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Trial record 2 of 4 for:    OMP-18R5

A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc. Identifier:
First received: September 27, 2013
Last updated: March 9, 2017
Last verified: March 2017
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with docetaxel.

Condition Intervention Phase
Solid Tumors
Drug: Docetaxel
Drug: vantictumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1b Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by OncoMed Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of vantictumab in combination with docetaxel in patients with recurrent or advanced NSCLC. The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly paclitaxel. [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28) ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK) of vantictumab when administered in combination with docetaxel to patients with recurrent or advanced NSCLC [ Time Frame: Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion and before docetaxel infusion from Day 0 to treatment termination ]
    Apparent half life, AUC, clearance, volume of distribution

Estimated Enrollment: 34
Study Start Date: September 2013
Estimated Study Completion Date: May 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel
Drug: Docetaxel - administered intravenously
Drug: Docetaxel
Docetaxel will be administered IV.
Drug: vantictumab
Vantictumab will be administered intravenously
Other Name: (OMP-18R5)
Experimental: vantictumab
Drug: vantictumab - administered intravenously
Drug: Docetaxel
Docetaxel will be administered IV.
Drug: vantictumab
Vantictumab will be administered intravenously
Other Name: (OMP-18R5)

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 docetaxel. Up to approximately 34 patients may be enrolled into the study.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed Informed Consent Form
  • Age ≥18 years
  • Histologically documented recurrent or advanced (Stage IV) NSCLC
  • Eastern CooperativeOncology Group (ECOG) performance status of 0 or 1
  • All acute treatmentrelated 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 and men with partners of childbearing potential, agreement to use two effective forms of contraception

Exclusion Criteria:

  • Prior treatment with docetaxel for recurrent or advanced NSCLC
  • More than two regimens of systemic cytotoxic chemotherapy for recurrent or advanced NSCLC
  • Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment
  • Known hypersensitivity to any component of study treatments
  • Grade ≥ 2 sensory neuropathy
  • Uncontrolled seizure disorder or active neurologic disease
  • Untreated brain metastases
  • 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
  • New York Heart Association Classification III or IV (see Appendix E)
  • 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® (pioglitazone), and Avandia® (rosiglitzone)
  • Active treatment with an oral or IV glucocortocoid for ≥4 weeks at a daily dose equivalent to or greater than 7.5 mg of oral prednisone
  • Fasting β-CTX of >1000 pg/mL
  • Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia
  Contacts and Locations
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Please refer to this study by its identifier: NCT01957007

United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, New York
Roswell Park Cancer Center, Elm & Carlton Streets
Buffalo, New York, United States, 14263
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
  More Information

Responsible Party: OncoMed Pharmaceuticals, Inc. Identifier: NCT01957007     History of Changes
Other Study ID Numbers: 18R5-004
Study First Received: September 27, 2013
Last Updated: March 9, 2017

Keywords provided by OncoMed Pharmaceuticals, Inc.:
Phase 1
dose escalation
histologically confirmed
malignancy metastatic

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017