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Phase I Study of Indibulin in Patients With Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsored by: ZIOPHARM
Information provided by: ZIOPHARM
ClinicalTrials.gov Identifier: NCT00591136
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: indibulin
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Indibulin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Dose-Finding and Pharmacokinetic Trial of Orally Administered D-24851 to Patients With Solid Tumors

Further study details as provided by ZIOPHARM:

Primary Outcome Measures:
  • toxicities [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2003
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm: Experimental Drug: indibulin
Dose escalation, daily dosing for 14 days every 3 weeks, for up to 4 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591136

Locations
Netherlands
Amsterdam, Netherlands
Utrecht, Netherlands
Sponsors and Collaborators
ZIOPHARM
  More Information

Responsible Party: ZIOPHARM Oncology, Inc ( Brian Schwartz, Chief Medical Officer )
Study ID Numbers: IBL1001
Study First Received: December 26, 2007
Last Updated: December 26, 2007
ClinicalTrials.gov Identifier: NCT00591136  
Health Authority: United States: Food and Drug Administration;   Netherlands: Dutch Health Care Inspectorate

Study placed in the following topic categories:
Signs and Symptoms

ClinicalTrials.gov processed this record on January 16, 2009