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A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Status
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Age
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Sponsor
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Protocol IDs
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Phase I
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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TH-CR-401 NCT00495144
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Trial Description
Summary 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. Eligibility Criteria 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 within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Acceptable hematologic status (without hematologic support):
- Platelet count ≥ 100,000/μL
- Urinalysis: No clinically significant abnormalities
- Acceptable coagulation status:
- 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: - • 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
Trial Contact Information
Trial Lead Organizations/Sponsors Threshold Pharmaceuticals David S. Mendelson | | Principal Investigator |
Glen Weiss, MD | | Principal Investigator |
Trial Sites
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U.S.A. |
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Arizona |
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Scottsdale |
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| | | | | | | | TGen Drug Development Services |
| | Solitaire Lindsay |
Ph: 480-323-1536 |
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Email:
slindsay@shc.org |
| | Glen Weiss, MD | Principal Investigator |
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Tennessee |
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Nashville |
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| | | Sarah Cannon Research Institute |
| | Sheri Mersch |
Ph: 615-329-7249 |
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Email:
Sheri.Mersch@scresearch.net |
| | Howard A. Burris | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00495144 Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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