None listed
Conditions
Interventions
Masitinib Type of group
Masitinib should be taken in a sitting position with a large glass of water (250 ml or 8 oz). Patients with a history of drug allergy or anaphylactic shock should be monitored closely during the first week of therapy. Gemcitabine is administered by 30-minute IV infusion. This should be repeated once every 7 days for a maximum of 3 weeks, followed by a week of rest.
Sponsors
None listed
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female Participant, with advanced / metastatic ovarian epithelial cancer confirmed by histology or cytology (including primary peritoneal cancer and primary fallopian tube cancer) either: a.Ovarian cancer refractory to first-line treatment with platinum (progression during first-line platinum-based chemotherapy) b. ovarian cancer resistant to first-line treatment with platinum (recurrence within 6 months after the completion of first-line chemotherapy); c. candidate for third-line treatment (refractory, resistant or sensitive to second-line therapy based on platinum or patients who had a progression after another type of second-line chemotherapy) 2. The patient has recovered from all acute toxic side effects of prior therapy or surgical procedures up to grade ≤ 1 on common toxicity criteria for adverse events (Common Toxicity Criteria for Adverse Event, CTCAE v4.03), except for the laboratory values. 3. The patient has at least one target lesion that can be measured in one dimension, according to the response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors, RECIST) 4. ECOG of functional status ≤ 2 5. Patient with adequate organic function - Absolute neutrophil count (ANC) ≥ 1.5 x 109 / L - Hemoglobin ≥ 10 g / dl - Platelets (PTL) ≥ 75 x 109 / L. - AST / ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastasis) - Gamma GT ≤ 2,5 x ULN (≤ 5 x ULN in case of liver metastasis) - Bilirubin ≤ 1,5x ULN (≤ 3xULN in case of liver metastasis) - Normal creatinine or, in case of abnormal creatinine, creatinine clearance ≥ 50 mL / min (Cockcroft and Gault formula) - Albumin> 1 x LLN - Proteinuria 3 months 7. Patient weight> 40 kg and BMI> 18 kg / m2 8. Woman ≥ 18 years 9. Patient with a nutritional risk index (NRI) ≥ 83.5, that is, without malnutrition or moderate malnutrition; the IRN is calculated as follows: NRI = 1.519 x serum albumin level + 0.417 x (current weight / base weight) x 100 - serum albumin in g / L - calculation of the basis weight with the Lorentz formula for PB ideal in women: (height - 100) - ((height - 150) / 2) 10. Woman of childbearing age (who enters the study after a menstrual period and has tested negative for pregnancy), who agrees to use a highly effective contraceptive method and an acceptable contraceptive method by her male partner during the study and for up to 3 months (6 months for gemcitabine) after the last treatment. Highly effective contraceptive methods include: - Combined hormonal contraceptive (with estrogen and progesterone) associated with inhibition of ovulation: oral, intravaginal or transdermal - Hormonal contraceptive only with progesterone associated with inhibition of ovulation: oral, injectable or implantable - Intrauterine device (IUD) - Hormonal intrauterine device (SIU) - Bilateral tubal occlusion - Vasectomized couple (azoospermia medically evaluated) - Sexual abstinence (Its reliability must be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient) - Acceptable methods of contraception include: - Oral hormonal
Exclusion criteria
Exclusion criteria: 1. Patient intolerant to gemcitabine 2. Patient who has not recovered from any significant treatment toxicity prior to the start of the study (≥ grade 2) 3. Patient who presents cardiac disorders defined by at least one of the following states: - Patient with a recent cardiac history (in the last 6 months) of: - Acute coronary syndrome - Acute heart failure (class III or IV of the NYHA classification) - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, sudden death with resuscitation) - Patient with heart failure class III or IV of the NYHA classification - Patient with serious conduction disorders that are not prevented with permanent electrostimulation (atrioventricular block of grade 2 and 3, sinoatrial block) - Syncope without known etiology in 3 months - Severe hypertension not controlled, according to the investigator´s criteria, or symptomatic hypertension 4. Pregnant or breast-feeding patient 5. Patient with active metastasis of the central nervous system (CNS) or with a history of metastasis in the CNS 6. Patient treated for a cancer different from epithelial ovarian cancer within 5 years prior to enrollment, with the exception of basal cell carcinoma or localized cervical cancer 7. Patient with a history of poor compliance or history of drug / alcohol abuse, or excessive alcohol consumption that would interfere with their ability to comply with the study protocol, or current or past psychiatric illness that may interfere with the ability to comply with the Study protocol or give informed consent WASHING PERIOD 1. Patient who underwent some major surgery in the 4 weeks prior to the baseline visit 2. Patient treated with any agent under investigation in the 4 weeks before the baseline visit 3. Patient who underwent systemic chemotherapy in the 4 weeks prior to the baseline visit 4. Patient who underwent radiotherapy in the 4 weeks prior to the baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Stratified logarithmic rank test Measure:Comparison of global survival. Timepoints:time from baseline to documented death | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Stratified logarithmic rank test Measure:Overall progression-free survival Timepoints:date of documented progression or death from any cause during the study | — |
Countries
Belgium, Brazil, Bulgaria, Chile, Colombia, Egypt, France, Mexico, Netherlands, Peru, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactJannet Legua
GENEXION PERU S.A.C.
Outcome results
None listed