A Phase II, Single-arm, Japanese Multicenter Trial of TH-302 in Combination with Doxorubicin in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma(EMR 200592-008)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222619

Enrollment

Registered

2014-10-02

Start date

2014-12-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Locally advanced unresectable or metastatic STS

Interventions

investigational material(s) Generic name etc : TH-302 INN of investigational material : Evofosfamide Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigationa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female Japanese subjects greater than or equal to (>=) 15 years of age 2. Able to understand the purposes and risks of the trial and has signed or, if appropriate, the subject's parent or legal guardian has signed a written informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) 3. Pathologically confirmed diagnosis of STS of the histopathologic types as specified in the protocol 4.Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate 5.Recovered from reversible toxicities of prior therapy 6.Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (at least one target lesion outside of previous radiation fields or progressed within a previous radiation field) 7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8.Life expectancy of at least 3 months 9. Acceptable liver function, renal function, hematologic status (without growth factor support for neutropenia or transfusion dependency), and cardiac function as specified in the protocol 10. All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an intrauterine device, intrauterine device [IUD]) with their partner from entry into the trial through 6 months after the last dose. Post-menopausal women must meet the criteria of 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels greater than (>)35 international units per liter (IU/L)

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
efficacy -	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics -	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026