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NCT01551745 · ClinicalTrials.gov registry record · Phase 2

Salvage Ovarian FANG™ Vaccine + Bevacizumab

A Phase 2 study of Stage IV Ovarian Cancer and Stage III Ovarian Cancer, sponsored by Gradalis.

Completed
Registry status
Phase 2
Development phase
5
Enrollment target
1
Study location

NCT01551745: Completed Phase 2 study of Stage IV Ovarian Cancer and Stage III Ovarian Cancer, sponsored by Gradalis.

NCT01551745 is a Phase 2 study of Stage IV Ovarian Cancer and Stage III Ovarian Cancer that has completed, run by Gradalis. The registered enrollment target is 5 participants, below the 97-participant average among 5 other Stage IV Ovarian Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01551745, a Phase 2 study of Stage IV Ovarian Cancer and Stage III Ovarian Cancer, has completed, sponsored by Gradalis.

COMPLETED
Registry status
Phase 2
Development phase
5 participants
Enrollment target
1
Study location

Study Summary

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.

Primary Outcome

Time to progression (TTP) following bevacizumab integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.

Interventions

  • DRUG Bevacizumab
  • BIOLOGICAL Vigil™ Vaccine

Study Locations (1)

Texas

  • Mary Crowley Cancer Research Centers - Dallas

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2012-03
Est. Completion 2016-04
Phase Phase 2
Gradalis

13 total trials

What the finished NCT01551745 record still lists

NCT01551745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 97-participant average among 5 other Stage IV Ovarian Cancer trials with a reported enrollment target (95% lower).

The record links to 2 conditions, with Stage IV Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Bevacizumab is the first listed.

NCT01551745 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01551745 about?

NCT01551745 is a clinical study titled "Salvage Ovarian FANG™ Vaccine + Bevacizumab". This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 w...

What is the current status of trial NCT01551745?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2012-03. Estimated completion is 2016-04.

What conditions does trial NCT01551745 study?

This clinical trial studies the following conditions: Stage IV Ovarian Cancer, Stage III Ovarian Cancer.

What interventions are being tested in trial NCT01551745?

The interventions under investigation include: Bevacizumab (DRUG), Vigil™ Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01551745?

This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01551745 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT01551745, the US trial registry maintained by the National Library of Medicine. NCT01551745 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.