Study Stopped
Sponsor terminated protocol
A Safety and MORAb-028 Dose Determination Study in Subjects With Metastatic Melanoma
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Radiologic Distribution of Ascending Single-Dose Radiolabeled MORAb-028 in Subjects With Metastatic Melanoma
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to evaluate whether therapy with MORAb-028 is safe, effective, and to determine the appropriate dose of MORAb-028 in the treatment of metastatic melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJuly 16, 2014
July 1, 2014
1.5 years
September 29, 2010
July 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of single dose radio labeled MORAb-028 in subjects with metastatic melanoma
Daily for 7 days followed by weekly for 2 weeks, then biweekly for 4 weeks
Secondary Outcomes (3)
Radiologic distribution of a single i.v. infusion of MORAb-028
Daily for 1 week post study drug administration
Pharmacokinetic parameters of labeled and unlabeled MORAb-028
Daily for 7 days followed by weekly for 2 weeks, then biweekly for 4 weeks
The incidence of human antihuman antibody formation
Week 2 and Week 8
Study Arms (4)
Cohort 1
EXPERIMENTALMORAb-028 0.1 mg/kg intravenous
Cohort 2
EXPERIMENTALMORAb-028 0.2 mg/kg intravenous
Cohort 3
EXPERIMENTALMORAb-028 0.5 mg/kg intravenous
Cohort 4
EXPERIMENTALMORAb-028 1.0 mg/kg intravenous
Interventions
Cohort 1: 0.1 mg/kg IV on study day 1 only Cohort 2: 0.2 mg/kg IV on study day 1 only Cohort 3: 0.5 mg/kg IV on study day 1 only Cohort 4: 1.0 mg/kg IV on study day 1 only
Eligibility Criteria
You may qualify if:
- Measurable metastatic melanoma that has failed standard therapy
- Males and females greater than or equal to 18 years of age
- Life expectancy of greater than or equal to 3 months
You may not qualify if:
- Significant cardiovascular impairment
- Clinically significant illness, medical condition, surgical history, or laboratory abnormality that could affect the safety of the subject or negatively impact the study results
- Chemotherapy, radiotherapy, or immunotherapy within 3 weeks prior to administration to MORAb-028
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morphoteklead
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10022, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christina Coughlin, MD, PhD
Morphotek
- PRINCIPAL INVESTIGATOR
Jorge Carrasquillo, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2010
First Posted
September 30, 2010
Study Start
December 1, 2010
Primary Completion
June 1, 2012
Study Completion
September 1, 2012
Last Updated
July 16, 2014
Record last verified: 2014-07