Phase I Trial of ZIO-101 in Patients With Solid Tumors
Completed · Phase 1
Conditions studied: Solid Tumors
In brief
Primary Objectives: 1. To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors. 2. To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks. Secondary Objective: 1\. To determine the anti-tumor effects of ZIO-101.
Key facts
- Study ID
- NCT00509782
- Run by
- M.D. Anderson Cancer Center
- People needed
- 47
- Starts
- 2005-05-01
- Expected to finish
- 2008-04-01
- Last updated by the study team
- 2012-08-01
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with histological confirmation solid malignancy refractory to conventional standard therapies for their condition.
- Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents.
- Pediatric patients will be eligible at the discretion of the primary investigator.
- ECOG performance status score </= 2.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods.
- Patients must provide written informed consent prior to treatment.
- At least four weeks from completion of prior therapy to day 1 of study drug.
- Baseline toxicity assessment less than or equal to grade 1 except treatment induced alopecia (NCI Common Terminology Criteria for Adverse Events [CTCAE] version 3.0).
- Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values: - Serum creatinine </= 2 times the upper normal limit OR a calculated creatinine clearance </= 50 cc/min. - Total bilirubin </= 2 times the upper normal limit. - Alanine aminotransferase (ALT), OR aspartate aminotransferase (AST) </= 3 times the upper limit of normal.
- Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 cells/microL.
You may not qualify if…
- Uncontrolled systemic infection (documented with microbiological studies).
- Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Patient has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Patient experiences symptoms even while at rest.
- Concomitant therapy for solid cancer.
- Pregnant subjects and those who are breast-feeding.
- History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I Endometrial/Cervical Carcinoma or Prostate Carcinoma treated surgically, and non-melanoma skin cancer.
- Documented personal or family history of prolonged QT syndrome.
- 12 lead electrocardiogram with a corrected QT interval >/= 460 milliseconds.
- History of confusion or dementia.
- History of seizure disorder.
Where it is running
- U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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