ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer

Part of paid clinical trials in Melbourne, Florida.

Sponsor
Celgene
Study ID
NCT00394082
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ABI-007 — DRUG
    125 mg/m\^2 of ABI-007 administered by intravenously (IV) over 30 minutes on days 1, 8 and 15 of each 28 day cycle.
  • Bevacizumab — DRUG
    Bevacizumab administered once every 2 weeks (10 mg/kg) by IV infusion after ABI-007 has been given. The first dose is one Day 1, cycle 1.

Study Details

The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab. The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer.

Key Dates

First listed
Oct 31, 2006
Start date
Jun 1, 2006
Status verified
Nov 2019
Primary completion
Sep 1, 2009
Completion
Feb 1, 2011

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ABI-007 plus Bevacizumab
    ABI-007 is administered on days 1, 8 and 15 at 125 mg/m\^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.

Primary Outcome Measure

Participants With At Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: up to 25 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
-MelbourneFlorida32901-
-OcoeeFlorida34761-
-NilesIllinois60714-
-Terre HauteIndiana47802-
-ColumbiaMaryland21044-
-WestministerMaryland21157-
-Saint JosephMissouri64507-
-RochesterNew York14623-
-BedfordTexas76022-
-DallasTexas75246-
-El PasoTexas79915-
-OdessaTexas79761-
-San AntonioTexas78229-
-TylerTexas75702-
-FairfaxVirginia22031-
-NorfolkVirginia23502-
-SalemVirginia24153-
-BurienWashington98166-
-EdmondsWashington98026-
-VancouverWashington98684-

Find similar trials in Melbourne, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health

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