A Phase 1 Dose-Escalation Study in Advanced Solid Tumors, Lymphomas or Multiple Myeloma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
AVEO Pharmaceuticals, Inc.
Study ID
NCT00725634
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • AV-299 — BIOLOGICAL
    AV-299 monotherapy will be given as intravenous infusion in dose-escalation cohorts at 2, 5, 10, and 20 mg/kg. Once the RP2D has been determined the cohort may be expanded to include up to 12 patients for safety assessment and enriched with up to 12 additional Multiple Myeloma patients.
  • AV-299 + erlotinib — BIOLOGICAL
    AV-299 will be given as intravenous infusion at RP2D in combination with erlotinib (150 mg daily). Once the combination-RP2D has been determined the cohort may be expanded to include up to 12 additional patients.

Study Details

Phase 1 study to determine safety, tolerability, dose-limiting toxicities (DLTs), and recommended Phase 2 dose of AV-299 administered IV as monotherapy to patients with relapsed or refractory solid tumors, lymphoma, or multiple myeloma. The study will also determine the safety, tolerability and DLTs of AV-299 in combination with erlotinib in patients with relapsed or refractory solid tumors.

Key Dates

First listed
Jul 30, 2008
Start date
Sep 30, 2008
Status verified
Jan 2014
Primary completion
Dec 31, 2010
Completion
Dec 31, 2013

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AV-299 Dose Escalation Arm
    AV-299 Administered by IV Infusion as Monotherapy in Advanced Solid Tumors, Lymphomas, or Multiple Myeloma
  • Experimental: AV-299 in combination with erlotinib
    AV-299 Administered by IV Infusion in Combination with Erlotinib (150 mg daily) in Advanced Solid Tumors

Primary Outcome Measure

Dose Limiting Toxicity and Recommended Phase 2 dose [ Time Frame: Following 4 weeks of treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Investigational Site 2ScottsdaleArizona--
Investigational Site 3ColumbusOhio--
Investigational Site 1San AntonioTexas--

Find similar trials in Scottsdale, AZ

By condition
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By specialty
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