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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

Phase 1
18 Years
Open (Enrolling)
Ovarian Neoplasms, Ovarian Diseases, Adnexal Diseases, Pancreatic Neoplasms, Digestive System Neoplasms, Digestive System Diseases, Pancreatic Diseases

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Trial Information

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

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 (
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.

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

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The in vivo biodistribution measured in SUV values and organ pharmacokinetics (PK) of 89Zr-MMOT0530A

Outcome Description:

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).

Outcome Time Frame:

Approximately 1 year

Safety Issue:


Principal Investigator

Elisabeth G. de Vries, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Groningen


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MMOT imaging



Start Date:

March 2013

Completion Date:

May 2014

Related Keywords:

  • Ovarian Neoplasms
  • Ovarian Diseases
  • Adnexal Diseases
  • Pancreatic Neoplasms
  • Digestive System Neoplasms
  • Digestive System Diseases
  • Pancreatic Diseases
  • Pancreatic cancer
  • Ovarian cancer
  • Adnexal Diseases
  • Neoplasms
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms
  • Ovarian Neoplasms
  • Ovarian Diseases
  • Pancreatic Diseases
  • Pancreatic Neoplasms