Phase I Study in Advanced Solid Tumors

NCT00591292 | Unknown Phase 1

• 1 other identifier: IBL1002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Dose escalating study of orally administered indibulin at twice daily schedule in subjects with solid tumors.

Conditions

Solid Tumors

Keywords

cancer; tumor; solid tumor; advanced tumor

Outcome Measures

Primary Outcomes (1)

• toxicities

  6 months

Secondary Outcomes (1)

• pharmacokinetics

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: indibulin

Interventions

indibulin DRUG

Dose escalation of indibulin given twice daily for up to 6 months

Also known as: ZIO-301

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histological or cytological confirmation of advanced cancer, refractory to standard therapies for their condition
• ≥ 18 years of age
• ECOG performance score ≤ 2 (see Appendix 3)
• 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.
• Life-expectancy ≥ 12 weeks
• 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
• Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.

You may not qualify if:

• New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months (see Appendix 5)
• Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation
• 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).
• Uncontrolled systemic infection (documented with microbiological studies)
• 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.
• 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 which could jeopardize the safety of the subject and his/her compliance with the study protocol.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (1)

Unknown Facility

Santa Monica, California, United States

Location

Related Publications (1)

• 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.

  PMID: 30120268 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

indibulin

Study Officials

• Jonathan Lewis, MD

  Alaunos Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: June 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

US (1)