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

This study is currently recruiting participants.
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

September 27, 2013
October 10, 2013
September 2013
September 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01957007 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC
A Phase 1b Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with docetaxel.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
  • Drug: Docetaxel
    Docetaxel will be administered IV.
  • Drug: vantictumab
    Vantictumab will be administered intravenously
    Other Name: (OMP-18R5)
  • Experimental: Docetaxel
    Drug: Docetaxel - administered intravenously
    Interventions:
    • Drug: Docetaxel
    • Drug: vantictumab
  • Experimental: vantictumab
    Drug: vantictumab - administered intravenously
    Interventions:
    • Drug: Docetaxel
    • Drug: vantictumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
December 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Rainer Brachmann, MD 650-556-6933 rainer.brachmann@oncomed.com
United States
 
NCT01957007
18R5-004
No
OncoMed Pharmaceuticals, Inc.
OncoMed Pharmaceuticals, Inc.
Not Provided
Not Provided
OncoMed Pharmaceuticals, Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP