NCT01040000

Brief Summary

The purpose of the phase 2 component of this study is to determine if giving the immune molecule NPC-1C to individuals who have cancer of the pancreas or gastrointestinal tract (colon or rectum) which has not responded to standard treatments can shrink or halt the growth of cancer, and to obtain additional data to study its effect on the immune system. Safety data will also be accumulated and evaluated during this study. NPC-1C is a monoclonal antibody that recognizes a specific tumor target on certain cancers. In laboratory studies, the antibody killed tumor cells in some colon and pancreatic cancers that express the NPC-1C antigen by a process called "antibody-dependent cell cytotoxicity" or ADCC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_1

Geographic Reach
1 country

6 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

First Submitted

Initial submission to the registry

December 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

5.2 years

First QC Date

December 23, 2009

Last Update Submit

August 3, 2017

Conditions

Metastatic Pancreatic CancerMetastatic Colorectal Cancer

Keywords

NPC-1CMonoclonal antibodyPancreatic CancerAdenocarcinoma of the pancreasDuctal carcinoma of the pancreasDuct cell carcinomas, pancreasCarcinomas, pancreas duct cellPancreas duct cell carcinomaPancreatic duct cell carcinomaAdenocarcinoma of the colonAdenocarcinoma of the rectumColorectal cancerColorectal tumorColorectal neoplasm

Outcome Measures

Primary Outcomes (2)

  • Efficacy will be assessed by analysis of CT scans pre and post therapy, clinical laboratory tests, and physical examinations.

    10 weeks

  • Efficacy OS

    Using the recommended phase 2 dose (RP2D) evaluate the overall survival (OS) associated with administration of NPC-1C (NEO-102) in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer or metastatic colorectal cancer that express NPC-1C target on tumor.

    5 months

Secondary Outcomes (2)

  • Safety will be assessed by analysis of adverse experiences, clinical laboratory tests, and physical examinations.

    10 weeks

  • Pharmacokinetics and select immune responses to the antibody will be assessed.

    10 weeks

Study Arms (1)

NPC-1C/NEO-102

EXPERIMENTAL
Drug: NPC-1C/NEO-102

Interventions

NPC-1C/NEO-102DRUG

Subjects will receive NPC-1C at a dose of 3.0 mg/kg. NPC-1C will be given intravenously (by vein) over approximately 1-6 hours, once every 2 weeks for 4 doses per course. Courses will be repeated in the absence of disease progression or unacceptable toxicity.

Also known as: Ensituximab
NPC-1C/NEO-102

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: \>/= 18
  • Diagnosis:
  • Histologically confirmed recurrent, locally advanced unresectable or metastatic adenocarcinoma of the pancreas who have progressed after front line chemotherapy, OR
  • Histologically confirmed metastatic colorectal adenocarcinoma who have progressed after at least 2 standard chemotherapy regimens.
  • Tumor sections must stain \>/= 20% positive for NPC-1C antibody/antigen target
  • Measurable disease (by RECIST)
  • Karnofsky performance status of \>/= 50%
  • Laboratory Function (within 21 days of receiving first dose of study drug):
  • Hemoglobin \> 8.5 g/dL, or on stable doses (hematocrit stable within 1 gram and dose stable for one month) of erythropoietin or similar medication.
  • Absolute neutrophil count (ANC) \>/= 1,500/mm3
  • Platelets \>/= 50,000/mm3
  • Total bilirubin \</= 2.0 mg/dL
  • ALT and AST \</= 2.5 times the ULN, or, if the patient has liver metastases, \</= 5 times the ULN
  • Creatinine \</= ULN
  • Voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care.
  • +2 more criteria

You may not qualify if:

  • Has history of disseminated or uncontrolled brain metastases or central nervous system disease.
  • Ascites with abdominal distention.
  • Mechanical, non-reversible reason for not being able to eat, or have a likelihood of developing malignant bowel obstruction during the course of the induction phase of treatment; subjects with uncomplicated J-tubes will not be excluded.
  • Any major surgery within four weeks of enrollment.
  • Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Has another serious medical illness, including a second malignancy, or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • Pregnant or breast-feeding.
  • Any chemotherapeutic agents or corticosteroids within 2 weeks of study entry or biologic treatment within 4 weeks of study entry.
  • Use of any high risk medications that prolong the QT/QTc interval.
  • History of allergic reaction to Erbitux greater than grade 1.
  • Uncontrolled diabetes.
  • Prior history of a documented hemolytic event.
  • Receiving warfarin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Johns Hopkins Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9179, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsColorectal NeoplasmsCarcinoma, Pancreatic DuctalColonic NeoplasmsRectal Neoplasms

Interventions

ensituximab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Philip M Arlen, M.D.

    Precision Biologics, Inc

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 25, 2009

Study Start

January 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 4, 2017

Record last verified: 2017-08

Locations

US(6)