Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00645177 | Phase 2 Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone to Treat Metastatic Breast Cancer | PHASE2 | COMPLETED | 10 | — | — | Jul 1, 2008 | Dec 1, 2009 | Jan 29, 2013 | 3 | United States, Mexico |
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | In study, this arm is a randomized (blinded) to ABT-869 arm plus paclitaxel. Note: Prior to randomization, approximately 6-12 subjects will be enrolled in open-label lead-in to assess the tolerability of the combination. The 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 |
| B | PLACEBO_COMPARATOR | In study, this arm is a randomized (blinded) to placebo for ABT-869 plus paclitaxel arm. Note: Prior to randomization, approximately 6-12 subjects will be enrolled in open-label lead-in to assess the tolerability of the combination. The 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 |
| Name | Type | Description |
|---|---|---|
| ABT-869 | DRUG | 0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle |
| paclitaxel | DRUG | 90 mg/m2 IV infusion over 1 hour, weekly every 3 out of 4 weeks |
| Placebo for ABT-869 | DRUG | 0.20 mg/kg (or dose from Lead-in) QD, tablets taken orally days 1-28 of every 28-day cycle |
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 locall...