CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Cisplatin liposomaldrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Histologically confirmed progressive or recurrent high-grade osteosarcoma metastatic to the lung
  • ✓Measurable pulmonary metastases
  • ✓ECOG performance status 0, 1, or 2
  • ✓Adequate pulmonary function: FEV1 ≥50% predicted and FEV1/FVC ratio ≥65%
Key exclusion· 8
  • ✕Grade 3 or higher painful neuropathy persisting after prior platinum-containing regimen
  • ✕Osteosarcoma secondary to radiation or premalignant conditions
  • ✕Low-grade osteosarcoma, parosteal or periosteal sarcoma
  • ✕Greater than Grade 2 pulmonary toxicity

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00102531
NCT00102531Phase 2Completed
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Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung

Insmed Incorporated·interventional·Posted Jan 31, 2005·Updated Aug 1, 2017

In Brief

A Phase 2 clinical trial evaluating Cisplatin liposomal for Osteosarcoma Metastatic. Completed, enrolled 19 participants across 2 sites.

Detailed Summary

Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteosarcoma Metastatic
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2005
Enrollment StartJan 12, 2005
Primary CompletionMar 1, 2008
Study CompletionMar 17, 2008
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 21.4 years ago

Interventions

Cisplatin liposomaldrug