A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma
Completed · Phase 1
Conditions studied: Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors, Glioblastoma, Multiple Myeloma
In brief
First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma
Key facts
- Study ID
- NCT01723020
- Run by
- Kartos Therapeutics, Inc.
- People needed
- 107
- Starts
- 2012-12-27
- Expected to finish
- 2017-09-25
- Last updated by the study team
- 2021-09-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Santa Monica, California, United States
- Research Site — Norwalk, Connecticut, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Hackensack, New Jersey, United States
- Research Site — New Brunswick, New Jersey, United States
- Research Site — New York, New York, United States
- Greenville Hospital System — Greenville, South Carolina, United States
- Research Site — Greenville, South Carolina, United States
- Research Site — Lyon, France
- Research Site — Villejuif, France
- Research Site — Amsterdam, Netherlands
- Research Site — Rotterdam, Netherlands
- Research Site — Utrecht, Netherlands
Full record on ClinicalTrials.gov
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