Phase IB Study of Indibulin Using Positron-Emission Tomography (PET) Scans

NCT00591890 | Completed Phase 1

• 1 other identifier: IBL1003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• anti-tumor effect on PET Scan

  7 weeks

Secondary Outcomes (1)

• toxicities

  6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: indibulin

Interventions

indibulin DRUG

dose escalation of indibulin given twice daily for 21 days, to be repeated every 28 days.

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:

• Histological or cytological confirmation of advanced cancer, refractory to standard therapies.
• Received at least one prior therapy and requires additional treatment.
• ≥18 years of age.
• ECOG performance score ≤ 2 (see Appendix 3).
• 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.
• 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.
• 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 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

You may not qualify if:

• 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.

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

Interventions

indibulin

Study Officials

• Jonathan Lewis, MD

  Alaunos Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• 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: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: March 1, 2009
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

US (1)