At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
NGR-hTNF +1 moredrug
Likely dose
NGR-hTNF 1.6 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IB Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Solid Tumors
In Brief
A Phase 1 clinical trial evaluating NGR-hTNF and Doxorubicin for Cancer. Completed, enrolled 15 participants across 4 sites in 2 countries.
Detailed Summary
The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of doxorubicin, 75 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesItaly, Netherlands
Collaborators--
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedMar 2006
Primary CompletionMay 2007
TodayJul 2026
First PostedMar 21, 2006
Enrollment StartFeb 28, 2006
Primary CompletionMay 8, 2007
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.3 years ago
Interventions
NGR-hTNFdrug
0.2, 0.4, 0.8 and 1.6 μg/m²as 60-minute intravenous infusion every 3 weeks
Doxorubicindrug
75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion)