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

NCT00747734 | Completed Phase 1

• 1 other identifier: ANP4509g
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Solid Cancers

Keywords

Neuropilin-1; NRP1; anti-NRP1; anti-angiogenic

Outcome Measures

Primary Outcomes (1)

• Incidence and nature of dose-limiting toxicities (DLTs)

  Length of study

Secondary Outcomes (4)

• Total exposure (AUC)

  Length of study

• Maximum and minimum serum concentrations

  Length of study

• Clearance

  Length of study

• Volume of distribution

  Length of study

Interventions

MNRP1685A DRUG

Escalating intravenous dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Interventions

vesencumab

Study Officials

• Rainer Brachmann, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: September 1, 2008
• Last Updated: April 20, 2011

Record last verified: 2011-04