Clinical trial NCT01973309: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Keywords: Locally Recurrent
Metastatic Breast Cancer
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
First posted: 2013-10-31
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer
timeFrame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).
Secondary outcomes:
measure: Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer
timeFrame: 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.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center/ Samuel Oschin Comprehensive Cancer Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler
state: Texas
Study officials:
References:
citation: 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.