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

October 27, 2014 updated by: Prof.dr. E.G.E. de Vries, University Medical Center Groningen

89Zr-MMOT0530A PET Imaging in Patients With Unresectable Pancreatic or Platinum-resistant Ovarian Cancer Before Treatment With DMOT4039A. A Separate Study to the Phase I Study Protocol DMO4993g

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 cancer. MMOT0530A is a monoclonal antibody that targets an antigen overexpressed in pancreatic and ovarian cancer. Subsequent to imaging with 89Zr-MMOT0530A, patients will be treated with DMOT4039A in the DMO4993g protocol (clinicaltrials.gov identifier NCT01469793) after this study. DMOT4039A is an antibody-drug conjugate composed of the monoclonal antibody MMOT0530A and the mitotic agent monomethyl auristatin (MMAE). By imaging patients with the monoclonal antibody MMOT0530A before treatment, the correlation between tumor uptake of 89Zr-MMOT0530A and response to DMOT4039A therapy will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 presence or absence of the target is essential for the therapeutic effect of the newly developed drugs. DMOT0439A is one of those novel designed molecular targeted drugs; an antibody-drug conjugate composed of the monoclonal antibody MMOT0530A and the mitotic agent monomethyl auristatin (MMAE). In the DMO4993g protocol (clinicaltrials.gov identifier NCT01469793), the safety and efficacy of DMOT4039A is assessed in patients with unresectable pancreatic or platinum-resistant ovarian cancer. By performing a 89Zr-MMOT0530A PET scan prior to treatment with DMOT4039A, the uptake of the tracer in the primary and metastatic tumor lesions can be evaluated. This is likely to provide important information about target expression, whole body drug distribution and the correlation between tumor uptake and response to therapy. Ultimately the use of a 89Zr- MMOT0530A PET as a complimentary tool for patient selection and risk stratification can be evaluated. In part A of this study, the optimal tracer dose of 89Zr- MMOT0530A and schedule for PET imaging will be determined. In part B patients will have PET imaging before treatment in the DMO4993g study on the dose and time points as assessed in part A.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081HV
        • VU Medical Center
      • Groningen, Netherlands, 9713GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tracerinjection
Injection of 89Zr-MMOT0530A followed by 2 or 3 PET scans at different time points
Drug: 89Zr-MMOT0530A
Injection of 89Zr-MMOT0530A followed by 2 or 3 PET scans at different time points
Other Names:
  • MMOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The in vivo biodistribution measured in SUV values and organ pharmacokinetics (PK) of 89Zr-MMOT0530A
Time Frame: Approximately 1 year
  • The accumulation, distribution and localization of 89Zr-MMOT0530A in tumor tissue, organs and blood circulation, as assessed by PET.
  • The quantitative uptake of 89Zr-MMOT0530A expressed in SUV (Standardized Uptake value).
Approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 89Zr-MMOT0530A tumor uptake measured in SUV related to the response to DMOT4039A therapy according to RECISt 1.1 criteria
Time Frame: Approximately 1 year
The correlation between the 89Zr-MMOT0530A tumor uptake and response to therapy by performing an 89Zr-MMOT0530A PET scan before DMOT4039A therapy, related to CT/MRI response according to RECIST 1.1 criteria.
Approximately 1 year
Number of patients with adverse events after 89Zr-MMOT0530A injection as a measure of safety and tolerability
Time Frame: Approximately 1 year
Safety will be assessed by evaluation of incidence of adverse events.
Approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Genentech, Inc.
Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: Elisabeth G. de Vries, MD PhD, University Medical Center Groningen
  • Principal Investigator: Henk M Verheul, MD PhD, Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMOT imaging

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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