Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT01773434
Eligibility Criteria:
Inclusion criteria:
1. Provide written informed consent,
2. Japanese male and female subjects aged at 20 or older at informed consent,
3. Have malignant solid tumor, without intracranial involvement or metastasis, diagnosed by standard pathology criteria that has failed or are resistant to standard chemotherapy,
4. Performance status (PS) is 0 to 1 by Eastern Cooperative Oncology Group,
5. With no carry-over effect and no adverse drug reaction of prior treatment which may affect the safety evaluation of MORAb-004, except for Grade 1 or 2 neuropathy and alopecia,
6. Survival expectation is 12 weeks or longer after starting MORAb-004 administration
Exclusion criteria:
1. Have clinically significant cardiovascular disease,
2. Scheduled for laparotomic surgery due to trauma or other reasons for during the study,
3. Have clinically significant hemorrhagic event or history, or event with high risk of hemorrhage,
4. Receiving chronic systemic anticoagulation,
5. Have evidence of other active invasive malignancy
6. Females who are lactating or pregnant at Screening or Baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01773434
Study Brief:
Protocol Section:
NCT01773434