Phase I study using BK-UM against HB-EGF for patients with advanced or recurrent ovarian cancer

UMIN ID: UMIN000001002

Registered date:30/01/2008

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with recurrent ovarian cancer
• Date of first enrollment: 2007/12/01
• Target sample size: 24
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Anticancer agents

Outcome(s)

• Primary Outcome: Determination of the recomemded dose after analizing the dose limiting toxicity
• Secondary Outcome: 1. Evaluation for efficacy of therapy 2. Screening the predictive markers for efficacy of therapy 3. Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1. exclude the patients who have serious illness or suspect to have serious illness menthioned below (1)exclude the patients who have ischemic heart diseases ro arrythmia to give medical treatment (2)exclude the patients who have less than 50% in ejection fraction using echocardiogram (3)exclude the patients who have cardiac dysfunction as grade III or IV of NYHA or have cardiac infarction within 6 months (4)exclude the patients who have liver schirosis beyond medical control (5)exclude the patients who need the oxigen supplement because of pulmonary intestitial pneumonitis or fiibrosis (6) exclude the patients who need or do medical treatment for mental diseases (7) exclude the patients who have serious diabetes beyond medical control (8) exclude the patients who have ileus or subileus (9)exclude the patients who have serious infection beyond medical control 2. exclude the patients who have previously had seriuos allergic sensitivity 3. exclude the patients who have pregnancy or nursing or have possiblity to be pregnant 4. exclude the patients who have previoursly had some anti-serum 5. exclude the patients who have serious other malignancy influenced on their survival 6. exclude the patients who have the agent used in other clinical trial within 4 weeks. 7. exclude the patients who are recognized as inadequate patients by doctors wth resposibility in this clinical trial

Related Information

• Primary Sponsor: Fukuoka University Hospital
• Source(s) of Monetary Support: Japan Science and Technology agency