Ovarian CancerNCT02151370
An Observational Study of Avastin (Bevacizumab) in Patients With Ovarian Cancer
An observational study of Ovarian Cancer, run by Hoffmann-La Roche at 1 site in El Salvador.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 3 participants
- Where
- 1 siteEl Salvador
- Study dates
- Mar 2013to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with Advanced FIGO Stage (IIIb to IV) Ovarian Epithelial Cancer with measurable residual disease after surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ascites Control Treating Ovarian Cancer With Bevacizumab: "ACT-OB"
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.
- Conditions
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who require paracenthesis during treatment with Avastin
Measured: 72 weeks
The amount of ascitic fluid extracted during treatment with Avastin
Measured: 72 weeks
Secondary outcomes (3)
Safety: Incidence of adverse events
Measured: 72 weeks
To evaluate Eastern Cooperative Oncology Group (ECOG) performance status before and after start of therapy
Measured: 72 weeks
To determine regional epidemiologic data for the studied population
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151370
- Sponsor's protocol ID
- ML28428
- Status last verified
- May 2014
- First submitted
- 28 May 2014
- Last updated
- 30 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascites Control Treating Ovarian Cancer With Bevacizumab: "ACT-OB"
- ClinicalTrials.gov ID
- NCT02151370
- Acronym / sponsor ID
- ML28428
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with Advanced FIGO Stage (IIIb to IV) Ovarian Epithelial Cancer with measurable residual disease after surgery
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients who require paracenthesis during treatment with Avastin
Time frame: 72 weeks
The amount of ascitic fluid extracted during treatment with Avastin
Time frame: 72 weeks
3 secondary outcomes
Safety: Incidence of adverse events
Time frame: 72 weeks
To evaluate Eastern Cooperative Oncology Group (ECOG) performance status before and after start of therapy
Time frame: 72 weeks
To determine regional epidemiologic data for the studied population
Time frame: 72 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Hoffmann-La Roche at 1 site in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who require paracenthesis during treatment with Avastin (time frame: 72 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.