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Cisplatin liposomal

Phase 1

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

Cisplatin liposomal development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2005

Cisplatin liposomal target and mechanism

ModalitySmall molecule

Also known as SLIT Cisplatin

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Cisplatin liposomal clinical trials

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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Frequently asked questions about Cisplatin liposomal

What is cisplatin liposomal?

Cisplatin liposomal is an investigational formulation of the chemotherapy agent cisplatin that is delivered by inhalation. It is being developed by Insmed Incorporated (ticker INSM) for the treatment of osteosarcoma metastatic to the lung. The liposomal form is designed to deliver the drug directly to the lungs.

What is cisplatin liposomal used for?

Cisplatin liposomal is being studied for the treatment of osteosarcoma metastatic to the lung. This is a cancer that has spread from the bone to the lungs. The drug is given by inhalation, targeting the metastatic tumors in the lungs. It is not approved for any use and remains investigational.

Who is developing cisplatin liposomal?

Cisplatin liposomal is being developed by Insmed Incorporated, which trades under the ticker symbol INSM. Insmed is a biopharmaceutical company focused on serious and rare diseases. The company has conducted a Phase 1 trial of the inhaled formulation in patients with osteosarcoma metastatic to the lung.

What phase is cisplatin liposomal in?

Cisplatin liposomal is in Phase 1 clinical development. One Phase 1 trial has been completed. The drug is investigational and has not been approved by the FDA for any indication. Further clinical testing would be required before any potential regulatory review.

What clinical trials is cisplatin liposomal in?

Cisplatin liposomal has been studied in one completed Phase 1 trial, NCT00102531, titled "Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung." The trial enrolled 19 participants in the United States and included patients aged 13 years and older. No active trials are ongoing.