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A Phase 1, Multiple-Dose Study of the Safety and Tolerability of Single Agent REGN421 Administered Every 2 or 3 Weeks in Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Malignancies

Thank you

Trial Information

A Phase 1, Multiple-Dose Study of the Safety and Tolerability of Single Agent REGN421 Administered Every 2 or 3 Weeks in Patients With Advanced Solid Malignancies


Inclusion Criteria:



1. Male or female 18 years of age or older

2. Histologically diagnosis of advanced solid malignancy, with no standard therapeutic
options of proven benefit.

3. Patients with measurable or non-measurable disease

4. At least 6 weeks must have elapsed since the last dose of bevacizumab (AvastinTM)

5. At least 4 weeks must have elapsed since the last major surgery

6. For women of childbearing potential, a negative urine pregnancy test at the screening
visit

7. Willingness to use adequate contraception during the full course of the study.
Systemic hormonal contraceptive agents are excluded

8. Willing, committed, and able to return for ALL clinic visits and complete all
study-related procedures.

9. Able to read, understand and willing to sign the informed consent form

Exclusion Criteria:

1. Medical history of myocardial infarction or cardiomyopathy

2. Unstable angina

3. NYHA class II - IV congestive heart failure

4. Patients under treatment with more than 2 antihypertensive medications

5. History of bleeding peptic ulcer disease, erosive gastritis, intestinal perforation,
or clinically significant GI hemorrhage within 6 months of study drug administration

6. Diabetic retinopathy

7. Patients requiring anticoagulation

8. Hypersensitivity to doxycycline or related compounds

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

18 months

Safety Issue:

Yes

Principal Investigator

Clinical Trial Management

Investigator Role:

Study Director

Investigator Affiliation:

Regeneron Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

R421-ST-0804

NCT ID:

NCT00871559

Start Date:

June 2009

Completion Date:

April 2014

Related Keywords:

  • Advanced Solid Malignancies
  • Neoplasms

Name

Location

Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Flint, Michigan  48532
Denver, Colorado  
Boston, Massachusetts  
Indianapolis, Indiana  
Tulsa, Oklahoma