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Also known as ZIO-101-C, S-dimethylarsino-glutathione, Zinapar (TM)
darinaparsin · 3 trials · 3 indications
a primary outcome measure is to determine the toxicity profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
a primary outcome measure is to determine the maximum tolerated dose of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
a primary outcome measure is to determine the preliminary activity/efficacy of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
a primary outcome measure is to determine the pharmacokinetic profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle
| Arm | Type | Description |
|---|---|---|
| oral darinaparsin | EXPERIMENTAL | open label, single arm, dose escalation |
| Single Arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| darinaparsin | DRUG | dose escalating, starting at 200 mg twice per day for 21 days continuous followed by a 7 day rest per cycle. |
| ZIO-101-C (Darinaparsin) | DRUG | Dose Escalation study, 200 mg - 900 mg, cumulative daily dose split to be taken BID 7 times a week (\>8 hours between doses) for 3 weeks followed by 1 week of rest |
Inclusion Criteria: * Subjects with histological or cytological confirmation of advanced cancer (solid tumor) that is refractory to standard therapies for their condition; * Men and women of ≥18 years of age; * ECOG performance score ≤2 * Eligible subjects with solid tumors MUST have at least one m...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Darinaparsin is an investigational small molecule being studied for the treatment of advanced solid tumors. It has been evaluated in a Phase 1 clinical trial in adult patients with advanced solid tumors. It is not approved for commercial use and remains in clinical development.
Darinaparsin is being developed by Alaunos Therapeutics, Inc., which trades under the ticker TCRT. The company sponsored the clinical evaluation of the drug in advanced solid tumors.
Darinaparsin is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.
Darinaparsin has been studied in one completed Phase 1 trial, NCT01139346, titled Study of Oral Darinaparsin in Patients With Advanced Solid Tumors. The trial enrolled 12 adult patients in the United States and evaluated oral darinaparsin in advanced solid tumors.
No, darinaparsin is not FDA approved. It is an investigational small molecule that has completed a Phase 1 trial in advanced solid tumors. It remains in clinical development and is not available for commercial use.