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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973309
• Other study ID #: 18R5-002
• Status: Completed
• Phase: Phase 1
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: September 2020
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Vantictumab combined with paclitaxel
Vantictumab combined with paclitaxel will be administered IV.

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Cedars-Sinai Medical Center/ Samuel Oschin Comprehensive Cancer Institute	Los Angeles	California
United States	Texas Oncology-Tyler	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
OncoMed Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer	The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel	Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).
Secondary	Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer	Apparent half life, AUC, clearance, volume of distribution	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.