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Cisplatin liposomal

Phase 1

Osteosarcoma Metastatic | Small molecule | Oncology |Insmed Incorporated|Last Updated: Aug 1, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

Cisplatin liposomal · 1 trial · 1 indication

Phase 1 1
NCT00102531Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the LungOsteosarcoma Metastatic
COMPLETED19 Analytics
PHASE1COMPLETED
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
Osteosarcoma MetastaticUnlock trial analytics

Study Endpoints

Primary Endpoints

The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.
4 to 48 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cisplatin liposomal 24 mg/m2EXPERIMENTALInhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
Cisplatin liposomal 36 mg/m2EXPERIMENTALThe study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2

Interventions

NameTypeDescription
Cisplatin liposomalDRUG -
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Eligibility Criteria

Age Range13 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung * Patients with histologically proven, fully malignant high-grade osteosarcoma of bone * Measureable pulmonary metastases * Less than grade 3 neuropathies, insignificant decreases in...

Countries:United States
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