Phase IB Study of Indibulin Using Positron-Emission Tomography (PET) Scans
NCT ID: NCT00591890
Last Updated: 2012-07-19
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2007-10-31
2009-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single Arm
indibulin
dose escalation of indibulin given twice daily for 21 days, to be repeated every 28 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
indibulin
dose escalation of indibulin given twice daily for 21 days, to be repeated every 28 days.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Received at least one prior therapy and requires additional treatment.
3. ≥18 years of age.
4. ECOG performance score ≤ 2 (see Appendix 3).
5. 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.
6. 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.
7. Life expectancy ≥12 weeks.
8. 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
9. Ability to tolerate repeated blood sampling and adequate vascular access.
10. Serum glucose levels ≤200 mg/dL.
11. Provide written informed consent in compliance with ZIOPHARM policies and the Independent Ethics Committee with jurisdiction over the site.
12. Subjects of childbearing potential must agree to use a barrier method of contraception throughout the study and for 3 months after study drug administration.
Exclusion Criteria
2. Uncontrolled diabetes mellitus
3. Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation.
4. Pregnancy and/or lactation.
5. Uncontrolled systemic infection (documented with microbiological studies)
6. 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.
7. Radiotherapy during the study or within 3 weeks of study entry.
8. Surgery within 4 weeks of start of study drug excluding tumor biopsy for pharmacodynamic parameters.
9. Investigational drug therapy outside of this trial during or within 4 weeks of study entry.
10. 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.
11. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
12. Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance with the study protocol.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alaunos Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan Lewis, MD
Role: STUDY_DIRECTOR
Alaunos Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Santa Monica, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
Review additional registry numbers or institutional identifiers associated with this trial.
IBL1003
Identifier Type: -
Identifier Source: org_study_id