epithelial ovarian, fallopian or peritoneal cancer MedDRA Classification Code: 10033283 and 10061269 version 7.0 level HLT
Conditions
Interventions
Product Name: Gimatecan
Product Code: ST 1481
Pharmaceutical Form: Capsule*
INN or Proposed INN: Gimatecan
Current Sponsor code: ST1481
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Sigma Tau Industrie Farmaceutiche Riunite S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Advanced epithelial ovarian, fallopian or peritoneal cancer. The histologic diagnosis used for admission into the trial will be the one done at first diagnosis. 2.Patients presenting progressing or recurring disease and evaluable for response according to RECIST criteria or CA125 criteria*. Patients presenting the following features may be enrolled:· - Measurable disease according to RECIST criteria. Patients may or not present non-measurable disease and may or not present an increase in CA 125. - An increase* in CA125. Patients may or not present also non-measurable disease according to RECIST criteria. * When evaluated using CA125 levels, patients to be eligible for the study must be progressing for CA-125, that is presenting levels = 2 UNL on one baseline determination with samples taken within 2 weeks before starting treatment, as per the Gynecologic Cancer Intergroup - GCIG - criteria. 3. Prior chemotherapies – Patients must have been pretreated with platinum and taxanes. One or more prior chemotherapy lines are permitted, up to a maximum of three. Patients presenting the following features may be enrolled: - No more than two prior platinum containing regimens. - At least one platinum regimen containing taxanes (may also be in sequence). - In case the last treatment contained platinum, the progression free interval after the last dose of platinum* must be 18 years. 5. ECOG performance status 9 g/dl; neutrophils > 1.5 x 109/L; platelets > 150 x 109/L. 7. Adequate liver and renal function · alkaline phosphatase £ 1.5 x UNL, if bone metastases present, hepatic isoenzyme should be 2.5 g/dl · creatinine £ 1.5mg/dL or 133 mmol/dL 8. All previous therapies for ovarian cancer must have been discontinued > 4 weeks before study entry and all acute toxicities (excluding alopecia or peripheral neuropathy) of any prior therapy must have resolved to NCI-CTC (Version 2.0) Grade = 1. 9. Life expectancy of at least 3 months. 10. Evidence of a signed and dated informed consent document indicating the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study. 11. Willingness and ability to comply with the study protocol for the duration of the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior radiation therapy to > 30% red bone marrow. 2. Active infection. 3. Any investigational agent received = 4 weeks prior to study entry and/or concurrent enrolment in another clinical trial. 4. Any prior topotecan- or irinotecan - containing regimen or any regimen containing an investigational inhibitor of topoisomerase I. 5. Prior high dose chemotherapy treatment requiring hematopoietic stem cell rescue. 6. Previous major gastrointestinal surgery or diseases that could alter absorption or motility (i.e. active peptic ulcer, inflammatory bowel disease, known intolerance to lactose, malabsorption syndromes). 7. Inability to swallow. 8. Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder. 9. Presence of uncontrolled intercurrent illness or any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study. 10. Previous concomitant malignancy at other site, other than basal or squamous cell carcinoma of the skin or in situ cervical carcinoma within 5 years. 11. Symptomatic brain metastases or leptomeningeal disease requiring therapy. 12. Pregnancy or lactation or unwillingness to use adequate method of birth control. 13. For patients evaluable by CA 125 only: previous treatment with mouse antibodies or previous medication and/or surgery interfering with their peritoneum or pleura during the previous 28 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of single agent gimatecan given orally on a 5 consecutive days schedule every 28 days in patients with advanced epithelial ovarian, fallopian or peritoneal cancer previously treated with platinum and taxanes.;Secondary Objective: - To define the safety profile of gimatecan therapy given orally for 5 consecutive days every 28 days. - To evaluate the activity based on time to event / time related parameters. - To define patients adherence to gimatecan therapy given orally for 5 consecutive days every 28 days. - To perform optional Translational Medicine evaluations, described in an ancillary protocol. These evaluations will be done only in consenting patients, signing a separate informed consent form.;Primary end point(s): response rate, measured according to RECIST criteria or a decline in CA 125 antigen levels, induced by gimatecan administered orally for 5 consecutive days every 28 days. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed