Overview

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

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Medical Center Groningen
Collaborators:
Genentech, Inc.
VU University Medical Center
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