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

This study is currently recruiting participants.
Verified January 2013 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01773434
First received: January 17, 2013
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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.

2) 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 Intervention Phase
Solid Tumor
 Drug: MORAb-004
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MORAb-004 in Patients With Solid Tumor

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Tolerability and Safety [ Time Frame: Up to 30 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]
    Maximum tolerated dose (MTD) as defined by dose limiting toxicities (DLTs) within the administered range.

  • Optimal Biologic Dose (OBD)- Part II [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: December 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773434

Contacts
Contact: Department of Customer Joy, EJ _MLNCL@hhc.eisai.co.jp

Locations
Japan
Recruiting
Kashiwa, Chiba, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Ryo Nakajima Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01773434     History of Changes
Other Study ID Numbers: MORAb-004-J081-103
Study First Received: January 17, 2013
Last Updated: January 18, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013