Phase I Study of Indibulin in Patients With Solid Tumors

NCT ID: NCT00591136

Last Updated: 2012-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2008-09-30

Brief Summary

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

Conditions

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

indibulin

Intervention Type: DRUG

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

Interventions

indibulin

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

Intervention Type: DRUG

Other Intervention Names

ZIO-301

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Chronic use of H2-antagonists or proton pump inhibitors.
• Any other cancer treatment during the study or administered within the last 4 weeks (6 weeks for nitrosoureas, mitomycin C, high-dose carboplatin or extensive radiotherapy) before start of study treatment, except irradiation of non-target lesions for symptom relief and bi-phosphonate treatment of bone metastases.
• Clinically symptomatic brain metastases or leptomeningeal disease.
• Neurological or psychiatric disease or drug or alcohol abuse which would interfere with the patients proper completion of the protocol assignment.
• Administrative reasons:
• Anticipated non-availability for study visits/procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alaunos Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Lewis, MD, PhD

Role: STUDY_DIRECTOR

ZIOPHARM Oncology, Inc

Locations

Amsterdam, , Netherlands

Utrecht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 30120268 (View on PubMed)

Other Identifiers

IBL1001

Identifier Type: -

Identifier Source: org_study_id