Patient with Platinum Resistant/Refractory Advanced Ovarian Cancers. MedDRA version: 14.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
MERRIMACK PHARMACEUTICALS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order for inclusion, patients must have/be: - Cytological or histological confirmation of locally advanced/metastatic or recurrent epithelial ovarian cancer, or fallopian tube cancer, or primary peritoneal cancer. - Evidence of recurrent or persistent disease following primary chemotherapy - Received at least one prior platinum based chemotherapy regimen for management of primary or recurrent disease. The platinum agent could have been carboplatin, cisplatin, or another organoplatinum compound. High dose therapy, consolidation treatment, or extended therapy delivered after surgical or non-surgical assessment is also permitted. - ”Platinum-resistant or refractory?? according to standard GOG criteria defined as the following: o Treatment-free interval following completion of platinum therapy of 1,500/µl without the use of hematopoietic growth factors; and o Platelet count > 100,000/µl; and o Hemoglobin > 9 g/dL o Serum total bilirubin = 1.5 x ULN o Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline Phosphatase = 2.5 x ULN (= 5 x ULN is acceptable if liver metastases are present and = 5 x ULN of Alkaline Phosphatase is acceptable if bone metastases are present) - Adequate renal function as evidenced by a serum creatinine = 1.5 x ULN - Have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception if hysterectomy and/or oophorectomy were not part of the prior treatment. It is expected that the overwhelming majority of ovarian cancer patients would have had hysterectomy and oophorectomy as part of the original surgery 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 125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: Patients must meet all the inclusion criteria listed above and none of the following exclusion criteria: - Prior radiation therapy to >25% of bone marrow-bearing areas - Evidence of any other active malignancy - Active infection or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled), which in the investigator?s opinion might compromise the patient?s participation in the trial or affect the study outcome - Symptomatic CNS disease - Known hypersensitivity to any of the components of MM-121 or who have had hypersensitivity reactions to fully human monoclonal antibodies - Received treatment, within 30 days prior to the first scheduled day of dosing, with any investigational agents that have not received regulatory approval for any indication or disease state - Received other recent antitumor therapy including: o Investigational therapy administered within the 30 days prior to the first scheduled day of dosing in this study o Radiation or other standard systemic therapy within 14 days prior to the first scheduled dose in this study, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation - NYHA Class III or IV congestive heart failure or LVEF less than normal, per institutional guidelines or < 55%, if not otherwise specified by institutional guidelines. Patients with a significant history of cardiac disease (i.e. uncontrolled blood pressure, unstable angina, myocardial infarction within 1 year or ventricular arrhythmias requiring medication) are also excluded - History of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL, unless the patient has been desensitized in accordance with the institutional protocol - Any other medical condition deemed by the Investigator to be likely to interfere with a patient?s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone based on Progression Free Survival (PFS) in advanced ovarian cancers resistant or refractory to platinum agents. - To correlate a pre-specified five biomarker panel reflective of ErbB3 signaling activity with the clinical outcome of patients (correlation between PFS and other clinical efficacy criteria with biomarker signature);Secondary Objective: - To compare the efficacy of the combination of MM-121 plus paclitaxel to paclitaxel alone using: o Overall survival o Objective response rate and duration of response o Clinical benefit rate, defined as complete response (CR), partial response (PR), and disease stabilization (SD) lasting at least 6 months - To further characterize the safety profile of the MM-121 plus paclitaxel combination - To gather exploratory data on additional potentially predictive set of biomarkers to be measured in serum and tumor tissue - To determine the immunogenicity of the MM-121 plus paclitaxel combination;Primary end point(s): PFS;Timepoint(s) of evaluation of this end point: Every 8 weeks from first dose, corresponding with the patients Recist Evaluations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival, ORR, CBR. ;Timepoint(s) of evaluation of this end point: @death, and every 8 weeks from first dose, corresponding with the patients Recist Evaluations. | — |
Countries
Belgium, Czech Republic, France, Germany, Italy, Norway, Spain, United States
Contacts
Public ContactMerrimack MM121 Clinical Trial Mger
MERRIMACK PHARMACEUTICALS, INC
Outcome results
None listed