Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
22 participants
INTERVENTIONAL
2007-06-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
indibulin
Dose escalation of indibulin given twice daily for up to 6 months
Interventions
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indibulin
Dose escalation of indibulin given twice daily for up to 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ≥ 18 years of age
3. ECOG performance score ≤ 2 (see Appendix 3)
4. Eligible subjects MUST have at least one measurable lesion as defined by RECIST 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.
5. Life-expectancy ≥ 12 weeks
6. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted \< 2 weeks prior to Baseline:
* Creatinine ≤ 1.5 X upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 cc/min
* Total bilirubin ≤ 1.5 X ULN
* Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 X ULN
* White blood cell count ≥3.0 x 109/L
* Absolute Neutrophil Count (ANC) ≥1.5 x 109/L
* Platelets ≥100 x 109/L
* Hemoglobin ≥ 10 g/dL
7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
Exclusion Criteria
2. Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation
3. Pregnant and/or lactating female (a reliable method of contraception must be used in all men and in women of childbearing potential during the study and for 3 months after last study drug administration).
4. Uncontrolled systemic infection (documented with microbiological studies)
5. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.
6. Radiotherapy during the study or within 3 weeks of study entry
7. Surgery within 4 weeks of start of study drug excluding tumor biopsy for pharmacodynamic parameters
8. Investigational drug therapy outside of this trial during or within 4 weeks of study entry
9. 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
10. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
11. Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance with the study protocol.
18 Years
ALL
No
Sponsors
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Alaunos Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Lewis, MD
Role: STUDY_DIRECTOR
Alaunos Therapeutics
Locations
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Santa Monica, California, United States
Countries
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References
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Kapoor S, Srivastava S, Panda D. Indibulin dampens microtubule dynamics and produces synergistic antiproliferative effect with vinblastine in MCF-7 cells: Implications in cancer chemotherapy. Sci Rep. 2018 Aug 17;8(1):12363. doi: 10.1038/s41598-018-30376-y.
Other Identifiers
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IBL1002
Identifier Type: -
Identifier Source: org_study_id