A Study Of Fractionated 90Y-hPAM4 Plus Gemcitabine In Pancreatic Cancer Patients Receiving At Least 2 Prior Therapies.

Study Overview

A Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Pancreatic Cancer Patients Receiving at Least 2 Prior Therapies.

90Y-hPAM4 is administered weekly for 3 weeks combined with 4 weekly doses of gemcitabine to assess. This is a dose escalation study of 90Y-hPAM4 to assess which dose is safe and effective as 3rd line treatment for patients with metastatic pancreatic cancer. Patients are then followed weekly for 12 weeks and afterwards for up to 1 year.

N/A

Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer
Metastatic Pancreatic Cancer

DRUG: 90Y-hPAM4
DRUG: 90Y-hPAM4
DRUG: 90Y-hPAM4 + gemcitabine

IM-T-hPAM4-03

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-01-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-08-12
First Submitted that Met QC Criteria 2012-01-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-08-19
First Posted (ACTUAL) 2012-01-16	Results First Posted N/A	Last Verified 2020-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 90Y-hPAM4 90Y-hPAM4 is administered weekly for 3 weeks	DRUG: 90Y-hPAM4 90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4. DRUG: 90Y-hPAM4 DRUG: 90Y-hPAM4 + gemcitabine
EXPERIMENTAL: 90Y-hPAM4 + gemcitabine 90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.	DRUG: 90Y-hPAM4 90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4. DRUG: 90Y-hPAM4 DRUG: 90Y-hPAM4 + gemcitabine

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 90Y-hPAM4

90Y-hPAM4 is administered weekly for 3 weeks

DRUG: 90Y-hPAM4

90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.

DRUG: 90Y-hPAM4

DRUG: 90Y-hPAM4 + gemcitabine

EXPERIMENTAL: 90Y-hPAM4 + gemcitabine

90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.

DRUG: 90Y-hPAM4

90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.

DRUG: 90Y-hPAM4

DRUG: 90Y-hPAM4 + gemcitabine

Primary Outcome Measures	Measure Description	Time Frame
Safety (change in hematology and chemistry laboratory values from baseline)	Acute safety will be assessed weekly for the 1st 12 weeks, and then for up to 1 year after completion of study drug treatment. Safety will be assessed by comparing baseline hematology and chemistry laboratory values with the values obtained weekly after treatment. Safety will also be assessed by the adverse events that are reported.	1 year

Secondary Outcome Measures	Measure Description	Time Frame
Dosage determination	This study is also being done to determine an acceptable 90Y-hPAM4 dose in this patient population. It is anticipated that enrollment will occur over 2 years.	2 years
Efficacy	Efficacy will be assessed for at least 1 year after treatment with study drug. CT scans will be used to determine treatment response.	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Male or female patients, ≥ 18 years of age, who are able to understand and give written informed consent
Histologically or cytologically confirmed pancreatic adenocarcinoma
Stage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections
Previously treated and received two prior treatment regimens for advanced disease
Karnofsky performance status ≥ 60 % (Appendix A)
Expected survival ≥ 3 months
At least 4 weeks beyond major surgery, 2 weeks beyond chemotherapy, radiotherapy, other experimental treatments
At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis
Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3)
Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN [5.0 X IULN if due to liver metastases])
Otherwise, all toxicity at study entry ≤ Grade 1 by NCI CTC v3.0 or recovered to baseline or discussed with and agreed to with Immunomedics' Medical Monitor.

Women who are pregnant or lactating
Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period
Known metastatic disease to the central nervous system
Presence of bulky disease (defined as any single mass > 10 cm in its greatest dimension)
Patients with > Grade 2 nausea or vomiting and/or signs of intestinal obstruction
Prior radiation dose > 3,000 cGy to the liver, > 2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow
Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 3-year disease free interval
Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive
Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months, or cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy
Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months
Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids)
Infection requiring intravenous antibiotic use within 1 week
Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: William A Wegener, MD, PhD, Gilead Sciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Picozzi VJ, Ramanathan RK, Lowery MA, Ocean AJ, Mitchel EP, O'Neil BH, Guarino MJ, Conkling PR, Cohen SJ, Bahary N, Frank RC, Dragovich T, Bridges BB, Braiteh FS, Starodub AN, Lee FC, Gribbin TE, Richards DA, Lee M, Korn RL, Pandit-Taskar N, Goldsmith SJ, Intenzo CM, Sheikh A, Manzone TC, Horne H, Sharkey RM, Wegener WA, O'Reilly EM, Goldenberg DM, Von Hoff DD. (90)Y-clivatuzumab tetraxetan with or without low-dose gemcitabine: A phase Ib study in patients with metastatic pancreatic cancer after two or more prior therapies. Eur J Cancer. 2015 Sep;51(14):1857-64. doi: 10.1016/j.ejca.2015.06.119. Epub 2015 Jul 14.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record