Phase IB Study of Indibulin Using Positron-Emission Tomography (PET) Scans
- Registration Number
- NCT00591890
- Lead Sponsor
- Alaunos Therapeutics
- Brief Summary
Single arm, open label, Phase IB study of indibulin capsules in subjects with advanced solid tumors; eligible subjects will have a baseline PET scan showing a standardized uptake value (SUV) of ≥5.0 in ≥1 lesion on an 18F-FDG (fluorine-18-labeled deoxyglucose) scale.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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Histological or cytological confirmation of advanced cancer, refractory to standard therapies.
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Received at least one prior therapy and requires additional treatment.
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≥18 years of age.
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ECOG performance score ≤ 2 (see Appendix 3).
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At least one measurable lesion as defined by RECIST (Response evaluation criteria in solid tumors) guidelines (see Appendix 4). 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.
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PET scan showing a standardized uptake value (SUV) of ≥5.0 in at least 1 lesion on an 18F-FDG (fluorine-18-labeled deoxyglucose) scale.
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Life expectancy ≥12 weeks.
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Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted <2 weeks prior to Day 1:
- Creatinine ≤1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥50 cc/minute
- Total bilirubin ≤1.5 × ULN
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 × ULN
- White blood cell count ≥3.0 × 109/L
- Absolute neutrophil count (ANC) ≥1.5 × 109/L
- Platelets ≥100 × 109/L
- Hemoglobin ≥10 g/dL
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Ability to tolerate repeated blood sampling and adequate vascular access.
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Serum glucose levels ≤200 mg/dL.
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Provide written informed consent in compliance with ZIOPHARM policies and the Independent Ethics Committee with jurisdiction over the site.
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Subjects of childbearing potential must agree to use a barrier method of contraception throughout the study and for 3 months after study drug administration.
- New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months (see Appendix 5).
- Uncontrolled diabetes mellitus
- Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation.
- Pregnancy and/or lactation.
- Uncontrolled systemic infection (documented with microbiological studies)
- Any other anti-cancer or immunological therapy during the study or within 4 weeks of study entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.
- Radiotherapy during the study or within 3 weeks of study entry.
- Surgery within 4 weeks of start of study drug excluding tumor biopsy for pharmacodynamic parameters.
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry.
- 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.
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance with the study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm indibulin -
- Primary Outcome Measures
Name Time Method anti-tumor effect on PET Scan 7 weeks
- Secondary Outcome Measures
Name Time Method toxicities 6 months