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

NCT01832116CompletedPHASE1INTERVENTIONAL

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.

Key Facts

Lead Sponsor

University Medical Center Groningen

Enrollment

Start Date

2013-03-01

Completion Date

2014-05-01

Study Type

INTERVENTIONAL

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

Interventions

89Zr-MMOT0530A

Conditions

Ovarian NeoplasmsOvarian DiseasesAdnexal DiseasesPancreatic NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPancreatic Diseases

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

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

* 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).

Time frame: Approximately 1 year

Secondary Outcomes

The 89Zr-MMOT0530A tumor uptake measured in SUV related to the response to DMOT4039A therapy according to RECISt 1.1 criteria

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.

Time frame: Approximately 1 year

Number of patients with adverse events after 89Zr-MMOT0530A injection as a measure of safety and tolerability

Safety will be assessed by evaluation of incidence of adverse events.

Time frame: Approximately 1 year

Locations

VU Medical Center, Amsterdam, Netherlands

University Medical Center Groningen, Groningen, Netherlands

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.