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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747734
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : April 20, 2011
Information provided by:
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE September 4, 2008
First Posted Date  ICMJE September 5, 2008
Last Update Posted Date April 20, 2011
Study Start Date  ICMJE September 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Length of study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
  • Total exposure (AUC) [ Time Frame: Length of study ]
  • Maximum and minimum serum concentrations [ Time Frame: Length of study ]
  • Clearance [ Time Frame: Length of study ]
  • Volume of distribution [ Time Frame: Length of study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Cancers
Intervention  ICMJE Drug: MNRP1685A
Escalating intravenous dose
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2010)
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2008)
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
Administrative Information
NCT Number  ICMJE NCT00747734
Other Study ID Numbers  ICMJE ANP4509g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Disclosures Group, Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rainer Brachmann, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP