Pretreated Advanced Ovarian Cancer MedDRA version: 9.1 Level: PT Classification code 10057529 Term: Ovarian cancer metastatic
Conditions
Interventions
Trade Name: Yondelis 0.25 mg and 1.0 mg
Product Name: Yondelis
Product Code: ET-743
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Trabectedin
CAS Number: 1
Sponsors
Pharma Mar S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Eastern Cooperative Oncology group (ECOG) performance status (PS) = 2. 3. Patients with histologically proven relapsed ovarian carcinoma. 4. Prior treatment with at least one line of platinum compounds and taxanes, with no more than two prior lines of platinum-based therapy, and no more than three prior lines of chemotherapy. 5. Recovered from toxicity associated with prior treatments to National Cancer Institute Common Terminology Criteria version 3.0 (NCI-CTCAE) grade 0/1 (except for alopecia). 6. Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (for phase II only). 7. Acceptable hematological and biochemical function, including: absolute neutrophil count (ANC) = 1.5 x 109/l, platelet count > 100 x 109/l, creatinine 2.5 x ULN, evaluate the hepatic AP isoenzyme and/or gamma-glutamyltransferase (GGT) and/or 5’ nucleotidase, whose values must be within the ULN. 8. Women of child-bearing potential must have a negative pregnancy test prior to the treatment initiation and use a medically approved method of contraception during the trial and for four months after the last administration of study drug. 9. Voluntarily signed and dated written informed consent prior to any specific study procedures. 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. Pregnant or lactating women. 2. Prior exposure to trabectedin or oxaliplatin. 3. Known allergy to any component of trabectedin, oxaliplatin or dexamethasone. 4. Contraindications for the use of corticosteroids. 5. Clinical symptoms of brain metastasis. 6. History of another neoplastic disease (except basal cell carcinoma or uterine cervix carcinoma in situ adequately treated), unless in remission for = 5 years (for phase II only). 7. Symptomatic sensitive neuropathy grade > 1 as per NCI-CTCAE, version 3.0. 8. Less than three weeks between treatment with radiotherapy, hormone therapy, biological therapy, investigational product or chemotherapy (six weeks for nitrosoureas or mitomycin-C) and inclusion. 9. Other serious and/or relevant diseases that, in opinion of the Investigator, are incompatible with the protocol (including any of the following): a. History of cardiac disease, such as myocardial infarction, in the year prior to enrollment in the clinical trial, symptomatic/uncontrolled angina pectoris, congestive heart failure or uncontrolled cardiac ischemia, or arrhythmia, abnormal left ventricular ejection fraction, or uncontrolled arterial hypertension. b. Active infection. c. Active or chronic liver or renal disease. d. Major surgery in the two weeks prior to entering the clinical trial. 10. Patients unable to comply with the study protocol owing to psychological, social or geographical reasons. 11. Participation in another clinical trial or concomitant treatment with any investigational product within 21 days prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase Ib Phase Ib stage: To determine the recommended dose (RD) of the combination of trabectedin and oxaliplatin in patients with advanced ovarian cancer. Phase II Phase II stage: To determine the antitumor activity of the combination of trabectedin and oxaliplatin, administered at the RD established in the phase Ib stage, in patients with advanced ovarian cancer.;Secondary Objective: Phase Ib only To determine the efficacy of the combination of trabectedin and oxaliplatin. Phase Ib/II To determine the safety profile of this trabectedin-oxaliplatin regimen in this population. To determine the pharmacokinetic (PK) profile for each drug when administered in combination. To determine the pharmacogenomic (PGx) profile of tumor samples from the patients participating in this trial. Hypothesis-generating exploratory PGx analyses will be conducted to correlate the molecular parameters found in the tumor samples of the patients with the clinical results achieved with the trabectedin-oxaliplatin regimen.;Primary end point(s): Phase Ib stage: The determination of the RD will be evaluated in patients who are treated and followed for at least one cycle of the combination, or who experience a DLT during the first cycle. The MTD will be the level at which = 2/3 or = 2/6 evaluable patients have a DLT in Cycle 1. The RD will be the dose level immediately below the MTD. A minimum of ten evaluable patients will be treated at the RD. Phase II stage: Overall response rate (ORR), defined as the percentage of patients with confirmed objective response (OR), either complete (CR) or partial (PR) response according to the RECIST criteria. | — |
Countries
France
Outcome results
None listed