Trials / Completed
CompletedNCT00483509
Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma
NGR007: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Small Cell Lung Carcinoma (SCLC) Previously Treated With at Least One Therapeutic Regimen
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- AGC Biologics S.p.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic small cell lung carcinoma (SCLC) patients previously treated with at least one therapeutic regimen
Detailed description
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at least one therapeutic regimen, that will be conducted using Simon's two-stage design method.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NGR-hTNF | iv q3W 0.8 mcg/sqm NGR-hTNF |
| DRUG | Doxorubicin | iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion |
Timeline
- Start date
- 2007-02-14
- Primary completion
- 2010-09-22
- Completion
- 2011-05-17
- First posted
- 2007-06-07
- Last updated
- 2019-10-04
- Results posted
- 2019-10-04
Locations
5 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00483509. Inclusion in this directory is not an endorsement.