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

Ovarian Cancer Clinical Trial

Official title:

Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753545
• Other study ID #: D0810C00019
• Secondary ID: 2008-003439-18
• Status: Completed
• Phase: Phase 2
• Start date: August 28, 2008
• Est. completion date: October 12, 2023

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: October 12, 2023
• Est. primary completion date: June 30, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 130 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Hypersensitivity
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• AZD2281
Tablets Oral BID
• matching placebo
matching placebo bid

Locations

Country	Name	City	State
Australia	Research Site	East Bentleigh
Australia	Research Site	Melbourne
Australia	Research Site	Randwick
Australia	Research Site	South Brisbane
Austria	Research Site	Innsbruck
Austria	Research Site	Wein
Austria	Research Site	Wien
Belgium	Research Site	Brussels
Belgium	Research Site	Leuven
Canada	Research Site	Quebec
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Czechia	Research Site	Brno
Czechia	Research Site	Olomouc
Czechia	Research Site	Praha 10
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
France	Research Site	Bordeaux
France	Research Site	Caen Cedex
France	Research Site	Lyon Cedex 08
France	Research Site	Nantes
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Reims Cedex
Germany	Research Site	Essen
Germany	Research Site	Freiburg
Germany	Research Site	Göttingen
Germany	Research Site	Hannover
Germany	Research Site	Kiel
Germany	Research Site	Marburg
Germany	Research Site	München
Germany	Research Site	Ulm
Germany	Research Site	Wiesbaden
Israel	Research Site	Jerusalem
Israel	Research Site	Jerusalem
Israel	Research Site	Ramat Gan
Israel	Research Site	Tel-Aviv
Israel	Research Site	Zerifin
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Amsterdam
Poland	Research Site	Grzepnica
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Iasi
Romania	Research Site	Suceava
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Orenburg
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Pyatigorsk
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Voronezh
Spain	Research Site	Córdoba
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Valencia
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Ternopil
Ukraine	Research Site	Uzhhorod
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Sutton
United Kingdom	Research Site	Wirral
United States	Research Site	Berkeley	California
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boston	Massachusetts
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Estonia,  France,  Germany,  Israel,  Netherlands,  Poland,  Romania,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])	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)]	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.
Secondary	Overall Survival (OS)	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.	Follow up every 12 weeks post progression, assessed maximum up to 90 months.
Secondary	Objective Response Rate (ORR) (According to RECIST)	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	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.
Secondary	Disease Control Rate	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]	Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
Secondary	Duration of Response	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.	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.
Secondary	Percentage Change From Baseline in Tumour Size at Week 24	Percentage change from baseline to Week 24 in target tumour size.	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.
Secondary	Best Percentage Change in Cancer Antigen 125 (CA-125) Levels	Best percentage change from baseline in CA-125 level	CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.
Secondary	Best Objective Response	Best overall response from radiologic assessments. [FAS]	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.
Secondary	RECIST and CA-125 Response Separately and Combined	RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]	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.
Secondary	Time to Earlier of CA-125 or RECIST Progression	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]	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.
Secondary	Improvement Rate for FACT-O Symptom Index (FOSI)	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]	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary	Improvement Rate for Trial Outcome Index (TOI)	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]	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary	Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)	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]	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary	FACT-O Symptom Index (FOSI) Time to Worsening	The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary	Trial Outcome Index(TOI)Time to Worsening	The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Secondary	Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening	The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]	Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

External Links

•   CSR_Synospsis-D0810C00019.pdf