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Darinaparsin

Phase 2

Hematologic Neoplasms | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Last Updated: Jul 19, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Darinaparsin · 2 trials · 4 indications

Phase 2 1Phase 1 1
NCT00421213Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow CancersHematologic Neoplasms
COMPLETED50 Analytics
PHASE2COMPLETED
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
Hematologic NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Response Rate
6 months
Determine Toxicity Profile
One Year

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

Determine Maximum Tolerated Dose
One Year

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

Determine the preliminary activity/efficacy
One Year

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

Determine Pharmacokinetic profile
One Year

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

Secondary Endpoints

toxicities
6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmEXPERIMENTAL -
oral darinaparsinEXPERIMENTALopen label, single arm, dose escalation

Interventions

NameTypeDescription
DarinaparsinDRUG300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria 1. Hodgkin's or non-Hodgkin's Lymphoma. 2. ≥ 1 prior therapy and currently requiring therapy. 3. Evaluable disease (defined by disease-specific criteria listed in Appendix 1) 4. ≥ 18 years of age. 5. ECOG performance score ≤ 2 (see Appendix 2). 6. Life-expectancy ≥ 2 months. 7. W...

Countries:United States
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Frequently asked questions about Darinaparsin

What is Darinaparsin used for?

Darinaparsin is an investigational small molecule being studied for the treatment of hematologic neoplasms and advanced solid tumors. It is in Phase 2 clinical development for these oncology indications. The drug is not FDA approved and remains under clinical investigation.

Who is developing Darinaparsin?

Darinaparsin is being developed by Alaunos Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TCRT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain blood cancers and advanced solid tumors.

What phase is Darinaparsin in?

Darinaparsin is in Phase 2 clinical development for hematologic neoplasms and advanced solid tumors. It is an investigational drug, meaning it has not been approved by the FDA and is still undergoing clinical trials to assess its safety and effectiveness in treating these conditions.

What clinical trials is Darinaparsin in?

Darinaparsin has been studied in two completed clinical trials. NCT00421213 was a Phase 2 study of ZIO-101 in advanced blood and bone marrow cancers with 50 participants. NCT01139346 was a Phase 1 study of oral Darinaparsin in patients with advanced solid tumors with 12 participants. Both trials were conducted in the United States.

Is Darinaparsin the same as ZIO-101?

Yes, Darinaparsin is also known as ZIO-101. The Phase 2 clinical trial NCT00421213, which studied the drug in advanced blood and bone marrow cancers, refers to it as ZIO-101. This alternative name is used in some clinical research contexts.