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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02393898
Date of registration:	12/03/2015
Prospective Registration:	Yes
Primary sponsor:	Hoffmann-La Roche
Public title:	BELOVA Data Collection: Safety and Efficacy of Frontline Bevacizumab Treatment in Participants With Ovarian Cancer 70 Years and Older
Scientific title:	BELOVA: A Non-Interventional Study to Collect Data on the Safety and Efficacy of Frontline Bevacizumab Treatment in Ovarian Cancer Patients 70 Years and Older
Date of first enrolment:	April 23, 2015
Target sample size:	76
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02393898
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Belgium

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 70 years and older

- No treatment with any other investigational agent within 28 days or 2 half-lives
(whichever is longer) prior to enrollment

Exclusion Criteria:

- Contraindications, warnings, and precautions for bevacizumab

Age minimum: 70 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Intervention(s)

Drug: Paclitaxel

Drug: Bevacizumab

Drug: Carboplatin

Primary Outcome(s)

Time to First Incidence of Adverse Events of Special Interest [Time Frame: Per routine clinical practice during bevacizumab treatment (up to 15 months)]

Percentage of Participants with Adverse Events [Time Frame: Per routine clinical practice during bevacizumab treatment (up to 15 months)]

Secondary Outcome(s)

Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab [Time Frame: Every 3 weeks per routine clinical practice for up to 18 weeks]

Comprehensive Geriatric Assessment Subscale Scores [Time Frame: Baseline, end of chemotherapy (up to 18 weeks), and after 10 and 15 months of bevacizumab treatment or at disease progression (up to 15 months overall)]

Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) [Time Frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall)]

Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg) [Time Frame: Every 3 weeks according to SmPC for up to 15 months]

Overall Survival [Time Frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall)]

Percentage of Participants with Complete or Partial Response According to RECIST [Time Frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall)]

Total Number of Bevacizumab Doses [Time Frame: Every 3 weeks according to SmPC for up to 15 months]

Secondary ID(s)

ML29515

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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