Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trabectedin · 1 trial · 2 indications
In each arms among non progressive patients after the 6 first cycles of Trabectedin : occurrence of progression or death 24 weeks after the date of randomization. Intention to treat analysis. Centralised radiological review.
| Arm | Type | Description |
|---|---|---|
| Continuation of Trabectedin | OTHER | patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle, every 3 weeks until progression/ toxicity |
| "Drug holiday" therapy | OTHER | patient receives 6 cycles of trabectedin, then one dose 15 days after the 6th cycle and he stops the drug until progression and re-challenge |
| Name | Type | Description |
|---|---|---|
| Trabectedin | DRUG | Trabectedin will be administered without drug holiday in Arm A until unacceptable toxicity, progressive disease or patient decision. The treatment beyond disease progression and in case of intolerance will be decided according to investigator discretion. In case of progression after drug discontinuation by patient decision, a re-challenge of Trabectedin is possible. |
| Drug: holiday | OTHER | A drug-holiday will start after the 6th cycle until disease progression, and then Trabectedin will be re-challenged. Trabectedin will be administered until unacceptable toxicity, second evidence of progressive disease or patient decision. |
Inclusion Criteria (for the selection part): * Inoperable or metastatic soft tissue sarcoma and/or uterine sarcoma * Measurable lesions (RECIST 1.1) * Performance status ≤ 2 * Age ≥ 18 * Normal hematological parameters (polynuclear neutrophils ≥ 1500, hemoglobin level ≥ 9 g/dl, platelets counts ≥ 1...
Trabectedin is an investigational small molecule being studied for the treatment of Soft Tissue Sarcoma, including Uterine Sarcoma. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated for its potential role in managing advanced cases of this cancer.
Trabectedin is being developed by Bone Biologics Corp, a company traded on the stock exchange under the ticker symbol BBLG. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Soft Tissue Sarcoma.
Trabectedin is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The ongoing research is focused on assessing its effectiveness in treating Soft Tissue Sarcoma, and it remains in active clinical testing.
Trabectedin has been studied in a completed Phase 2 clinical trial with the identifier NCT01303094. This trial, titled "Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma," enrolled 53 participants in France and included patients with Soft Tissue Sarcoma and Uterine Sarcoma.
Trabectedin is a distinct small molecule drug candidate. It is not known to be the same as any other marketed or investigational drug. Its unique chemical structure and mechanism of action differentiate it from other oncology treatments currently in development.