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

Phase 1
18 Years
Not Enrolling
Solid Tumors

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Trial Information

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

Inclusion 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Jonathan Lewis, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

ZIOPHARM Oncology, Inc


United States: Food and Drug Administration

Study ID:




Start Date:

April 2003

Completion Date:

September 2008

Related Keywords:

  • Solid Tumors
  • Neoplasms