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

Phase 1

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Vantictumab combined with paclitaxel

• Registration Number: NCT01973309
• Lead Sponsor: OncoMed Pharmaceuticals, Inc.

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vantictumab combined with paclitaxel	Vantictumab combined with paclitaxel	Drug: vantictumab combined with paclitaxel - administered intravenously

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer	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 Outcome Measures

Name	Time	Method
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.	Apparent half life, AUC, clearance, volume of distribution

Trial Locations

Locations (4)

Texas Oncology-Baylor Charles A. Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

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

Texas Oncology-Tyler; 🇺🇸 Tyler, Texas, United States