Phase 2
N=211
AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
Ovarian Neoplasms · Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00610714 ↗Enrolled (actual)
211
Serious AEs
34.1%
Results posted
Sep 2011
Primary outcome: Primary: Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) — 47; 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD0530 (Drug); Carboplatin (Drug); Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) |
47; 45 | — |
| SECONDARY Progression-free Survival (PFS) as Evaluated by RECIST |
8.28; 7.79 | — |
| SECONDARY Overall Survival (Number of Deaths) |
12; 14 | — |
Summary
The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of advanced ovarian cancer
- Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy
- Estimated life expectancy of more than 12 weeks
Exclusion Criteria
- Central Nervous System (CNS) metastases
- Received more than 2 prior chemotherapy regimens for ovarian cancer treatment
- Inadequate bone marrow reserve
- Inadequate liver function, renal function or low haemoglobin
- Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable method of contraception
Data sourced from ClinicalTrials.gov (NCT00610714). 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.