Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: AZD2281; Drug: matching placebo

• Registration Number: NCT00753545
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-28
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Primary Completion: 2010-06-30
• Results First Submitted: 2012-12-07
• Results First Submitted QC: 2013-02-06
• Results First Posted: 2013-03-11
• Study Completion: 2023-10-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 265

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD2281	AZD2281
2	matching placebo	matching placebo

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])	Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.	PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. \[Full analysis set (FAS)\]

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) (According to RECIST)	Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.	For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set
Disease Control Rate	Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).	Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. \[FAS\]
Duration of Response	Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.	Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. \[Responding patients only\]. There were insufficient responses to enable conclusions to be drawn.
FACT-O Symptom Index (FOSI) Time to Worsening	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.	The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for FOSI set\]
Trial Outcome Index(TOI)Time to Worsening	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.	The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for TOI set\]
Percentage Change From Baseline in Tumour Size at Week 24	Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.	Percentage change from baseline to Week 24 in target tumour size.
Best Percentage Change in Cancer Antigen 125 (CA-125) Levels	CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.	Best percentage change from baseline in CA-125 level
Overall Survival (OS)	Follow up every 12 weeks post progression, assessed maximum up to 90 months.	OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.
Best Objective Response	Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.	Best overall response from radiologic assessments. \[FAS\]
Improvement Rate for Trial Outcome Index (TOI)	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.	The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. \[Evaluable for TOI set\]
RECIST and CA-125 Response Separately and Combined	Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.	RECIST and CA-125 response separately and combined \[Patients evaluable for either CA-125 response or RECIST response\]
Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.	The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. \[Evaluable for FACT-O set\]
Time to Earlier of CA-125 or RECIST Progression	Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.	Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. \[FAS\]
Improvement Rate for FACT-O Symptom Index (FOSI)	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.	The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. \[Evaluable for FOSI set\]
Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.	The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. \[Evaluable for FACT-O set\]

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wirral, United Kingdom