Trials / Completed
CompletedNCT00484432
Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Ovarian Cancer
NGR012: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Ovarian Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- AGC Biologics S.p.A. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the trial is to document the response rate in patients affected by metastatic ovarian cancer, treated with NGR-hTNF plus doxorubicin. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.
Detailed description
This is a phase II, open-label,single arm, non-randomized study that will be conducted in patients affected by metastatic ovarian cancer, that will be conducted using Simon's two-stage design method.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NGR-hTNF | NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs |
| DRUG | doxorubicin | Doxorubicin: 60mg/m² every 3 weeks, until cumulative dose of 550 mg/m² |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2007-06-08
- Last updated
- 2018-09-27
Locations
2 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00484432. Inclusion in this directory is not an endorsement.