Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over Pharmaceutical / Industry TH-CR-401 NCT00495144

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:

• 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 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):

• 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 UNL

• PTT ≤ 1.3 x UNL

• 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

Hank Lee		Ph: 650-474-8221
		Email: hlee@thresholdpharm.com

U.S.A.
Arizona
	Scottsdale
	TGen Drug Development Services
		Solitaire Lindsay	Ph: 480-323-1536
			Email: slindsay@shc.org
		Glen Weiss, MD	Principal Investigator
Tennessee
	Nashville
	Sarah Cannon Research Institute
		Sheri Mersch	Ph: 615-329-7249
			Email: Sheri.Mersch@scresearch.net
		Howard A. Burris	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00495144
Information obtained from ClinicalTrials.gov on May 27, 2008