Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
Public ClinicalTrials.gov record NCT01335009. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma. Approximately 80 subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression. Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy. Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability).
Study identification
- NCT ID
- NCT01335009
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 16, 2011 (Actual)
- Primary completion
- Dec 2, 2013 (Actual)
- Completion
- Apr 10, 2020 (Actual)
- Last update posted
- Sep 1, 2021
2011 – 2020
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Oncology | Scottsdale | Arizona | 19454 | — |
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| University of Colorado Cancer Center, Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| The University Of Chicago | Chicago | Illinois | 60637 | — |
| Oncology Specialists, SC | Park Ridge | Illinois | 60068 | — |
| University of Iowa Hospital | Iowa City | Iowa | 52242 | — |
| University of Minnesota | Minneapolis | Minnesota | 19454 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Atlantic Health | Morristown | New Jersey | 07962 | — |
| New York University Cancer Institute | New York | New York | 10016 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 19454 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| St. Luke's Hospital & Health Network | Bethlehem | Pennsylvania | 18051 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | — |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01335009, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2021 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01335009 live on ClinicalTrials.gov.