recurrent advanced ovarian cancer

Phase 1

• Conditions: recurrent advanced ovarian cancer; MedDRA version: 17.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10016183Term: Fallopian tube cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002755-15-BE
• Lead Sponsor: Ganymed Pharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-27
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

(1)Signed written informed consent
(2)Female patients =18 years of age, no upper age limit.
(3)Histologically or cytologically confirmed CLDN6+ ovarian cancer of any histology type including primary peritoneal or fallopian tube tumors (histological documentation of the original primary tumor is required via a pathology report) that are either:
Patients with symptomatic recurrence
•Primary-refractory to platinum therapy (as evaluated after at least 2 cycles of platinum-containing therapy); OR
•Platinum-resistant population: relapsed <6 months after platinum-therapy; OR
•Patients with recurrence after =2 lines of standard therapy of which at least one is platinum-based OR
Patients with asymptomatic recurrence
•Patients with asymptomatic disease in progression detected by increase of CA125 levels according to GCIG criteria during systematic follow-up (CA125-rise” patients), who had at least one line of standard treatment
(4)Performance status ECOG 0-2
(5)Patients with measurable, non-measurable, or evaluable disease:
•Evaluable disease: defined as a confirmed CA-125 =2 x ULN
•Measurable disease (RECIST 1.1): defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
•Non-measurable disease: includes patients with symptomatic ascites or pleural effusions, lesions that do not meet RECIST 1.1 criteria or biopsy proven recurrence. Patients with clinically evident non-measurable disease must have either an elevated CA125 or histological confirmation of recurrence
(6)Availability of a FFPE tumor tissue sample or tumor cell positive paracentesis fluid samples (abdominal- or pleural cavity) for the assessment of CLDN6 positivity
(7)Life expectancy of >12 weeks
(8)Adequate organ function defined as:
•Adequate hematologic function (ANC =1000/µl, platelets =100.000/µl, hemoglobin =8.5 g/dl [5.6 mmol/l] (can be post transfusion))
•Adequate renal function (serum creatinine =1.5 mg/dl [114.5 µmol/l] or creatinine clearance rate =30 ml/min)
•Adequate liver function (serum total bilirubin =2 x ULN, AST/ALT =3 x ULN)
(9)Patients of child-bearing potential must have a negative ß-HCG urine test within 72 hours before receiving treatment

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 79
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

(1)Patient is pregnant or breast-feeding
(2)Prior allergic reaction or intolerance to a monoclonal antibody (humanized or chimeric)
(3)Any prior anti-tumor therapy within 14 days prior to the start of IMAB027 treatment
(4)Other concurrent anticancer therapies
(5)HIV infection in medical history or active, medicinally not well controlled Hepatitis B or C infection
(6)History of any one or more of the following cardiovascular conditions within the past 6 months:
•Myocardial infarction (T-Wave/Non-T-Wave)
•Unstable angina pectoris
•Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
•History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT). Patients with recent DVT who have been or are treated with therapeutic anti-coagulant agents (excluding warfarin) for at least 6 weeks are eligible
(7)Other investigational agents or devices concurrently or within 14 days before start of IMAB027 treatment. If half-life of prior investigational agent is >7 days, distance to prior investigational agent should be at least two half-lives. Patients with prior radiotherapy are allowed, if discontinued at least 14 days prior to the first dose of study medication. Tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
(8)Any hemoptysis or bleeding event that is clinically relevant within 2 weeks of first dose of study drug
(9)Clinical symptoms of brain metastases or tumor-associated spinal cord compression.
(10)Need for continuous, systemic immunosuppressive therapy. Concurrent systemic immunosuppressive therapy, in particular systemic corticoids must be stopped 2 weeks prior first treatment. Inhaled and topically applied steroids are allowed. Systemic steroids should be avoided as long as patient is under study medication.
(11)Any other medical condition that would, in the opinion of the Investigator, limit the patient’s ability to complete the study.

Study & Design

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