A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone as First-line Treatment in Subjects With Locally Recurrent or Metastatic Breast Cancer
18 Years
N/A
Female
Metastatic Breast Cancer
Trial Information
A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone as First-line Treatment in Subjects With Locally Recurrent or Metastatic Breast Cancer
Only the open-label lead-in portion of the study was enrolled (n=10). The randomized portion
was not initiated. N = approximately 102 (90 randomized in a 1:1 ratio in Phase 2,
approximately 6-12 enrolled in open-label lead-in to assess the tolerability of the
combination) Phase 2, randomized, placebo-controlled, double-blind, multi-center study of
the efficacy and tolerability of the ABT-869 + paclitaxel versus placebo for ABT-869 +
paclitaxel in subjects with documented metastatic breast cancer in the first line metastatic
therapy setting. An initial open-label, lead-in cohort of six subjects will be monitored for
2 cycles (8 weeks) to assess the PK interactions and the safety of the combination of 0.20
mg/kg QD ABT-869 and paclitaxel (90 mg/m2). Enrollment into the randomized portion will
begin after a cohort has completed two cycles (8 weeks) of therapy and no toxicities
prohibit the cohort from continuing on to Cycle 3. Alternative doses may be explored based
on the tolerability of the combination.
Inclusion Criteria:
- Subject must be female and > 18 years of age.
- Subject must be diagnosed with adenocarcinoma of the breast.
- Subject must have metastatic disease or locally recurrent disease that is not
amenable to surgical resection with curative intent.
- No prior chemotherapy for locally recurrent or metastatic breast cancer.
- At least 12 months since prior adjuvant or neoadjuvant chemotherapy (including prior
taxane therapy and prior anti-angiogenic therapy [i.e. bevacizumab or a TKI]).
- No HER-2 -over-expression (3+) breast cancer (unless treated with trastuzumab or
lapatinib).
- Subject has measurable disease by RECIST criteria (randomized portion only).
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
- Subject must have adequate bone marrow, renal and hepatic function.
- Subject must have PTT < 1.5 x ULN and INR < 1.5.
Exclusion Criteria:
- Subject has received anti-cancer therapy (other than chemotherapy) including
investigational agents, or biologic therapy within 21 days or within a period defined
by 5 half lives, whichever is shorter, prior to Study Day 1.
- Subject has not recovered to less than or equal to grade 1 clinically significant
adverse effects/toxicities of the previous therapy.
- Subject has received radiation therapy within 14 days of Study Day 1.
- Subject has received anti-cancer hormonal therapy within 14 days of Study Day 1.
- Subject has undergone major surgery within 21 days of Study Day 1.
- The subject has untreated brain or meningeal metastases.
- Subject is receiving therapeutic anticoagulation therapy.
- Subject has a history of or currently exhibits clinically significant cancer related
events of bleeding (e.g., hemoptysis).
- Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.
- Subject has a history of myocardial infarction, stroke, or transient ischemic attack
(TIA) within 6 months of study day 1.
- Subject has a documented left ventricular (LV) ejection fraction < 50%
- Subject has known autoimmune disease with renal involvement.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
Radiographic evaluation every 3 months, clincial evaluation monthly
Safety Issue:
No
Principal Investigator
Justin L. Ricker, MD
Investigator Role:
Study Director
Investigator Affiliation:
AbbVie
Authority:
United States: Food and Drug Administration
Study ID:
M10-265
NCT ID:
NCT00645177
Start Date:
July 2008
Completion Date:
December 2009
Related Keywords:
- Metastatic Breast Cancer
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Site Reference ID/Investigator# 8352 | San Francisco, California 94115 |
| Site Reference ID/Investigator# 6920 | Harvey, Illinois 60426 |
