Phase I Study of Indibulin in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Dose-finding and pharmacokinetic trial of orally administered Indibulin to patients with solid tumors.

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

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: indibulin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: indibulin<br>* Dose escalation, daily dosing for 14 days every 3 weeks, for up to 4 months<br>* Other names: ZIO-301;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicities |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics |  | 4 months |