An Observational Study of Avastin (Bevacizumab) in Patien... | NCT02151370

Studies
An Observational Study of Avastin (Bevacizumab) in Patients With Ovarian Cancer

NCT02151370

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

May 30, 2014Estimated

Enrollment

3Actual

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Not provided

Countries

El Salvador

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

May 28, 2014

First Submission Date that Met QC Criteria

May 28, 2014

First Posted Date

May 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2014

Last Update Posted Date

May 30, 2014Estimated

Description Module

Brief Summary

This observational study will collect data about safety in female patients with advanced ovarian epithelial cancer with measurable residual disease after surger y. The treating physician has decided to treat the patients with Avastin (bevaci zumab) in combination with chemotherapy followed by Avastin monotherapy accordin g to the local label. Data will be collected for 72 weeks.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of patients who require paracenthesis during treatment with Avastin		72 weeks
The amount of ascitic fluid extracted during treatment with Avastin		72 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety: Incidence of adverse events		72 weeks
To evaluate Eastern Cooperative Oncology Group (ECOG) performance status before and after start of therapy		72 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patients over 18 years of age
Histologically confirmed Advanced Epithelial Ovarian Cancer
Confirmed ascites prior to surgery
Residual disease after surgery
Patients are chemotherapy naïve or have received only one prior line of treatment for their disease
International Federation of Gynecology and Obstetrics (FIGO) stage IIIb or IV disease
Eastern Cooperative Oncology Group (ECOG) performance status <=2
Patients must meet treatment eligibility requirements according to treating physician and Summary of Product Characteristics (SmPC) criteria for Avastin plus chemotherapy.

Exclusion Criteria:

Pregnancy or lactation
Low grade tumors, since this does not necessarily requires systemic treatment. Complete surgical resection
Uncontrollable hypertension
Unexplained bleeding
Known hypersensitivity to any components of bevacizumab
All contraindications specified in the respective Summary of Product Characteristics (SmPC) and/or local labelling of Avastin and the corresponding chemotherapy must be adhered to by the physician.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Female patients with Advanced FIGO Stage (IIIb to IV) Ovarian Epithelial Cancer with measurable residual disease after surgery

Sampling Method

Probability Sample

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases