Clinical trial NCT00591136: Phase I Study of Indibulin in Patients With Solid Tumors
Official title: Dose-finding and Pharmacokinetic Trial of Orally Administered D-24851 to Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Alaunos Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-01-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: toxicities
timeFrame: 4 months
Secondary outcomes:
measure: pharmacokinetics
timeFrame: 4 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
city: Utrecht
country: Netherlands
Study officials:
affiliation: ZIOPHARM Oncology, Inc
name: Jonathan Lewis, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.