Dose-Escalation Study of TH-302 in Combination With Doxorubicin to Treat Patients With Advanced Soft Tissue Sarcoma
A Phase 1/2, Multicenter, Dose-Escalation Study to Determine the Safety, Efficacy and Pharmacokinetics of TH-302 in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma
1 other identifier
interventional
107
1 country
9
Brief Summary
The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Advanced Soft Tissue Sarcoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2008
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 26, 2008
CompletedFirst Posted
Study publicly available on registry
August 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
September 25, 2017
CompletedMay 13, 2025
May 1, 2025
4.9 years
August 26, 2008
July 14, 2017
May 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) Measured of TH-302 When Used in Combination With Doxorubicin and Prophylactic Growth Factor Support in Subjects With Advanced Soft Tissue Sarcoma
Two years
Study Arms (1)
1
EXPERIMENTAL75 mg/m2 of Doxorubicin administered by bolus injection starting on Day 1 of a 21-day cycle.
Interventions
TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle. Dose escalation dose levels: Dose level -1 (if needed): 180 mg/m2 Starting dose: 240 mg/m2
Eligibility Criteria
You may qualify if:
- All Subjects:
- At least 18 years of age
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- Pathologically confirmed diagnosis of soft tissue sarcoma of the following subtypes:
- Synovial sarcoma
- High grade fibrosarcoma
- Unclassified, undifferentiated sarcoma
- Liposarcoma
- Leiomyosarcoma (excluding GIST)
- Angiosarcoma (excluding Kaposi's sarcoma)
- Pleomorphic sarcoma/malignant fibrous histiocytoma
- Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate; subjects in the dose escalation cohorts must have progressed since their most recent systemic therapy
- Recovered from reversible toxicities of prior therapy
- Evaluable disease by RECIST criteria (at least one target or non-target lesion for dose escalation cohorts; at least 1 target lesion for dose expansion cohort)
- ECOG performance status of 0 or 1
- +15 more criteria
You may not qualify if:
- Prior therapy:
- Dose escalation cohort: Prior treatment with more than 2 myelosuppressive cytotoxic chemotherapy regimens
- Expanded cohort: Prior systemic therapy for advanced disease (neoadjuvant and adjuvant permitted)
- Low grade tumors according to standard grading systems (eg AJCC Grade 1 and 2)
- Prior therapy with ifosfamide or cyclophosphamide
- Prior therapy with an anthracycline or anthracenedione
- Prior mediastinal/cardiac radiotherapy
- Current use of drugs with known cardiotoxicity or known interactions with doxorubicin (see product label)
- Anticancer treatment with radiation therapy, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), immunotherapy, hormones or other antitumor therapies within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C)
- Significant cardiac dysfunction:
- Any history of congestive heart failure
- Any history of transmural myocardial infarction
- Uncontrolled arrhythmias within the past 6 months
- Angina pectoris requiring antianginal medication within the past 6 months
- Clinically significant valvular heart disease
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ImmunoGenesislead
Study Sites (9)
Arizona Cancer Center
Tucson, Arizona, 85719, United States
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
Stanford University
Stanford, California, 94305, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46204, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washingon University Siteman Cancer Center
St Louis, Missouri, 63110, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, 75201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Wilson
- Organization
- Threshold Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Kristen Ganjoo, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2008
First Posted
August 28, 2008
Study Start
August 1, 2008
Primary Completion
July 1, 2013
Study Completion
October 1, 2013
Last Updated
May 13, 2025
Results First Posted
September 25, 2017
Record last verified: 2025-05