Advanced Ovarian Cancer MedDRA version: 12.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent
Conditions
Interventions
Product Name: ProLindac
Product Code: AP5346
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: ProLindac
Other descript
Sponsors
ACCESS Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment; 2. Histologically and/or cytologically proven epithelial ovarian cancer; 3. With one and no more than one previous chemotherapy regimen with a minimum 12-month progression free period since the last platinum administration; 4. At least one measurable unidimensional lesion (RECIST version 1.1) with a longest diameter > 10 mm, outside an irradiated field OR Non-measurable disease (non-target lesion) and increasing serum CA-125 levels of at least 2 x upper limit of normal (ULN), reflecting disease progression; increasing CA-125 levels are shown by a >25% increase after 2 successive measurements made in the same laboratory = 4 weeks apart; 5. Age = 18 years; 6. Life expectancy > 3 months; 7. ECOG Performance Status (PS) 0-1; 8. Adequate bone marrow reserve, normal renal and liver function: • Absolute neutrophil count = 2x10E9/L • Platelet count = 100x10E9/L • Hemoglobin = 10 g/dL • Creatinine level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than one prior chemotherapy regimen; 2. Prior treatment with oxaliplatin; 3. Prior high dose carboplatin-based chemotherapy intensification 4. History of prior or concomitant malignancies (other than excised non-melanoma skin cancer or cured in situ cervical carcinoma) within 5 years of study entry; 5. Known brain or leptomeningeal involvement; 6. Other serious illness or medical conditions, such as • history of significant neurological or psychiatric disorders • pre-existing neuropathy NCI-CTCAE grade = 2 • active infection • unresolved bowel obstruction 7. Prior allergic reactions to drugs containing Cremophor®, such as vitamin K or cyclosporine; 8. Prior severe hypersensitivity reaction to organoplatins or taxanes (symptomatic bronchospasm, allergy-related edema/angioedema, hypotension or anaphylaxis); 9. Concurrent treatment with any other experimental drug; 10. Participation in another clinical trial or treatment with any investigational drug within 30 days prior to study entry; 11. Other concomitant anticancer treatment; 12. Pregnant or breast-feeding patients, or with childbearing potential and not using adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ProLindac combined with paclitaxel in patients with advanced epithelial ovarian cancer, previously treated with cisplatin or carboplatin, who are potentially platinum-sensitive (platinum-free, progression-free interval ?12 months);Secondary Objective: To evaluate: The safety of the ProLindac™/paclitaxel combination The pharmacokinetics of the ProLindac/paclitaxel combination Response duration, progression-free survival and overall survival;Primary end point(s): Response rate in all evaluable patients, according to RECIST version 1.1 in patients with measurable disease or according to GCIG-Rustin modified criteria for response based on CA-125 and evaluable lesions in patients without measurable disease | — |
Countries
France
Outcome results
None listed