Phase 2
Completed N=210
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
Source: ClinicalTrials.gov NCT00900627 ↗Enrolled (actual)
210
Serious AEs
23.0%
Results posted
Sep 2014
Primary outcomePrimary: Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel — 2; 1; 2; 0 Number of Dose Limiting Toxicities
Summary
The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel |
2; 1; 2; 0; 1; 0 | — |
| PRIMARY Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone |
8.7; 9.1 | 0.679 |
| SECONDARY Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone |
52; 35; 11; 6; 41; 29 | 0.026 sig |
| SECONDARY Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone |
NA; NA | 0.607 |
Eligibility Criteria
Inclusion Criteria
- Male/ female with solid, malignant tumour which is unresponsive to standard therapies (Phase I). Female patients with advanced breast cancer with low HER2 expression (Phase II)
- Suitable for paclitaxel chemotherapy
- Life expectancy more than 12 weeks
Exclusion Criteria
- Inadequate kidney, liver, heart, gastric, lung or eye function
- Hypersensitive to paclitaxel
- No symptomatic uncontrolled brain metastases
- Previous taxane chemotherapy within 12 months (Phase II)
Data sourced from ClinicalTrials.gov (NCT00900627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.