CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Indinavir in association with Vinblastina +/- Bleomicinadrug
Likely dose
Indinavir in association with Vinblastina +/- Bleomicina 800 mgfrom 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.

Search/NCT01067690
NCT01067690Phase 2Completed
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Phase II Trial for the Treatment of Advanced Classical Kaposi's Sarcoma With the HIV Protease Inhibitor Indinavir in Combination With Chemotherapy

Barbara Ensoli, MD, PhD·interventional·Posted Feb 11, 2010·Updated Aug 30, 2016

In Brief

A Phase 2 clinical trial evaluating Indinavir in association with Vinblastina +/- Bleomicina for Kaposi's Sarcoma. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the clinical response to daily Indinavir oral administration in association with a conventional chemotherapy based on cycles of systemic Vinblastine +/- Bleomycin in patients affected by advanced classical (non HIV-associated) Kaposi's sarcoma

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKaposi's Sarcoma
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 11, 2010
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2015
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 16.4 years ago

Interventions

Indinavir in association with Vinblastina +/- Bleomicinadrug

Treatment consists in an induction phase where daily Indinavir (800 mg x 2/die, orally) will be combined together with systemic Vinblastine (10 mg intravenously) +/- Bleomycin (15 mg intramuscularly) in cycles administered every 3 weeks. As maximal response will occur, patients will undergo 2 additional Vinblastine +/- Bleomycin (consolidation) cycles upon continuous treatment with Indinavir. This will be followed by a maintenance phase with Indinavir alone (800 mg x 3/die, orally) in responder patients.