800-872-2273

Clinical Trials and Studies

Your participation matters. Help us discover and cure!

Contact us at (800) USC-CARE (800-872-2273)

We're sorry, but this trial is no longer enrolling volunteers.

3P-13-3: A Phase 1b Dose Escalation Study of OMP-54F28 in Combination with Nab-Paclitaxel and Gemcitabine in Patients with Previously Untreated Stage IV Pancreatic Cancer

Description

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with nab-paclitaxel and gemcitabine. OMP-54F28 is a recombinant fusion binds all Wnt proteins tested and thereby antagonizes Wnt-activated signaling. Recent studies showed that Wnt pathway inhibition by OMP-54F28 was highly effective in combination with gemcitabine plus nab-paclitaxel, quite often leading to tumor regression.Primary Objectives of this study are to evaluate the safety and tolerability of OMP-54F28 in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer and to identify dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose of OMP-54F28 in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer.Study Period will be Approximately 12 to 21 months.OMP-54F28 will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle.Primary efficacy endpoint is objective response, defined as a complete or partial response, on the basis of investigator assessment.

Phase

Phase 1 - a new treatment that has not been tested, and researchers are looking for the best way to administer the treatment and how much can be given safely. Phase I trials are usually offered only to patients with advanced disease who would not be helped by other known treatments. Some patients are helped by these treatments, although in this early stage physicians don’t really know if the treatment will be effective.

Inclusion and Exclusion Criteria

  • Signed Informed Consent Form
  • Age ≥18 years
  • Histologically documented Stage IV ductal adenocarcinoma of the pancreas
  • Availability of FFPE tumor tissue, either archival or obtained at study entry through fresh biopsy
  • Tumor tissue from fine needle aspiration is not acceptable.
  • ECOG performance status of 0 or 1
  • Adequate hematologic and end-organ function
  • Evaluable or measurable disease per RECIST v1.1
  • For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception

  • Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer
  • Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
  • Known hypersensitivity to any component of study treatments
  • Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
  • Leptomeningeal disease as a manifestation of cancer
  • Active infection requiring antibiotics
  • Bisphosphonate therapy for symptomatic hypercalcemia
  • Known history of clinically significant liver disease, including active viral hepatitis and cirrhosis
  • Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
  • Pregnancy, lactation, or breastfeeding
  • Known HIV infection
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Concurrent use of therapeutic warfarin
  • History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis
  • New York Heart Association Classification III or IV
  • Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
  • Osteoporosis based on a T-score of <-2.5 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by DEXA scan
  • Bone metastases and one of the following:
  • Prior history of a pathologic fracture
  • Lytic lesion requiring an impending orthopedic intervention
  • Lack of treatment with a bisphosphonate or denosumab
  • Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos

Sites

  • California

    • USC/Norris Comprehensive Cancer Center, Los Angeles, California, 90033
  • Colorado

    • University of Colorado Hospital Anschutz Cancer Pavilion, Aurora, Colorado, 80045
  • Tennessee

    • Henry-Joyce Cancer Clinic, Nashville, Tennessee, 37232
  • Indiana

    • IU Health University Hospital, Indianapolis, Indiana, 46202
Powered by SC CTSI