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Also known as ZIO-101 (Darinaparsin), Darinaparson, darinaparsin, Zinapar(TM)
ZIO-101 · 5 trials · 8 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 |
|---|---|---|
| Single Arm | EXPERIMENTAL | - |
| oral darinaparsin | EXPERIMENTAL | open label, single arm, dose escalation |
| Name | Type | Description |
|---|---|---|
| Darinaparson | DRUG | 420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest for up to six months |
| 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 (Darinaparsin) | DRUG | IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months |
Inclusion Criteria 1. Subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. Measurable disease is defined as having at least one of the following criteria within 28 days prior to registration: 1. Serum M-protein level \> 0....
ZIO-101 is an investigational small molecule developed for oncology indications, including acute leukemia, multiple myeloma, and solid tumors. It has been studied in Phase 1 clinical trials in patients with hematologic cancers such as acute leukemia, chronic myeloproliferative disease, chronic lymphoproliferative disease, multiple myeloma, lymphoma, and poor-risk myelodysplasia, as well as in solid tumors.
ZIO-101 targets the hedgehog signaling pathway. The hedgehog pathway is involved in cell growth and differentiation, and its dysregulation is implicated in several cancers. By targeting this pathway, ZIO-101 is designed to interfere with signaling that may promote tumor growth.
ZIO-101 is being developed by Alaunos Therapeutics, Inc., which trades under the ticker symbol TCRT. The company is responsible for the clinical development of the drug.
ZIO-101 is in Phase 1 clinical development. It has completed Phase 1 trials and is not approved by the FDA for any indication. The drug remains investigational.
ZIO-101 has been evaluated in three completed Phase 1 trials: NCT00592046 in hematologic cancers, NCT00591396 in solid tumors, and NCT00303199 in multiple myeloma. All trials are completed, and no active trials are currently listed.
Yes, ZIO-101 is also known as darinaparsin. The two names refer to the same investigational drug.