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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by OncoMed Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01957007
First received: September 27, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 demcizumab 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) ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
    Apparent half life, AUC, clearance, volume of distribution


Estimated Enrollment: 34
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957007

Contacts
Contact: Rainer Brachmann, MD 650-556-6933 rainer.brachmann@oncomed.com

Locations
United States, Colorado
University of Colorado Hospital, Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: David R Camidge, PhD, MRCP    720-848-0449    ross.camidge@ucdenver.edu   
Principal Investigator: David R Camidge, MD, PhD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Grace Dy, MD    716-845-3099      
Principal Investigator: Grace Dy, MD         
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Afshin Dowlati, MD    216-844-3951      
Principal Investigator: Afshin Dowlati, MD         
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01957007     History of Changes
Other Study ID Numbers: 18R5-004
Study First Received: September 27, 2013
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 19, 2014