A Phase I/II Study of Tivozanib and Erlotinib as Initial Treatment for Metastatic Non-small Cell Lung Cancer Assigned by VeriStrat® Serum Proteomic Evaluation

Sponsor
University of Utah
Study ID
NCT01728181
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tivozanib — DRUG
    The phase I study will test two dose levels of tivozanib (dose level 1: 1.0 mg and dose level 2: 1.5 mg) given daily for 3 consecutive weeks followed by one week break. Based on the phase I results, the dose of tivozanib will be chosen for the phase II study.
  • Erlotinib — DRUG
    150 mg/day for 28 day cycle. No rest period.
  • Standard of Care treatment — OTHER
    This treatment will be determined by the study doctor and is considered standard of care.

Study Details

The current trial "A Phase I/II study of Erlotinib +/- Tivozanib as initial treatment for Metastatic Non-small Cell Lung Cancer assigned by VeriStrat® Serum Proteomic Evaluation" will begin by evaluating toxicity for the combination of Tivozanib and Erlotinib to determine a phase II dose. The phase II portion of the study will seek to duplicate the finding of the BEER trial in a selected population of patients with NSCLC with a VeriStrat® Good signature using two oral agents with Tivozanib substituted for bevacizumab. Phase II will be designed as a selection-based randomized trial. Patients with VeriStrat® Good signature will be assigned to EGFR inhibitor therapy with a randomization to Erlotinib plus/minus Tivozanib. Patients with VeriStrat® Poor signature will be assigned to standard of care. Standard-of-care chemotherapy as first treatment at the discretion of patient and physician will be evaluated for response to treatment, survival and repeat VeriStrat® signature.

Key Dates

First listed
Nov 16, 2012
Start date
Nov 30, 2013
Status verified
Jul 2013
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I
    Will receive Tivozanib and Erlotinib treatment.
  • Other: Phase II Group 1 (Standard of Care)
    Group 1: VeriStrat® predicts the chance of no benefit from erlotinib • The patient will get standard-of- care
  • Active Comparator: Phase II Group 2 (arm 1)
    Group 2: VeriStrat® predicts the chance of benefit from Erlotinib • Arm 1: Patient will get the study drugs Erlotinib and Tivozanib
  • Placebo Comparator: Phase II Group 2 (arm 2)
    Group 2: VeriStrat® predicts the chance of benefit from Erlotinib • Arm 2: Patient will get the study drug erlotinib and placebo

Primary Outcome Measure

Safety of combination tivozanib and erlotinib [ Time Frame: 36 months ]

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