A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors

This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States.

Study Overview

• Status: Completed
• Conditions: Solid Cancers
• Intervention / Treatment: Drug: MNRP1685A

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years
• Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen
• Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease)

Exclusion Criteria:

• Inadequate hematologic or organ function
• Anti-cancer therapy within 4 weeks prior to initiation of study treatment
• Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders
• Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava
• Active infection or autoimmune disease
• Known human immunodeficiency virus (HIV) infection
• Pregnancy or breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and nature of dose-limiting toxicities (DLTs)	Length of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Total exposure (AUC)	Length of study
Maximum and minimum serum concentrations	Length of study
Clearance	Length of study
Volume of distribution	Length of study

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2008

Study Registration Dates

• First Submitted: September 4, 2008
• First Submitted That Met QC Criteria: September 4, 2008
• First Posted (ESTIMATE): September 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 20, 2011
• Last Update Submitted That Met QC Criteria: April 18, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: anti-angiogenic; Neuropilin-1; NRP1; anti-NRP1
• Other Study ID Numbers: ANP4509g