Clinical Trial 19399

Cancer Type:
Interventions:Navicixizumab; OMP-305B83 (Navicixizumab); Taxol (paclitaxel); paclitaxel

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Robert Wenham

Overview

Study Title

A Phase 1b Study of Navicixizumab (OMP-305B83) plus Weekly Paclitaxel in Subjects with Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Summary

The purpose of this study is to test the efficacy and safety of an experimental drug, OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.

Objective

Primary Objective: -To determine the safety of navicixizumab when combined with weekly paclitaxel in subjects with platinum resistant ovarian, primary peritoneal or fallopian tube cancer who have failed >2 prior therapies or received prior bevacizumab. Secondary Objectives: -To determine the preliminary efficacy of navicixizumab when combined with weekly paclitaxel in subjects with platinum resistant ovarian, primary peritoneal or fallopian tube cancer who have failed >2 prior therapies or received prior bevacizumab. . -To determine the rate of immunogenicity of navicixizumab and weekly paclitaxel in subjects with platinum resistant ovarian, primary peritoneal or fallopian tube cancer who have failed >2 prior therapies or received prior bevacizumab. Exploratory Objectives: -To determine the exploratory biomarkers changes of navicixizumab and weekly paclitaxel in subjects with platinum resistant ovarian, primary peritoneal or fallopian tube cancer who have failed >2 prior therapies or received prior bevacizumab.

Inclusion Criteria

  • Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer
  • Measureable disease per response evaluation criteria (RECIST) v1.1
  • Prior bevacizumab
  • Age > or = 21 years
  • Adequate organ and marrow function
  • For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit
  • Ability to understand and the willingness to sign a written informed consent document

  • Exclusion Criteria

  • Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy.
  • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinal obstruction or other known clinically signification gastrointestinal disease
  • Brain metastases
  • Leptomeningial disease or neoplasms in the last 5 years
  • Blood pressure >140/80
  • Significant intercurrent illness that will limit the patient's ability to participate in the study
  • Known metastases that are currently involving the lumen of the gastrointestinal tract
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study
  • Pregnant or nursing women
  • New York Heart Association Classification II, III, or IV
  • Inability to comply with study and follow up procedure