Threshold Pharmaceuticals - Various Cancers



TH-302 (HAP) TH-CR-401 TH-CR-401 is a randomized Phase 1 dose escalation trial that will evaluate efficacy and safety of TH-302 in patients with advanced solid tumors. Approximately 50 patients with advanced solid tumors are planned to enroll in the trial that is being conducted in the United States. Up to six patients per dose level will participate in the dose escalation phase of the trial. Once a maximum tolerated dose (MTD) has been established, six additional patients will be enrolled at the MTD level. TH-302 is administered as a 30-minute intravenous infusion weekly for three weeks followed by one week off therapy. Patients who have received one or more regimens of chemotherapy, or for whom no effective therapy is available, are eligible for the trial. Patients will not receive any additional chemotherapy while receiving TH-302. Patients who successfully complete a four week treatment cycle without evidence of significant treatment-related toxicity or progressive disease will continue to receive treatment for up to six cycles. Tumor response will be measured at the end of cycles 2, 4 and 6. Who Can Participate? Selected Inclusion Criteria: In order to participate in this study, a person must meet the following criteria: Males and females, at least 18 years of age Histologically confirmed, locally advanced or metastatic solid malignancy Previously treated with at least one chemotherapy regimen for advanced or metastatic disease OR no curative standard treatment is available Recovered from reversible toxicities of prior therapy Measureable disease by RECIST (at least one target lesion) Selected Exclusion Criteria: Symptomatic brain metastases (screening CT or MRI is not required in asymptomatic subjects) Active clinically significant infection requiring antibiotics History or symptoms of cardiovascular disease particularly coronary artery disease, unstable arrhythmias, or myocardial infarction within the last 6 months Known HIV infection, hepatitis B or hepatitis C Other primary malignancies (other than treated basal cell carcinoma of the skin or treated in situ cervical cancer) within the past 5 years Major surgery within 4 weeks of the start of study treatment, without complete recovery Antitumor therapy within 4 weeks of the start of study treatment Participation in an investigational drug or device study within 28 days of the first day of dosing on this study Please note there are other additional criteria. The study center will determine if you meet all of the requirements for enrollment. For further information on the TH-CR-401 study or to find a clinical trial site nearest you, please contact the Threshold Pharmaceuticals clinical trials group at 1-650-474-8221 or email us at clinicaltrials@thresholdpharm.com. 2-Deoxyglucose (2DG) TH-CR-101 TH-CR-101 is a randomized Phase 1 dose escalation trial that will evaluate efficacy and safety of 2-Deoxyglucose (2DG) in combination with docetaxel in patients with advanced solid tumors. Patients may participate in the study for up to 53 weeks. The trial is being conducted at the following locations: UM Sylvester Comprehensive Cancer Center, Miami, FL Cancer Therapy and Research Center (CTRC), San Antonio, TX Indiana University Cancer Center, Indianapolis, Indiana Cancer Institute of New Jersey, New Brunswick, NJ This trial is currently enrolling men and women with a variety of advanced cancers. Patients will participate in the study for up to 53 weeks. Who Can Participate? Selected Inclusion Criteria: In order to participate in this study, a person must meet the following criteria: Males and females, at least 18 years of age Histologically confirmed, locally advanced or metastatic solid malignancy Previously treated with at least one chemotherapy regimen for advanced or metastatic disease OR no curative standard treatment is available Recovered from reversible toxicities of prior therapy Selected Exclusion Criteria: Symptomatic brain metastases (screening CT or MRI is not required in asymptomatic subjects) Active clinically significant infection requiring antibiotics History or symptoms of cardiovascular disease particularly coronary artery disease, arrhythmias, or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure History of transient ischemic attack, stroke, or seizure disorder or any other CNS disease considered to be significant by the investigator Evidence of hypoglycemia, clinically significant renal disease, clinically significant liver disease (other than liver metastases), diabetes mellitus, gastrointestinal disorder (that could affect absorption or elimination of orally-administered medications), or obstructive uropathy with significant post-void residual during the past 5 years Known HIV infection Other primary malignancies (other than treated basal cell carcinoma of the skin or treated in situ cervical cancer) within the past 5 years Major surgery within 4 weeks of the start of study treatment, without complete recovery Antitumor therapy within 21 days of the start of study treatment Participation in an investigational drug or device study within 28 days of the first day of dosing on this study Please note there are other additional criteria. The study center will determine if you meet all of the requirements for enrollment. For further information on the TH-CR-101 study or to find a clinical trial site nearest you, please contact the Threshold Pharmaceuticals clinical trials group at 1-650-474-8228 or email us at clinicaltrials@thresholdpharm.com. Disclosure of Risks Please note that the safety and effectiveness of this product have not yet been established. As with other anti-cancer treatments, this investigational product may not benefit you and may cause side effects. These side effects could be severe or even life threatening. There may be side effects that are not known or predictable at this time, but that may occur at the time of treatment or later. You should discuss these risks with your physician or a study doctor.