Clinical Trials /

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

NCT01973309

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

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

  • ORG STUDY ID: 18R5-002
  • NCT ID: NCT01973309

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
Vantictumab combined with paclitaxel(OMP-18R5)Vantictumab combined with paclitaxel

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Vantictumab combined with paclitaxelExperimentalDrug: vantictumab combined with paclitaxel - administered intravenously
  • Vantictumab combined with paclitaxel

Eligibility Criteria

        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
      
Maximum Eligible Age:90 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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).
Safety Issue:
Description:The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel

Secondary Outcome Measures

Measure: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.
Safety Issue:
Description:Apparent half life, AUC, clearance, volume of distribution

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:OncoMed Pharmaceuticals, Inc.

Trial Keywords

  • Locally Recurrent
  • Metastatic Breast Cancer

Last Updated

January 22, 2018