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A Phase?Study of Depoxythilone (UTD1) in Patients with Advanced Cancer

A Phase?Study to Assess the Safety, Tolerability, and Pharmacokinetics of Depoxythilone (UTD1) in Patients with Advanced Solid Tumors

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TNC-09000493
Enrollment
Unknown
Registered
2009-08-06
Start date
2007-10-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced malignant tumors including, but not limited to, breast cancer, colorectal cancer, liver cancer, gastric cancer, non-small cell lung cancer, etc.

Interventions

Group A:25 mg/m2 of Depoxythilone
Group B:50 mg/m2 of Depoxythilone
Group C:85 mg/m2 of Depoxythilone
Group D:125 mg/m2 of Depoxythilone
Group E:170 mg/m2 of Depoxythilone
Group F:225 mg/m2 of Depoxythilone

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Histological or cytological confirmed diagnosis of advanced, recurrent or metastatic malignant tumors; 2. Patient with solid tumors that lack standard therapy or have progressed after standard therapy including patients who have previously treated with Taxol; 3. Age limits: min 18 years old, max: 65 years old, both male and female; 4. ECOG performance status of 0-1; Life expectancy of 3 months or more; 5. Adequate organ function for heart, liver, kidney and bone narrow; 6. At least 30 days since prior chemotherapy; 7. Fertile patients must use effective contraception; 8. Patients with measurable or evaluable target lesions; 9. Patient with good compliance, able to understand and willing to sign the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe and /or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, active infection, liver and kidney disorders; 2. Patients in pregnant or nursing; 3. Received any other investigational agents or non-approved drugs within 4 weeks preceding the first dose of UTD1; 4. Patient with uncontrollable mental disease and active infection; 5. Documented hypersensitivity reaction to Cremophor EL; 6. Patient unable to receive hormonotherapy, such as diabetes; 7. Patient with history of uncontrolled mental disease; 8. Patient with lower compliance; 9. Patient not fitted for this study determined by the principal investigator (PI).

Design outcomes

Primary

MeasureTime frame
Clinical effect index;Safety;Clinical effect index;

Countries

China

Contacts

Public ContactBinghe Xu
xubinghe@medmail.com.cn+86 010 87788826

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026