Phase 2
N=265
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00753545 ↗Enrolled (actual)
265
Serious AEs
15.9%
Results posted
Mar 2013
Primary outcome: Primary: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) — 8.4; 4.8 Months — p=<0.00001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD2281 (Drug); matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AstraZeneca
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) |
8.4; 4.8 | <0.00001 sig |
| SECONDARY Overall Survival (OS) |
29.8; 27.8 | 0.02 sig |
| SECONDARY Objective Response Rate (ORR) (According to RECIST) |
12.3; 4.2 | — |
| SECONDARY Disease Control Rate |
53.7; 25.6 | — |
| SECONDARY Duration of Response |
4.2; 2.3 | — |
| SECONDARY Percentage Change From Baseline in Tumour Size at Week 24 |
-0.8; 26.4 | 0.03185 sig |
| SECONDARY Best Percentage Change in Cancer Antigen 125 (CA-125) Levels |
-16.67; 0.00 | — |
| SECONDARY Best Objective Response |
0; 0; 7; 2; 49; 42 | — |
| SECONDARY RECIST and CA-125 Response Separately and Combined |
16; 2; 7; 2; 9; 0 | — |
| SECONDARY Time to Earlier of CA-125 or RECIST Progression |
8.3; 3.7 | <0.00001 sig |
| SECONDARY Improvement Rate for FACT-O Symptom Index (FOSI) |
17.1; 14.8 | — |
| SECONDARY Improvement Rate for Trial Outcome Index (TOI) |
20.0; 18.0 | — |
| SECONDARY Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) |
21.1; 18.9 | — |
| SECONDARY FACT-O Symptom Index (FOSI) Time to Worsening |
2.8; 3.7 | 0.22 |
| SECONDARY Trial Outcome Index(TOI)Time to Worsening |
3.8; 4.6 | 0.67 |
| SECONDARY Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening |
2.8; 4.6 | 0.38 |
Summary
The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy
Eligibility Criteria
Inclusion Criteria
- Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
- Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
- For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
- Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.
Exclusion Criteria
- Previous treatment with PARP inhibitors including AZD2281
- Patients with low grade ovarian carcinoma.
- Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
- Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).
Data sourced from ClinicalTrials.gov (NCT00753545). 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.