A Phase 1 Study of MORAb-004 in Patients With Solid Tumor (Study: MORAb-004-J081-103)

Sponsor

Eisai Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01773434

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

11.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, multiple doses, open-label Phase 1 study of MORAb-004 in subjects with solid tumors. Subjects may have any solid tumor without intracranial involvement or metastases that has failed standard chemotherapy.

This study will be conducted in 2 parts: 1) Part 1 will be the dose escalation portion of this study to assess the tolerability and the safety profile of MORAb-004. Dose will escalate in different cohorts as follows: 2, 4, 8 and 12 mg/kg weekly dosing each as a 4-week cycle with no intra-subject escalation. Individual participants may have additional cycles at the same dose until disease progression unless the participants meet the discontinuation criteria.

Part 2 will comprise cohort expansions to further characterize the safety and tolerability of MORAb-004 and to assess preliminary efficacy and the pharmacokinetic/pharmacodynamic relationship of MORAb-004 in gastric cancer and hepatocellular carcinoma (HCC). Three dose levels will be expanded based on the safety profile that was obtained in the dose escalation portion of this study (Part 1): 4 mg/kg (administered on a weekly basis), 8 mg/kg (administered on a weekly basis) and 12 mg/kg (administered every OTHER week).

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: MORAb-004	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MORAb-004	Drug: MORAb-004 MORAb-004 5 mg/mL is administered as an intravenous infusion (IV) in an escalating dose design and will not be escalated or de-escalated in individual participants. Part 1 (Dose escalation): 4 weekly administrations of 2, 4, 8, and 12 mg/kg in four different cohorts on Days 1, 8, 15, and 22 of a 4-week cycle (28 days). Part 2 (Cohort expansion): 4 and 8 mg/kg on Days 1, 8, 15, and 22 of a 4-week cycle (28 days) and 12 mg/kg biweekly administration on Days 1 and 15 of a 4-week cycle in different cohorts. The dosages in Part 2 can be amended considering the results of Part 1.

Arm

Intervention/Treatment

Experimental: MORAb-004

Drug: MORAb-004

MORAb-004 5 mg/mL is administered as an intravenous infusion (IV) in an escalating dose design and will not be escalated or de-escalated in individual participants. Part 1 (Dose escalation): 4 weekly administrations of 2, 4, 8, and 12 mg/kg in four different cohorts on Days 1, 8, 15, and 22 of a 4-week cycle (28 days). Part 2 (Cohort expansion): 4 and 8 mg/kg on Days 1, 8, 15, and 22 of a 4-week cycle (28 days) and 12 mg/kg biweekly administration on Days 1 and 15 of a 4-week cycle in different cohorts. The dosages in Part 2 can be amended considering the results of Part 1.

Outcome Measures

Primary Outcome Measures

Tolerability and Safety [Up to 30 months]
Tolerability and the safety profile of multiple intravenous (IV) infusions of MORAb-004 in Japanese participants with solid tumors.

Secondary Outcome Measures

Maximum Tolerated Dose (MTD)- Part I [Up to 30 months]
Maximum tolerated dose (MTD) as defined by dose limiting toxicities (DLTs) within the administered range.
Optimal Biologic Dose (OBD)- Part II [Up to 30 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Provide written informed consent,
Japanese male and female subjects aged at 20 or older at informed consent,
Have malignant solid tumor, without intracranial involvement or metastasis, diagnosed by standard pathology criteria that has failed or are resistant to standard chemotherapy,
Performance status (PS) is 0 to 1 by Eastern Cooperative Oncology Group,
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,
Survival expectation is 12 weeks or longer after starting MORAb-004 administration

Exclusion criteria:

Have clinically significant cardiovascular disease,
Scheduled for laparotomic surgery due to trauma or other reasons for during the study,
Have clinically significant hemorrhagic event or history, or event with high risk of hemorrhage,
Receiving chronic systemic anticoagulation,
Have evidence of other active invasive malignancy
Females who are lactating or pregnant at Screening or Baseline

Contacts and Locations

Locations

	City	State	Country
1	Chikusa-ku	Aichi	Japan
2	Kashiwa	Chiba	Japan
3	Nagaizumi-cho	Shizuoka	Japan
4	Chuo-ku	Tokyo	Japan

Sponsors and Collaborators

Eisai Co., Ltd.

Investigators

Study Director: Ryo Nakajima, Eisai Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eisai Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01773434

Other Study ID Numbers:

MORAb-004-J081-103

First Posted:

Jan 23, 2013

Last Update Posted:

Nov 10, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Nov 10, 2016