- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00495144
A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors
July 25, 2012 updated by: Threshold Pharmaceuticals
A Phase I, Multi-Center, Open-Label, Dose-Escalation Study of the Safety, Pharmacokinetics and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors
This is a phase I, multi-center, open-label, dose-escalation study of TH-302 in patients with advanced solid tumors.
TH-302 is a hypoxia activated product designed to exploit the hypoxic nature of tumors.
The study is designed to establish the safety including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of TH-302.
Study Overview
Study Type
Interventional
Enrollment (Actual)
129
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic Arizona
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Scottsdale, Arizona, United States, 85258
- TGen Drug Development Services
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California
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San Francisco, California, United States, 94117
- St. Mary's Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Simon Cancer Center
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Texas
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Dallas, Texas, United States, 75201
- Mary Crowley Cancer Research Centers
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Histologically or cytologically confirmed advanced or metastatic solid malignancy
- Advanced or metastatic solid malignancy previously treated with one or more regimens of chemotherapy or for which no effective therapy is available
- Recovered from toxicities of prior therapy
- Measurable disease by RECIST criteria (at least one target lesion)
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- AST (SGOT) and ALT (SGPT) ≤ 2.5 times upper limit of normal (ULN); if liver metastases are present, then ≤ 5 x ULN is allowed
Acceptable renal function:
- Serum creatinine ≤ ULN
Acceptable hematologic status (without hematologic support):
- ANC ≥ 1500 cells/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9.0 g/dL
- Urinalysis: No clinically significant abnormalities
Acceptable coagulation status:
- PT ≤ 1.3 x ULN
- PTT ≤ 1.3 x ULN
- All women of childbearing potential must have a negative serum pregnancy test and women and men subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose
Exclusion Criteria:
- Prior treatment with high dose chemotherapy
- Prior radiotherapy to more than 25% of the bone marrow
- New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 6 months prior to Day 1, or unstable arrhythmia
- Seizure disorders requiring anticonvulsant therapy
- Symptomatic brain metastases (unless previously treated and well controlled for a period of ≥ 3 months)
- Severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.) or hormones within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C)
- Patients who participated in an investigational drug or device study within 28 days prior to study entry
- Known infection with HIV, hepatitis B, or hepatitis C
- Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation (containing solutol and/or propylene glycol)
- Females who are pregnant or breast-feeding
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Unwillingness or inability to comply with the study protocol for any reason
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of TH-302 administered weekly x 3, repeated every 4 weeks in patients with advanced solid tumors
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Secondary Outcome Measures
Outcome Measure |
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To establish the pharmacokinetics of intravenously administered TH-302
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To assess the anti-tumor activity of TH-302 as measured by objective response and duration of response
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Glen Weiss, MD, Translational Drug Development
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
June 28, 2007
First Submitted That Met QC Criteria
June 29, 2007
First Posted (Estimate)
July 2, 2007
Study Record Updates
Last Update Posted (Estimate)
July 27, 2012
Last Update Submitted That Met QC Criteria
July 25, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TH-CR-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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