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

This study has been completed.
Sponsor:
Collaborators:
VU University Medical Center
Genentech
Information provided by (Responsible Party):
Prof.dr. E.G.E. de Vries, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01832116
First received: April 2, 2013
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Pancreatic Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases
Drug: 89Zr-MMOT0530A
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • The in vivo biodistribution measured in SUV values and organ pharmacokinetics (PK) of 89Zr-MMOT0530A [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
    • 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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Number of patients with adverse events after 89Zr-MMOT0530A injection as a measure of safety and tolerability [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]
    Safety will be assessed by evaluation of incidence of adverse events.


Enrollment: 11
Study Start Date: March 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MMOT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832116

Locations
Netherlands
VU Medical Center
Amsterdam, Netherlands, 1081HV
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
University Medical Centre Groningen
VU University Medical Center
Genentech
Investigators
Principal Investigator: Elisabeth G. de Vries, MD PhD University Medical Centre Groningen
Principal Investigator: Henk M Verheul, MD PhD VU University Medical Center
  More Information

No publications provided

Responsible Party: Prof.dr. E.G.E. de Vries, MD PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01832116     History of Changes
Other Study ID Numbers: MMOT imaging
Study First Received: April 2, 2013
Last Updated: May 22, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
Pancreatic cancer
Ovarian cancer

Additional relevant MeSH terms:
Adnexal Diseases
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Digestive System Neoplasms
Gastrointestinal Neoplasms
Ovarian Neoplasms
Ovarian Diseases
Pancreatic Diseases
Pancreatic Neoplasms
Genital Diseases, Female
Neoplasms by Site
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 23, 2014