NCT01688960

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.)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2012

Typical duration for phase_1

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

September 17, 2012

Last Update Submit

March 16, 2015

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

    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

    Day 1 to Day 28

Secondary Outcomes (4)

  • Pharmacokinetics (PK)

    Day 1 to Day 170

  • Immunogenicity

    Day 1 to Day 170

  • Antitumor activity

    Day 1 to Day 170

  • Pharmacodynamics (PD)

    Day 1 to Day 170

Study Arms (5)

Cohort 1

EXPERIMENTAL
Drug: nesvacumab (REGN910/ SAR307746)Drug: aflibercept (ziv-aflibercept)

Cohort 2

EXPERIMENTAL
Drug: nesvacumab (REGN910/ SAR307746)Drug: aflibercept (ziv-aflibercept)

Cohort 3a

EXPERIMENTAL
Drug: nesvacumab (REGN910/ SAR307746)Drug: aflibercept (ziv-aflibercept)

Cohort 3b

EXPERIMENTAL
Drug: nesvacumab (REGN910/ SAR307746)Drug: aflibercept (ziv-aflibercept)

Cohort 4

EXPERIMENTAL
Drug: nesvacumab (REGN910/ SAR307746)Drug: aflibercept (ziv-aflibercept)

Interventions

nesvacumab (REGN910/ SAR307746)DRUG

Dose level 1

Cohort 1
aflibercept (ziv-aflibercept)DRUG

Dose level 1

Also known as: In US: aflibercept is known as ziv-aflibercept
Cohort 1Cohort 2Cohort 3a

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of solid tumor malignancy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hepatic, renal and bone marrow function
  • Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1

You may not qualify if:

  • Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
  • Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg
  • Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
  • Patients with deep vein thrombosis or pulmonary embolism within last 3 months
  • Patients with serious non healing wound or acute ulcer
  • 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
  • Patients with history of abdominal or tracheal-esophageal fistula
  • Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors
  • Prior treatment with bevacizumab within last 6 weeks
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Toronto, Canada

Location

MeSH Terms

Interventions

aflibercept

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(5)CA(1)