Study Complete
Sponsor ID
20101132

A Study of AMG 337 in Subjects with Advanced Solid Tumors

Sponsor ID
20101132
Clinicaltrials.gov ID
NCT01253707
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

First in human, open-label, sequential dose escalation and expansion study of AMG 337 in subjects with advanced solid tumors.

Additional Study Details

Phase
Phase 1
Product
AMG 337
Type
Interventional
Masking
None (Open Label)
Enrollment
111
Additional Study Details

Protocol Summary

Primary Outcome Measures

To evaluate the safety and tolerability of AMG 337 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled.

Timeframe: 4 years

Characterize the pharmacokinetics of AMG 337 when administered orally. PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).

Timeframe: 4 years

Determine the maximum tolerated dose of AMG 337, if possible. The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in < 33% of subjects enrolled in a cohort.

Timeframe: 4 years

Secondary Outcome Measures

Evaluate for clinical responses associated with AMG 337 treatment according to Response Evaluation Criteria In Solid Tumors 1.1 criteria

Timeframe: 4 years

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Houston, TX, United States, 77030
Status
Recruiting
Location
Research Site
Los Angeles, CA, United States, 90025
Status
Recruiting
Location
Research Site
Detroit, MI, United States, 48201
Status
Recruiting
Location
Research Site
Boston, MA, United States, 02114
Status
Recruiting
Location
Research Site
Chicago, IL, United States, 60637
Status
Recruiting
Location
Research Site
Columbus, OH, United States, 43210
Status
Recruiting
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