A Phase II Trial of ProLindac™ and Paclitaxel Combination as Second Line-Treatment in Platinum Pretreated Patients with Advanced Ovarian Cancer

• Register: EUCTR
• Last refreshed on: 19 January 2015
• Main ID: EUCTR2010-020030-25-FR
• Date of registration: 09/07/2010
• Prospective Registration: Yes
• Primary sponsor: ACCESS Pharmaceuticals, Inc
• Public title: A Phase II Trial of ProLindac™ and Paclitaxel Combination as Second Line-Treatment in Platinum Pretreated Patients with Advanced Ovarian Cancer
• Scientific title: A Phase II Trial of ProLindac™ and Paclitaxel Combination as Second Line-Treatment in Platinum Pretreated Patients with Advanced Ovarian Cancer
• Date of first enrolment: 24/08/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020030-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

France

Key inclusion & exclusion 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 <1.5 x ULN and creatinine clearance < 60 mL/min calculated according to the Cockroft and Gault formula
• Alkaline phosphatase < 2.5 x ULN and total bilirubin < 1.25 x ULN (in case of liver metastasis, patients with total bilirubin < 1.5 x ULN and alkaline phosphatase < 5 x ULN will be accepted)

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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Advanced Ovarian Cancer
MedDRA version: 12.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent

Intervention(s)

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 descriptive name: AP5346
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-

Trade Name: Paclitaxel
Product Name: Paclitaxel
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Current Sponsor code: paclitaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Trade Name: Paclitaxel
Product Name: Paclitaxel
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Current Sponsor code: paclitaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

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

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

Secondary ID(s)

APC-10E604