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A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 232 in Adult Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors

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Trial Information

A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 232 in Adult Subjects With Advanced Solid Tumors


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

- Willing to undergo pre-dose core needle tumor biopsies

- 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

- Prior bone marrow transplant

- History or presence of hematological malignancies

- Active infection requiring intravenous (IV) antibiotics

- Anti-tumor therapy

- Therapeutic or palliative radiation therapy

- Currently enrolled in another investigational device or drug study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

Subject incidence of adverse events, dose limiting toxicities, and clinically significant changes in vital signs, weight, ECGs and clinical laboratory tests

Outcome Time Frame:

36 months

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Institutional Review Board

Study ID:

20120106

NCT ID:

NCT01723020

Start Date:

November 2012

Completion Date:

June 2015

Related Keywords:

  • Advanced Malignancy
  • Advanced Solid Tumors
  • Cancer
  • Oncology
  • Oncology Patients
  • Tumors
  • Solid Tumors
  • Neoplasms

Name

Location

Greenville Hospital SystemGreenville, South Carolina  29605
Research SiteDanbury, Connecticut  
Research SiteCharleston, South Carolina