Skip to main content
OpenTrials
Completed

NCT Number: NCT01973309

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Cedars-Sinai Medical Center/ Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vantictumab combined with paclitaxel

Drug

Vantictumab combined with paclitaxel will be administered IV.

Other names: (OMP-18R5)

Primary outcomes

  1. 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

  1. Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer

    Time frame: 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.

    Apparent half life, AUC, clearance, volume of distribution

Sponsors and collaborators

Lead sponsor

OncoMed Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2013
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.