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

Advanced Solid Malignancies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871559
• Other study ID #: R421-ST-0804
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2009
• Last updated: March 24, 2014
• Start date: June 2009
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Intervention

Drug:
• REGN421(SAR153192)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		18 months	Yes
Secondary	Preliminary evidence of antitumor activity		18 months	No