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OpenTrials
Completed

NCT Number: NCT00747734

A Study of MNRP1685A 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.

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Key information

Conditions

Solid Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MNRP1685A

Drug

Escalating intravenous dose

Primary outcomes

  1. Incidence and nature of dose-limiting toxicities (DLTs)

    Time frame: Length of study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
First posted
Sep 5, 2008
Registry last updated
Apr 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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