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Also known as Topotecan Liposomes Injection (TLI)
Topotecan Liposomes · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2) |
| B | EXPERIMENTAL | Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2) |
| Name | Type | Description |
|---|---|---|
| Topotecan Liposomes Injection (TLI) | DRUG | TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2) |
Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically confirmed advanced solid tumor that has relapsed, is refractory to standard treatment, or for whom there is no standard therapy available. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 4. Normal organ ...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Tarlatamab |
Topotecan Liposomes is being studied for the treatment of small cell lung cancer, ovarian cancer, and other advanced solid tumors. It is an investigational therapy and is not approved for commercial use. The clinical program has focused on patients with these advanced malignancies.
Topotecan Liposomes works by inhibiting TOP1, also known as topoisomerase I. This enzyme is required for DNA replication. By blocking TOP1, the drug interferes with cancer cell division and leads to cell death. The liposomal formulation is designed to deliver the active small molecule in a controlled manner.
Topotecan Liposomes is being developed by Assertio Holdings, Inc., which trades on the Nasdaq under the ticker symbol ASRT. The company is responsible for the clinical development of this investigational asset.
Topotecan Liposomes is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program has been completed, and no active trials are currently listed for this asset.
Topotecan Liposomes has been evaluated in one completed Phase 1 clinical trial, NCT00765973. The study enrolled 14 participants with small cell lung cancer, ovarian cancer, and other advanced solid tumors. It was conducted in the United States and included adults 18 years and older.
Yes, Topotecan Liposomes is also known as Topotecan Liposomes Injection, or TLI. These names refer to the same investigational drug product developed by Assertio Holdings, Inc. for advanced solid tumors, including small cell lung cancer.