A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma
Conditions
Advanced Malignancy - Advanced Solid Tumors - Cancer - Oncology - Oncology Patients - Tumors - Glioblastoma - Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms - Neoplasms, Plasma Cell
Conditions: Keywords
Solid Tumors, Multiple Myeloma
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: AMG 232
Type: Drug
Overall Status
Recruiting
Summary
First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Men or women > 18 years old

- Pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma

- Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.

- Ability to take oral medications and willing to record daily adherance to investigational product

- Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

- Active brain metastases

- For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years

- Active infection requiring intravenous (IV) antibiotics

- Anti-tumor therapy

- Therapeutic or palliative radiation therapy within 30 days of starting treatment

- Currently enrolled in another investigational device or drug study
Locations
Research Site
Santa Monica, California, United States
Status: Recruiting
Research Site
Norwalk, Connecticut, United States
Status: Recruiting
Research Site
Boston, Massachusetts, United States
Status: Recruiting
Research Site
Boston, Massachusetts, United States
Status: Recruiting
Research Site
New Brunswick, New Jersey, United States
Status: Recruiting
Greenville Hospital System
Greenville, South Carolina, United States
Status: Not yet recruiting
Research Site
Greenville, South Carolina, United States
Status: Recruiting
Research Site
Lyon CEDEX 08, France
Status: Recruiting
Research Site
Villejuif, France
Status: Recruiting
Research Site
Amsterdam, Netherlands
Status: Recruiting
Research Site
Rotterdam, Netherlands
Status: Recruiting
Research Site
Utrecht, Netherlands
Status: Recruiting
Start Date
December 2012
Completion Date
October 2016
Sponsors
Amgen
Source
Amgen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page