NCT01973309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

3.8 years

First QC Date

October 25, 2013

Last Update Submit

September 7, 2020

Conditions

Metastatic Breast Cancer

Keywords

Locally RecurrentMetastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (1)

Vantictumab combined with paclitaxel

EXPERIMENTAL

Drug: vantictumab combined with paclitaxel - administered intravenously

Drug: Vantictumab combined with paclitaxel

Interventions

Vantictumab combined with paclitaxelDRUG

Vantictumab combined with paclitaxel will be administered IV.

Also known as: (OMP-18R5)
Vantictumab combined with paclitaxel

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cedars-Sinai Medical Center/ Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Texas Oncology-Tyler

Tyler, Texas, 75702, United States

Location

Related Publications (1)

  • Diamond JR, Becerra C, Richards D, Mita A, Osborne C, O'Shaughnessy J, Zhang C, Henner R, Kapoun AM, Xu L, Stagg B, Uttamsingh S, Brachmann RK, Farooki A, Mita M. Phase Ib clinical trial of the anti-frizzled antibody vantictumab (OMP-18R5) plus paclitaxel in patients with locally advanced or metastatic HER2-negative breast cancer. Breast Cancer Res Treat. 2020 Nov;184(1):53-62. doi: 10.1007/s10549-020-05817-w. Epub 2020 Aug 14.

    PMID: 32803633DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2013

First Posted

October 31, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

US(4)