Phase I Study of Indibulin in Patients With Solid Tumors

NCT00591136 | Completed Phase 1

• 1 other identifier: IBL1001
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

Dose-finding and pharmacokinetic trial of orally administered Indibulin to patients with solid tumors.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• toxicities

  4 months

Secondary Outcomes (1)

• pharmacokinetics

  4 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: indibulin

Interventions

indibulin DRUG

Dose escalation, daily dosing for 14 days every 3 weeks, for up to 4 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:

• Male or female patient, \>= 18 years of age.
• Histologically/cytologically proven solid malignant tumor, for which standard treatment of proven efficacy are not or no longer available.
• Performance status 0-2 ECOG/WHO.
• Life expectancy \> 3 months.
• Able and willing to undergo blood sampling for pharmacokinetics.
• Written informed consent.

You may not qualify if:

• Safety concerns:
• Any non-compensated or uncontrolled non-malignant condition, such as, symptomatic heart failure, active tuberculosis or any other chronic or active infection.
• History of allergic reaction to one of the ingredients of the trial medication.
• Clinically relevant abnormality in organ function as evidenced by any of the following pa¬ra¬meters:
• White blood cell count: \< 3.0 x 109/l ANC: \< 1.5 x 109/l
• Thrombocytes: \< 100 x 109/l
• Hemoglobin \< 6.0 mM
• Bilirubin (total): \> 1.5 times upper limit of normal range
• ASAT, ALAT: \> 2.5 times upper limit of normal range unless related to metastases in which case \> 5 times upper normal limit is allowed
• Creatinine (serum) \> 135 µmol/l (\> 1.5 mg/100ml) OR
• Creatinine clearance: \< 50 ml/min (calculated according to modified Cockcroft and Gault)
• Breast feeding, pregnancy or planned pregnancy. A reliable method of contraception must be used in men and in women of childbearing potential during the study and for 3 months after last study drug administration.
• Lack of suitability for the trial:
• Concomitant treatment with any other investigational drugs or exposure to another investigational agent within the last 4 weeks prior to study specific screening procedures (period should be extended if the patient has received any drug which is known to have de¬layed toxicity or prolonged half-life).
• Active peptic ulcer or any GI condition that could alter absorption or motility.

Sponsors & Collaborators

• Alaunos Therapeutics: lead

Study Sites (2)

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Utrecht, Netherlands

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, PhD

  ZIOPHARM Oncology, Inc

  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: April 1, 2003
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

NL (2)