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ZIO-201-T and doxorubicin

Phase 1

Advanced Cancer | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Last Updated: Sep 17, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

ZIO-201-T and doxorubicin · 1 trial · 1 indication

Phase 1 1
NCT00608803Phase 1 Study of ZIO-201-T in Combination With Doxorubicin in Solid TumorsAdvanced Cancer
COMPLETED30 Analytics
PHASE1COMPLETED
Phase 1 Study of ZIO-201-T in Combination With Doxorubicin in Solid Tumors
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Toxicities
5 months

Secondary Endpoints

Pharmacokinetics
5 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single armEXPERIMENTALOnce the maximum tolerated dose (MTD) is determined, an expanded cohort of 20 subjects with advanced, ifosfamide and doxorubicin naive soft-tissue sarcoma subjects will be dosed at the MTD and evaluated for efficacy.

Interventions

NameTypeDescription
ZIO-201-T and doxorubicinDRUGZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. This is a dose escalation arm.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age ≥18 years * Histological or cytological documentation of cancer * Measurable disease * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Ifosfamide and doxorubicin naïve * Life expectancy of at least 12 weeks * Adequate bone marrow, liver, and re...

Countries:United States
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about ZIO-201-T and doxorubicin

What is ZIO-201-T and doxorubicin used for?

ZIO-201-T and doxorubicin is an investigational combination therapy being studied for the treatment of advanced cancer. It is a small molecule modality in Phase 1 clinical development. The combination is intended for patients with advanced solid tumors, as evaluated in a clinical trial conducted in the United States.

Who makes ZIO-201-T and doxorubicin?

ZIO-201-T and doxorubicin is being developed by Alaunos Therapeutics, Inc., a biopharmaceutical company. Alaunos Therapeutics is publicly traded under the ticker symbol TCRT. The company is conducting clinical research to evaluate this combination therapy for advanced cancer.

What phase is ZIO-201-T and doxorubicin in?

ZIO-201-T and doxorubicin is in Phase 1 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. The Phase 1 study has been completed, and the drug remains under clinical investigation for advanced cancer.

What clinical trials is ZIO-201-T and doxorubicin in?

ZIO-201-T and doxorubicin has one completed clinical trial, identified as NCT00608803. This Phase 1 study evaluated the combination in 30 participants with advanced cancer. The trial was conducted in the United States and enrolled adults aged 18 years and older.

Is ZIO-201-T and doxorubicin the same as doxorubicin alone?

ZIO-201-T and doxorubicin is a combination therapy that includes doxorubicin, but it is not the same as doxorubicin alone. The investigational treatment combines ZIO-201-T with doxorubicin, and the clinical trial was designed to study this specific combination in patients with advanced cancer.