Clinical trial · Interventional
Phase 2 Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone to Treat Metastatic Breast Cancer
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
NCT00645177CI-TRIAL-00009189completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the effect of ABT-869 plus paclitaxel compared to paclitaxel alone on disease progression in metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-869 | Drug | Linifanib | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo for ABT-869 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- 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
- interventionNames
- Drug: ABT-869
- Drug: paclitaxel
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.