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

Phase 1

Completed

• Conditions: Solid Cancers

• Registration Number: NCT00747734
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-18
• Last Update Posted: 2011-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence and nature of dose-limiting toxicities (DLTs)	Length of study

Secondary Outcome Measures

Name	Time	Method
Total exposure (AUC)	Length of study
Maximum and minimum serum concentrations	Length of study
Clearance	Length of study
Volume of distribution	Length of study