A Multiple-Ascending-Dose Study of the Safety and Tolerability of REGN421(SAR153192) in Patients With Advanced Solid Malignancies

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00871559
• Collaborator: Sanofi (Industry)
• Enrollment: 83
• Locations: 8
• Arm: 1
• Duration (Months): 56
• Patients Per Site: 10.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in patients with advanced solid malignancies.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Malignancies	Drug: REGN421(SAR153192)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Q2W REGN421 (SAR153192) taken once every two weeks (Q2W)	Drug: REGN421(SAR153192)

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability [18 months]

Secondary Outcome Measures

1. Preliminary evidence of antitumor activity [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Aurora	Colorado	United States
2		Indianapolis	Indiana	United States
3		Boston	Massachusetts	United States
4		Detroit	Michigan	United States
5		St. Louis	Missouri	United States
6		New York	New York	United States
7		Columbus	Ohio	United States
8		Oklahoma City	Oklahoma	United States

Sponsors and Collaborators

• Regeneron Pharmaceuticals
• Sanofi

Investigators

• Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00871559
• Other Study ID Numbers: R421-ST-0804
• First Posted: Mar 30, 2009
• Last Update Posted: Mar 26, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Mar 26, 2014