A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer

OncoMed Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Metastatic Breast Cancer

Treatments

Drug: Vantictumab combined with paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01973309

18R5-002

Details and patient eligibility

About

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with paclitaxel.

Full 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.

Enrollment

37 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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