AN OPEN LABEL, RANDOMISED, PHASE II STUDY OF AS1404 IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH PLATINUM-SENSITIVE RECURRENT OVARIAN EPITHELIAL CANCER - Not available

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2004-004375-11-ES
• Date of registration: 03/11/2005
• Prospective Registration: No
• Primary sponsor: Antisoma Research Limited
• Public title: AN OPEN LABEL, RANDOMISED, PHASE II STUDY OF AS1404 IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH PLATINUM-SENSITIVE RECURRENT OVARIAN EPITHELIAL CANCER - Not available
• Scientific title: AN OPEN LABEL, RANDOMISED, PHASE II STUDY OF AS1404 IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH PLATINUM-SENSITIVE RECURRENT OVARIAN EPITHELIAL CANCER - Not available
• Date of first enrolment: 03/03/2005
• Target sample size: 70
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004375-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: Double blind: Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Germany, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
i) Age equal to, or greater than 18 years.

ii) ECOG performance status 0-2.

iii) Life expectancy greater than or equal to 3 months.

iv) Have first recurrent ovarian epithelial cancer, confirmed by imaging, with a progression-free interval of greater than 6 months after response to platinum-based chemotherapy.

v) At least six months since prior chemotherapy or radiotherapy (except palliative radiation where the target lesion is not in the field of the radiation) and recovery from any related toxicities.

vi) Have histologically confirmed ovarian epithelial cancer, with at least one unidimensionally measurable lesion according to the RECIST criteria (Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan)).

Haematological and biochemical indices at screening within the following ranges:

vii) An absolute neutrophil count of =2.0 x 10E9/l,

viii) A platelet count of =100 x 10E9/l,

ix) A haemoglobin level of > 10 g/dl,

x) Adequate hepatic and renal function as defined by serum bilirubin < 25 micromol/l; alkaline phosphatase, ALT and AST < 2.5 times the upper limit of normal; serum creatinine < 120 micromol/l or creatinine clearance =60 mL/min.

xi) Be willing and able to provide written informed consent and in the opinion of the Investigator be able to comply with the study assessments and follow-up.


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:
i) Patients who have undergone or those who have had major surgery within the past 4 weeks, chemotherapy or radiation therapy (except palliative).

ii) Who progressed during prior platinum based chemotherapy and or have a known history of hypersensitivity to paclitaxel, carboplatin or any of their excipients.

iii) Previous exposure to AS1404 or other vascular targeting agents.

iv) Received blood transfusions or growth factors to aid haematological recovery within two weeks of scheduled baseline visit.

v) Concurrent severe and/or uncontrolled co-morbid medical condition within 2 weeks of screening.

vi) Clinically significant cardiac arrhythmias and known QTc prolongation.

vii) Evidence of severe or uncontrolled systemic disease that in the opinion of the Investigator might interfere with the patient's participation in the study, including but limited to unstable or uncompensated respiratory disorder, cardiac failure, hepatic, renal or metabolic disorders including uncontrolled diabetes mellitus.

viii) A history of alcoholism, drug addiction; or any psychiatric condition which in the opinion of the Investigator would impair the patient’s ability to comply with study procedures.

ix) Pregnant or lactating women. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception, in the opinion of the Investigator (post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
Treatment with the following medications within two weeks of AS1404 administration or the expected need for such treatments during the study period:

x) Medications known to modulate serotonin including but not limited to:
Antidepressants (including but not limited to monoamine oxidase inhibitors (MAOIs), tetracyclics, tricyclics, SSRIs)

Pethidine
Amphetamines
Tryptophan
Dextromethorphan
Tramadol

xi) Medications known to affect the QT interval including but not limited to:

Antiarrhythmics: Quinidine, Disopyramide, Procainamide (NAPA), Sotalol, Ibutilide, Amiodarone
Calcium-channel blockers: Bepridil, Lidoflazine
CNS-active agents: Thioridazine, Tricyclic antidepressants, Pimozide
Antibiotics: Erythromycin, Pentamidine, cotrimoxazole
Antihistamines: Terfenadine, Astemizole
Miscellaneous: Terodiline, liquid protein diets, ketanserin organophosphorus insecticides, Cisapride, Probucol

xii) Concurrent or previous malignancy of a different tumour type except for adequately treated non-melanoma skin cancer or CIN.

xiii) Clinical or radiological evidence of CNS metastases.

xiv) Symptomatic peripheral neuropathy =NCI-CTC grade II.

xv) Unresolved bowel obstruction.

xvi) Symptomatic brain metastases.

xvii) Evidence of any other significant clinical disorder or laboratory finding that in the opinion of the Investigator compromises the patient safety during study participation.

xviii) Participation in any investigational drug study in which the study drug has not subsequently obtained a product license.



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

Health Condition(s) or Problem(s) studied

Platinum Sensitive Recurrent Ovarian Epithelial Cancer

Intervention(s)

Product Name: AS1404 (DMXAA)
Pharmaceutical Form: Solution for injection
Current Sponsor code: AS1404
Other descriptive name: DMXAA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Product Name: paclitaxel
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: paclitaxel
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 175-

Product Name: carboplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: carboplatin

Primary Outcome(s)

Main Objective: The overall aim of this study is to determine whether AS1404 will increase efficacy of carboplatin and paclitaxel combination in treating patients with platinum-sensitive recurrent ovarian epithelial cancer.

Primary end point(s): The tumour response rate and time to progression.

The duration of response and stable disease·

One year and median survival.

Safety and tolerability of the combination.

Secondary Objective: To determine the safety and tolerability of the combination.

Secondary ID(s)

2004-004375-11-GB

AS1404-202