A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label

Part of paid clinical trials in Fresno, California.

Sponsor
AVEO Pharmaceuticals, Inc.
Study ID
NCT02318368
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ficlatuzumab — DRUG
  • Erlotinib — DRUG
  • placebo — DRUG

Study Details

Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Key Dates

First listed
Dec 17, 2014
Start date
Nov 30, 2014
Status verified
Oct 2020
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017

Study Design

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

Arms

  • Experimental: Ficlatuzumab plus erlotinib
    150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
  • Active Comparator: Placebo plus erlotinib
    150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Approximately 24 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
UCSF FresnoFresnoCalifornia93701-
Torrance Memorial Medical CenterRedondo BeachCalifornia90277-
Boca Raton Regional Hospital Lynn Cancer InstituteBoca RatonFlorida33486-
University of Miami Sylvester Comprehensive Cancer Center Deerfield BeachDeerfield BeachFlorida33442-
Kaiser Permanente HawaiiHonoluluHawaii96819-
Cancer Center of AcadianaLafayetteLouisiana70503-
Mayo ClinicRochesterMinnesota55905-
Valley Medical GroupParamusNew Jersey07652-
Queens Hospital Cancer CenterJamaicaNew York11432-
Aultman HospitalCantonOhio44710-
Gabrail Cancer CenterCantonOhio44718-
UPMC Cancer Center CancerPittsburghPennsylvania15232-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Fresno, CA

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