A clinical trial studying Paclitaxel with or without MM-121 for patients with advanced ovarian cancer

• Conditions: Patient with Platinum Resistant/Refractory Advanced Ovarian Cancers.; MedDRA version: 15.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003576-36-NO
• Lead Sponsor: MERRIMACK PHARMACEUTICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-24
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 210

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 Recurrence of disease following completion of platinum therapy of < 6 months
o Incomplete response or progression during most recent platinum based therapy
- Clinically eligible for weekly paclitaxel – per the investigator?s judgment
- Willing to submit unstained tumor tissue if available for analysis from primary surgery or before baseline Willing to undergo a pre-treatment biopsy
o Availability of a cancerous lesion for biopsy that is in a location amenable to image guided core biopsy
o Of adequate size (i.e. diameter at least 1 cm) to permit biomarker evaluation in sample -per investigator?s judgment
- = 18 years of age
-Candidates for chemotherapy
-Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- Measurable disease according to RECIST v1.1
- ECOG Performance Score (PS) of = 2
- Recovered from clinically significant effects of any prior surgery, radiotherapy or other antineoplastic therapy; patients with a known peripheral neuropathy must present as Grade 1 or less, according to National Cancer Institute common terminology criteria [NCI CTCAE], version 4.0, to be eligible for inclusion
- Adequate bone marrow reserves as evidenced by:
o ANC > 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified