test

Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma

Conditions

Metastatic Melanoma

Trial Phase

Phase 2

Trial Purpose and Description

Trial Purpose

This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma.

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).


Trial Description

MORAb-004 is a monoclonal antibody directed against endosialin, a cell surface glycoprotein, which is expressed on cells involved in tumor vasculature. Studies have found endosialin to play a key role in tumor growth and neovessel formation in numerous cancer types including melanoma. Preclinical pharmacological studies have shown that MORAb-004 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the efficacy of MORAb-004 at two dose levels in subjects with metastatic melanoma, as well as to establish serum pharmacokinetics and pharmacodynamics of the antibody.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria


Inclusion Criteria:

- Histologically confirmed diagnosis of metastatic melanoma

- At least one prior line of systemic treatment with confirmed progression of disease

- Measurable disease, as defined by RECIST, assessed within 4 wks prior to study entry

- At least 3 week interval between first infusion of test article and most recent prior
systemic anticancer therapy

- ECOG Performance Status of 0 or 1

Exclusion Criteria:

- Evidence of other active malignancy requiring treatment within the last 5 years
(other than basal cell or squamous cell carcinoma of the skin), or active brain
metastasis

- Clinically significant heart disease (Congestive heart failure of NYHA Class 3 or 4,
angina not well controlled by medication, or myocardial infarction within 6 mos.), or
ECGs demonstrating clinically significant arrhythmias

- Brain metastasis

- Known allergic reaction to a prior monoclonal antibody therapy

- Previous treatment with MORAb-004
Sponsor:
Morphotek
Dates:
April 2011
Last Updated:
July 15, 2014
Study HIC#:
1107008735

Clinicaltrials.gov ID: NCT01335009