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

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00747734
First received: September 4, 2008
Last updated: April 18, 2011
Last verified: April 2011

September 4, 2008
April 18, 2011
September 2008
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Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Length of study ]
Complete list of historical versions of study NCT00747734 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
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A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors
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

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
Drug: MNRP1685A
Escalating intravenous dose
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00747734
ANP4509g
Not Provided
Disclosures Group, Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Rainer Brachmann, M.D. Genentech, Inc.
Genentech, Inc.
April 2011

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