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

This study has been completed.
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
First received: September 4, 2008
Last updated: April 18, 2011
Last verified: April 2011
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.

Condition Intervention Phase
Solid Cancers
Drug: MNRP1685A
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total exposure (AUC) [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Maximum and minimum serum concentrations [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Clearance [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Volume of distribution [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: September 2008
Intervention Details:
    Drug: MNRP1685A
    Escalating intravenous dose

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747734

Sponsors and Collaborators
Genentech, Inc.
Study Director: Rainer Brachmann, M.D. Genentech, Inc.
  More Information

Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00747734     History of Changes
Other Study ID Numbers: ANP4509g 
Study First Received: September 4, 2008
Last Updated: April 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:

ClinicalTrials.gov processed this record on May 26, 2016