDARY To Evaluate the Incidence of c-Met Positive Circulating Tumor Cells. |
1 | — |
Summary
This phase II trial studies how well tivantinib works in treating patients with recurrent or metastatic breast cancer. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Participants must have histologically or cytologically confirmed invasive breast cancer, with recurrent or metastatic disease; participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
- Participants must have recent evidence of progressive disease
- Participants must have received 1-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days before enrollment in the study
- Participants must have discontinued all biologic therapy (including vaccines) at least 14 days before enrollment in the study
- Participants must have discontinued any investigational therapy at least 14 days before enrollment in the study
- Participants may have received prior radiation therapy in either the metastatic or early-stage setting
- Radiation therapy must be completed at least 14 days before enrollment in the study
- Participant must not have received radiation to > 25% of his or her bone marrow within 30 days of starting study treatment
- Eastern Cooperative Oncology Group (ECOG) performance status = = 60%)
- Hemoglobin >= 9.0 g/dL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin = = 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal
- Either the primary tumor and/or the metastasis must be triple-negative; the invasive tumor must be hormone-receptor poor, defined as estrogen-receptor negative (ER-) and progesterone-receptor negative (PR-), or staining = 2 months after treatment, and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or computed tomography [CT] scan) during the screening period
- Treatment for brain metastases may include whole-brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician
- Participants may be taking anti-convulsant medications, which must be non-enzyme-inducing anti-epileptic drugs
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ARQ 197
- History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as >= grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is permitted)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study
- Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible
Data sourced from ClinicalTrials.gov (NCT01575522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.