A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors
NCT ID: NCT00495144
Last Updated: 2012-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
129 participants
INTERVENTIONAL
2007-06-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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TH-302
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Threshold Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Howard Burris, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Glen Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Translational Drug Development
Locations
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TGen Drug Development Services
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
St. Mary's Medical Center
San Francisco, California, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
Countries
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Related Links
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Threshold Pharmaceuticals Company Website
Other Identifiers
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TH-CR-401
Identifier Type: -
Identifier Source: org_study_id