Status:

COMPLETED

89Zr-MMOT PET Imaging in Pancreatic and Ovarian Cancer Patients

Lead Sponsor:

University Medical Center Groningen

Collaborating Sponsors:

Amsterdam UMC, location VUmc

Genentech, Inc.

Conditions:

Ovarian Neoplasms

Ovarian Diseases

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

The purpose of this multicenter imaging sub study is to evaluate the biodistribution and organ pharmacokinetics of 89Zr-MMOT0530A in patients with unresectable pancreatic or platinum-resistant ovarian...

Detailed Description

A challenge in current drug development using molecular targeted therapies is the high level of heterogeneity that is present in specific tumor types. The ability to safely and accurately predict the ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Adult patients, \>/= 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer
  • Measureable disease, defined as at least one bi-dimensionally measurable non-lymph node lesion \>/= 1 cm in long-axis diameter on spiral CT scan or at least one bi-dimensionally measurable lymph node measuring \>/= 1.5 cm in short-axis diameter on spiral CT scan
  • Adequate hematological, renal and liver function
  • Exclusion criteria:
  • Treatment with anti-tumor therapy, including chemotherapy, biologic, experimental or hormonal therapy, within 4 weeks prior to Day 1
  • Known active infection
  • Current Grade \>/= 2 toxicity (except for alopecia, anorexia and fatigue) from prior therapy or Grade \>/= 2 neuropathy
  • Untreated or active cerebral nervous system (CNS) metastases
  • Pregnant or breastfeeding women

Exclusion

    Key Trial Info

    Start Date :

    March 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2014

    Estimated Enrollment :

    11 Patients enrolled

    Trial Details

    Trial ID

    NCT01832116

    Start Date

    March 1 2013

    End Date

    May 1 2014

    Last Update

    May 3 2024

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    VU Medical Center

    Amsterdam, Netherlands, 1081HV

    2

    University Medical Center Groningen

    Groningen, Netherlands, 9713GZ