Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer MedDRA version: 9.1 Level: LLT Classification code 10052171 Term: Peritoneal carcinoma MedDRA version: 9.1 Level: LLT Classification code 10061328 Term: Ovarian epithelial cancer
Conditions
Interventions
Product Name: Volociximab
Product Code: M200
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Volociximab
CAS Number: 558480-40-3
Current Sponsor code: M200
Concentratio
Sponsors
Biogen Idec Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must give written informed consent and any authorizations required by local law. 2. Females aged at least 18 years old at the time of informed consent. 3. Advanced (Stage III or IV), histologically-documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies). 4. Radiologically-documented evidence of progressive disease. 5. Platinum-resistant disease defined as having a best response of SD or disease progression during or within 6 months of discontinuing a platinum-based chemotherapy (carboplatinum, cisplatinum, or another organoplatinum compound). 6. Progression during or following treatment with topotecan or liposomal doxorubicin. 7. 3 or fewer prior chemotherapy regimens (including a platinum-based therapy). 8. At least 1 measurable target lesion in accordance with RECIST criteria to assess clinical response (tumors within a previously irradiated field are designated as non-target). 9. ECOG Performance Status 12 weeks. 11. Available paraffin block or unstained paraffin sections on glass slides containing representative tumor tissue from the most recent tumor biopsy/resection. 12. Subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment (about 5 half lives). Acceptable methods of contraception include any of the following: oral, depot, or injectable contraceptives; intrauterine devices (IUDs); NuvaRing®; birth control patch, or double-barrier contraception. Double-barrier contraception must consist of 2 of the following: condom, female condom, diaphragm, cap, shield, sponge, spermicide. The only exceptions to contraception are: subject is postmenopausal for at least 1 year before Study Day 1, subject abstains from sexual intercourse, subject or partner is surgically sterile (i.e., no uterus or no ovaries. Note: subjects who have their fallopian tubes ligated are not considered surgically sterile.) 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. Screening clinical laboratory values: a) Absolute neutrophil count 2.0 x upper limit of normal (ULN) e) AST and ALT >2.5 x ULN (AST and ALT >5 x ULN for subjects with liver metastasis) f) Serum creatinine >2.0 mg/dL g) International normalized ratio (INR) >1.5 h) Activated partial thromboplastin time (aPTT) >1.5 x ULN 2. Clinically significant peripheral vascular disease. 3. Non-epithelial ovarian tumors. 4. Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection. 5. History of abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to Day 1. 6. Serious, non-healing wound, or bone fracture. 7. Known central nervous system or brain metastases. 8. History of uncontrolled psychiatric condition within 6 months prior to Day 1. 9. History of other malignancies within 3 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer. 10. Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohn’s disease, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) sceloderma, or another diseases in which immune function or immune competence is known to be impaired. 11. Any history of lymphoproliferative disorder. 12. Known human anti-murine antibody (HAMA) and/or human anti-chimeric antibody (HACA). 13. Any medical condition that may be exacerbated by bleeding, including a known bleeding disorder such as a coagulation defect, thrombocytopenia, active gastric or duodenal ulcer, or history of GI bleeding. 14. Significant hemoptysis within one year prior to Study Day 1. 15. Any investigational, anti-cancer therapy within 6 weeks prior to Day 1. 16. Any non-investigational, anti-cancer therapy within 4 weeks prior to Day 1. 17. Prior treatment with anti-angiogenic agents. 18. Subjects who require treatment with an anti-coagulant with the exception of low-dose warfarin (< or = 1 mg/day) or heparin for IV catheter patency. (Note: Acetylsalicylic acid and non-steroidal anti-inflammatory drugs are permitted). 19. Subjects who are taking concomitant immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low-dose methotrexate, or azathioprine. (The use of inhaled or intranasal steroids or oral steroids at a dose of < or = 10 mg/day prednisone or its equivalent are permitted.) 20. Active, unstable severe cardiovascular disease, including poorly controlled angina, congestive heart failure (CHF), arrhythmias, myocardial infarction (MI), cardiomyopathy, atrioventricular (AV) block, electrocardiogram (ECG) evidence of acute ischemia, or significant conduction abnormality. 21. History of thromboembolic or cerebrovascular events, such as stroke, or transient ischemic attack (TIA). (Note: Prior history of deep vein thrombosis will not exclude subjects from participating in this study.) 22. Pregnant (positive pregnancy test) or lactating. 23. Inability to comply with study and follow-up procedures. 24. Any condition that, in the opinion of the Investigator, make
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of volociximab when administered at 15 mg/kg per week in subjects with platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.;Secondary Objective: -To evaluate the safety and tolerability of volociximab when administered at 15mg/kg per week. -To evaluate the pharmacokinetics (PK) of volociximab when administered at 15mg/kg per week -To evaluate the pharmacodynamic activity and mechanism of action of volociximab using multiple biologic assessments including studies of serum and whole blood proteins and cellular biomarkers -To investigate the potential relationship between tumour expressions of alpha5beta1 or other relevant markers and clinical response to volociximab. -To measure the concentration of volociximab and protein markers in ascitic fluid obtained from subjects in whom paracentesis can be safely performed and to evaluate potential correlations with clinical outcomes.;Primary end point(s): The primary efficacy endpoint is ORR, defined as the proportion of subjects who have achieved a CR or PR. | — |
Countries
United Kingdom
Outcome results
None listed