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A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies


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

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Trial Information

A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies


Inclusion Criteria:



Inclusion criteria include, but are not limited to, the following:

1. Confirmed diagnosis of solid tumor malignancy

2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

3. Adequate hepatic, renal and bone marrow function

4. Resolution of toxicity from prior therapy (except alopecia) to grade less than or
equal to 1

Exclusion Criteria:

Exclusion criteria include, but are not limited to, the following:

1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or
other evidence of central nervous system involvement

2. Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg

3. Patients with medical history of myocardial infarction, unstable angina pectoris,
coronary/ peripheral artery bypass graft, congestive heart failure or ventricular
arrhythmia

4. Patients with deep vein thrombosis or pulmonary embolism within last 3 months

5. Patients with serious non healing wound or acute ulcer

6. Patients with treatment resistant or bleeding peptic ulcer disease, erosive
esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious
or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic
event within last 3 months

7. Patients with history of abdominal or tracheal-esophageal fistula

8. Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors

9. Prior treatment with bevacizumab within last 6 weeks

10. Pregnant or breast-feeding women

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:

Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)

Outcome Description:

Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) administered in combination with aflibercept (ziv-aflibercept) in patients with advanced solid malignancies

Outcome Time Frame:

Day 1 to Day 28

Safety Issue:

Yes

Principal Investigator

Clinical Trial Management

Investigator Role:

Study Director

Investigator Affiliation:

Regeneron Pharmaceuticals

Authority:

Canada: Health Canada

Study ID:

R910-ST-1114

NCT ID:

NCT01688960

Start Date:

September 2012

Completion Date:

June 2014

Related Keywords:

  • Solid Tumors

Name

Location

Austin, Texas  78705