Know Cancer

or
forgot password

A Phase 1 Study of MORAb-004 in Patients With Solid Tumor


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Solid Tumor

Thank you

Trial Information

A Phase 1 Study of MORAb-004 in Patients With Solid Tumor

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability and Safety

Outcome Description:

Tolerability and the safety profile of multiple intravenous (IV) infusions of MORAb-004 in Japanese participants with solid tumors.

Outcome Time Frame:

Up to 30 months

Safety Issue:

Yes

Principal Investigator

Ryo Nakajima

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Co., Ltd.

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

MORAb-004-J081-103

NCT ID:

NCT01773434

Start Date:

December 2012

Completion Date:

June 2015

Related Keywords:

  • Solid Tumor
  • Neoplasms

Name

Location