NCT01832116

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

April 2, 2013

Last Update Submit

May 2, 2024

Conditions

Ovarian NeoplasmsOvarian DiseasesAdnexal DiseasesPancreatic NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPancreatic Diseases

Keywords

Pancreatic cancerOvarian cancer

Outcome Measures

Primary Outcomes (1)

  • 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).

    Approximately 1 year

Secondary Outcomes (2)

  • The 89Zr-MMOT0530A tumor uptake measured in SUV related to the response to DMOT4039A therapy 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

    Approximately 1 year

Study Arms (1)

Tracerinjection

EXPERIMENTAL

Injection of 89Zr-MMOT0530A followed by 2 or 3 PET scans at different time points

Drug: 89Zr-MMOT0530A

Interventions

89Zr-MMOT0530ADRUG

Injection of 89Zr-MMOT0530A followed by 2 or 3 PET scans at different time points

Also known as: MMOT
Tracerinjection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VU Medical Center

Amsterdam, 1081HV, Netherlands

Location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

MeSH Terms

Conditions

Ovarian NeoplasmsOvarian DiseasesAdnexal DiseasesPancreatic NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPancreatic Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Elisabeth G. de Vries, MD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

  • Henk M Verheul, MD PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 15, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 3, 2024

Record last verified: 2024-05

Locations

NL(2)