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

Solid Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747734
• Other study ID #: ANP4509g
• Status: Completed
• Phase: Phase 1
• First received: September 4, 2008
• Last updated: April 18, 2011
• Start date: September 2008

Study information

• Verified date: April 2011
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Cancers

Intervention

Drug:
• MNRP1685A
Escalating intravenous dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities (DLTs)		Length of study	No
Secondary	Total exposure (AUC)		Length of study	No
Secondary	Maximum and minimum serum concentrations		Length of study	No
Secondary	Clearance		Length of study	No
Secondary	Volume of distribution		Length of study	No