Mullerian Mixed Tumor of OvaryNCT02090127
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient
A study testing ficlatuzumab in people with Mullerian Mixed Tumor of Ovary, run by AVEO Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mullerian Mixed Tumor of Ovary
- What is being tested?
- ficlatuzumab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Per original P05538 protocol
Who cannot join
- Per original P05538 protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanded Access Protocol to Provide Ficlatuzumab to P05538 Patient 0001-000412
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient
Read the detailed description
This treatment protocol will serve as a mechanism to continue to provide ficlatuzumab to patient 0001-000412, who was previously enrolled under protocol P05538 and whom the investigator believes is deriving clinical benefit from ficlatuzumab treatment.
- Conditions
- Mullerian Mixed Tumor of Ovary
- Being tested
- ficlatuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ficlatuzumabDrug
Also called AV-299, SCH 900105
humanized anti-hepatocyte growth factor (HGF) monoclonal antibody IV administration at 16.5mg/kg every 2 weeks with a ±2 day window around dosing dates, as long as subject is deriving clinical benefit as determined by the Investigator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mullerian Mixed Tumor of OvaryStudies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090127
- Sponsor's protocol ID
- AV-299-13-103S
- Status last verified
- Jul 2015
- First submitted
- 14 Mar 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol to Provide Ficlatuzumab to P05538 Patient 0001-000412
- ClinicalTrials.gov ID
- NCT02090127
- Acronym / sponsor ID
- AV-299-13-103S
- Conditions
- Mullerian Mixed Tumor of Ovary
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 18 Mar 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.
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient
Detailed description
This treatment protocol will serve as a mechanism to continue to provide ficlatuzumab to patient 0001-000412, who was previously enrolled under protocol P05538 and whom the investigator believes is deriving clinical benefit from ficlatuzumab treatment.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Per original P05538 protocol
Key exclusion criteria (1 listed)
- Per original P05538 protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ficlatuzumabAlso: AV-299, SCH 900105humanized anti-hepatocyte growth factor (HGF) monoclonal antibody IV administration at 16.5mg/kg every 2 weeks with a ±2 day window around dosing dates, as long as subject is deriving clinical benefit as determined by the Investigator | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Continued Access of Ficlatuzumab to P05538 PatientLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ficlatuzumab in people with Mullerian Mixed Tumor of Ovary, run by AVEO Pharmaceuticals, Inc. at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2015. 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 United States. 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?
Results are not available in the source record.
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.
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 29 Jul 2015.