An Open-label, Multicenter, Phase 2 Study of Single-agent CNTO 888 (an anti- CCL2 Monoclonal Antibody) for the Treatment of Subjects with Recurrent Ovarian Cancer
- Conditions
- MedDRA version: 12.0 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrentrecurrent Ovarian cancer
- Registration Number
- EUCTR2009-011250-17-GB
- Lead Sponsor
- Centocor B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• Women age = 18 years
• Sign an informed consent document indicating that they understand the purpose of
and procedures required for the study and are willing to participate in the study
• Histological documentation of epithelial ovarian or Fallopian tube cancer, or
primary peritoneal cancer of serous, endometrioid, or clear cell subtypes
• Received at least 1 prior complete 6-cycle platinum-containing chemotherapy
regimen and no more than 3 regimens of chemotherapy in total
• Recurrence or progression after platinum-based treatment for ovarian cancer
defined according to the following subsets:
- Group A: Relapse-free interval after all prior platinum-based treatment of
> 6 months and who are not candidates for further platinum therapy due to a
hypersensitivity to platinum or for other reasons
- Group B: Relapse-free interval after the first or any subsequent platinumbased
treatment of < 6 months
• Measurable disease at baseline according to RECIST guidelines
• Subjects in Group B must be willing and able to have pretreatment and
posttreatment biopsies (see Section 4.4)
• ECOG performance status during screening and immediately prior to the first dose
of study agent: (Attachment 3)
- Status of 0, 1, or 2 for subjects who have had only 1 prior chemotherapy
regimen
- Status of 0 or 1 for subjects who have had more than 1 chemotherapy prior
regimen
• Adequate bone marrow, liver, and renal function within 2 weeks prior to the first
dose of study agent as described below:
- Hemoglobin = 9.0 g/dL (5.6 mmol/L; 90 g/L) without transfusion
dependency or erythropoiesis-stimulating agents
- Absolute neutrophil count (ANC) = 1.0 x 109/L (1000/mm3) without
hematopoietic cytokine support
- Platelets = 100 x 109/L (100,000/mm3) without transfusion dependency or
hematopoietic cytokine support
- Coagulation prothrombin time (PT) or international normalized ratio (INR),
and activated partial thromboplastin time (aPTT) = 1.5 x ULN
- AST and ALT = 3 x ULN if no liver metastasis; = 5 x ULN with liver
metastasis
- Total bilirubin = 1.5 x ULN
- Serum creatinine = 1.5 x ULN
• Female subjects must be postmenopausal (at least 12 months since last menses),
surgically sterile, abstinent, or if sexually active and of child-bearing potential be
practicing an effective method of birth control (e.g., prescription or oral
contraceptives, contraceptive injections, intrauterine device, double-barrier method,
contraceptive patch, male partner sterilization) before study entry and throughout
the study; have a negative urine pregnancy test at screening.
• Willing/able to adhere to the prohibitions and restrictions specified in this protocol
• To participate in
Potential subjects who meet any of the following criteria will be excluded from
participating in the study:
• Tumors of malignant mixed mesodermal types or primary mucinous tumors of the
ovary
• Subjects who have refractory disease (relapsed disease during any prior platinumbased
chemotherapy regimen)
• Subjects with a relapse-free interval of > 12 months after the most recent platinumbased
treatment
• Known or symptomatic CNS metastases
• Requires parenteral hydration or nutrition; has evidence of bowel obstruction; a
history of abdominal fistula, gastrointestinal perforation or bleeding, or intra-abdominal abscess
• Presence of or at high risk for intestinal obstruction by, or transluminal intestinal
growth of, ovarian cancer or any concurrent malignancy
• Residual toxicities resulting from previous therapy that are = Grade 2 (except for
alopecia)
• Known allergies, hypersensitivity, or intolerance to CNTO 888 or its excipients
(refer to Section 14.1, Physical Description of Study Drug) or clinically significant
reactions to chimeric or human proteins
• Bleeding diathesis or requires concurrent therapeutic dose of anticoagulation (lowdose
prophylaxis is permitted to maintain IV line patency)
• Received an investigational drug/agent (including vaccines), intraperitoneal cancer
therapy, local radiotherapy or used an investigational medical device within
4 weeks prior to the first dose of study agent or are currently enrolled in an
investigational study
• Concomitant treatment such as, immunotherapy, biotherapy, radiotherapy,
chemotherapy, investigative therapy, or new steroid therapy (see Section 8 for more
details)
• Requires transfusion of blood products to meet eligibility criteria, or within
4 weeks prior to the collection of screening hematology laboratory sample
• Uncontrolled infection, clinically important active infection within 4 weeks prior to
the first dose of study agent, currently receiving treatment for an infection, known
to be seropositive for HIV, or known active hepatitis A, B, or C infection
• Major surgery, medical or surgical interference with the peritoneum or pleura or
significant traumatic injury within 4 weeks prior to the first dose of study agent, or
planning to have surgery (except for minor surgical procedures) during the study,
or planned major surgery within 8 weeks after the last dose of study agent.
Laparoscopy is allowed.
• Serious concurrent illness (medical or psychiatric), altered mental status (eg,
dementia) or any uncontrolled medical condition (eg, uncontrolled diabetes),
including the presence of laboratory abnormalities, that places the subject at
unacceptable risk by participating in the study, limits full compliance, or confounds
the ability to interpret data from the study or that, in the opinion of the investigator,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method