Phase I Study, Open, Dose Escalation, in Adult Patients With Advanced Solid Tumours, to Evaluate Tolerability, Pharmacokinetics and Pharmacodynamics of PDM08 Administered Twice a Week Cycles of 4 Weeks.
18 Years
N/A
Both
Malignant Solid Tumours
Trial Information
Phase I Study, Open, Dose Escalation, in Adult Patients With Advanced Solid Tumours, to Evaluate Tolerability, Pharmacokinetics and Pharmacodynamics of PDM08 Administered Twice a Week Cycles of 4 Weeks.
Phase I study, open, dose escalation, in adult patients with advanced solid tumours, to
evaluate tolerability, pharmacokinetics and pharmacodynamics of ascending PDM08 doses
administered twice a week cycles of 4 weeks.
After checking the safety of the first drug doses, a new dose escalation was proposed and
approved by the Ethic Committee and the Medicines Agency.
This clinical trial is carried out in adult patients with advanced solid tumours whose
disease has progressed despite standard therapy, or for which there is no standard
antineoplastic therapy, or are refractory to it.
In pharmacodynamic non clinical studies, PDM08 presented antitumour activity against
different tumour models including, renal, colon, lung, prostate and breast cancer models.
Inclusion Criteria:
- Population: Adult patients with advanced solid tumours whose disease has progressed
despite standard therapy, or for which there is no standard antineoplastic therapy,
or are refractory to it.
- Informed consent must be obtained for each patient, in accordance with the guideline
for Good Clinical Practice (GCP) of the International Conference of Harmonization
(ICH) and with the local requirements.
- Malignant tumour, histologically or cytologically demonstrated.
- Patients age equal or greater than 18 years.
- Patients must not have an ECOG>2 (ECOG 2: Ambulatory and capable of all self-care but
unable to carry out any work activities. Up and about more than 50% of waking hours)
- The life expectancy of the patient should be superior to 3 months.
- Bilirubin<1,5 times the laboratory upper limit.
- AST and ALT less than 2,5 times the laboratory upper limit, In case of liver
metastases to a value less than 5 times the laboratory upper limit.
- Women in fertile age: a pregnant test must be carried out.
- Men and women in fertile age must commit to to practice one method of birth control
during their participation in the trial, and 30 days after the administration of the
last dose of the experimental drug.
- The patient should have renal function parameters (creatinine) not exceeding 1.5
times the normal upper limit.
- The patient must present a hemoglobin > 9 mg/dL.
- The patient must show basal platelet count > 100.000 /mm3.
- Specific criteria:
- Patients included in the expansion cohort must present a measurable disease by RECIST
criteria 1.1, and disease progression in the last 6 months.
- Patients who agree to enter into the pharmacodynamic tumour tissue substudy should
present accessible tissue to carry out the biopsy safely.
Exclusion Criteria:
- Patients who have received chemotherapy, radiotherapy, immunotherapy or
investigational drugs for their disease within 4 weeks prior to PDM08 first dose.
- Patients who have had surgery within 4 weeks before treatment.
- Patients with untreated brain metastases.
- Patients who are pregnant or breast-feeding.
- Those patients who present an intercurrent non-controlled disease including, but not
limited to, active infections, cicatrization problems, congestive heart failure,
unstable angina, cardiac arrhythmia, pulmonary disease with non controlled symptoms,
non controlled psychiatric disorders or social situations that may affect the
compliance with the requirements of the study.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number and grade of adverse events by participant related to PDM08.
Outcome Description:
Drug safety will be measured by the number and grade of adverse events, by participant, related to the drug in study (PDM08) in the cohorts studied: 560 μg, 1.12 mg, 2.24 mg, 3.5 mg and 14 mg, 28 mg and 56 mg administered twice a week for four weeks. The drug will be administered twice a week for four weeks. Safety and tolerability will be measured considering the adverse events occurred, by participant, related with the drug in study, PDM08, at each cohort.
Outcome Time Frame:
6 weeks for each cohort.
Safety Issue:
Yes
Principal Investigator
Jorge Barriuso, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Universitario La Paz - Madrid (Spain)
Authority:
Spain: Spanish Agency of Medicines
Study ID:
2009-017133-21
NCT ID:
NCT01380249
Start Date:
June 2011
Completion Date:
January 2013
Related Keywords:
- Malignant Solid Tumours
- Phase I
- Phase I multiple doses
- PDM08
- Cancer Treatment
- Pharmacokinetics and Pharmacodynamics
- Advanced Solid Tumors
- Prodimed
- Neoplasms
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