Phase I Study of Indibulin in Patients With Solid Tumors

Solid Tumors Clinical Trial

Official title:

Dose-finding and Pharmacokinetic Trial of Orally Administered D-24851 to Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591136
• Other study ID #: IBL1001
• Status: Completed
• Phase: Phase 1
• First received: December 26, 2007
• Last updated: July 18, 2012
• Start date: April 2003
• Est. completion date: September 2008

Study information

• Verified date: July 2012
• Source: Ziopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationNetherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• indibulin
Dose escalation, daily dosing for 14 days every 3 weeks, for up to 4 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziopharm

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicities		4 months	Yes
Secondary	pharmacokinetics		4 months	No