Clinical trial NCT01688960: Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies
Official title: A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2012-09-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)
timeFrame: Day 1 to Day 28
Secondary outcomes:
measure: Pharmacokinetics (PK)
timeFrame: Day 1 to Day 170
measure: Immunogenicity
timeFrame: Day 1 to Day 170
measure: Antitumor activity
timeFrame: Day 1 to Day 170
measure: Pharmacodynamics (PD)
timeFrame: Day 1 to Day 170
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
city: New York
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: San Antonio
country: United States
state: Texas
city: Toronto
country: Canada
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: