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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.
ClinicalTrials.gov Identifier: NCT00747734
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : April 20, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Solid Cancers Drug: MNRP1685A Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2008

Intervention Details:
  • Drug: MNRP1685A
    Escalating intravenous dose

Primary Outcome Measures :
  1. Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Total exposure (AUC) [ Time Frame: Length of study ]
  2. Maximum and minimum serum concentrations [ Time Frame: Length of study ]
  3. Clearance [ Time Frame: Length of study ]
  4. Volume of distribution [ Time Frame: Length of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747734

Sponsors and Collaborators
Genentech, Inc.
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Study Director: Rainer Brachmann, M.D. Genentech, Inc.
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Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00747734    
Other Study ID Numbers: ANP4509g
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: April 2011
Keywords provided by Genentech, Inc.: