A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 4
- Primary Endpoint
- Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer
Study Overview
Brief Summary
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with paclitaxel.
Detailed Description
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with paclitaxel. Up to approximately 34 patients may be enrolled into the study.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed Informed Consent Form
- •Age ≥18 years
- •Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease
- •o Patients with breast cancer overexpressing HER2 are not eligible.
- •Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •All acute treatment-related toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry
- •Adequate hematologic and end-organ function
- •Evaluable or measurable disease per RECIST v1.1
- •For women of childbearing potential, agreement to use two effective forms of contraception
Exclusion Criteria
- •Known significant dose delays during prior treatment with a taxane due to drug-related toxicities
- •Prior treatment with more than two regimens of systemic cytotoxic chemotherapy for locally recurrent or metastatic disease
- •Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
Arms & Interventions
Vantictumab combined with paclitaxel
Drug: vantictumab combined with paclitaxel - administered intravenously
Intervention: Vantictumab combined with paclitaxel (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer
Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).
The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel
Secondary Outcomes
- Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer(Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion on Days 0, 14, 56 and 70 and at the end of the vantictumab infusion with paclitaxel infusion on Days 0 and 56.)