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Metastatic Pancreatic AdenocarcinomaPhase 1NCT01510561

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

A Phase 1 study testing 90Y-hPAM4 and 90Y-hPAM4 + gemcitabine in people with Metastatic Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Gilead Sciences at 24 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
90Y-hPAM4 and 90Y-hPAM4 + gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
24 sitesUnited States
Study dates
Mar 2012to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87131

  • Winship Cancer Institute

    Atlanta, Georgia, 30308

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27599

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Detroit Clinical Research Center

    Detroit, Michigan, 48377

  • Banner Healthcare

    Gilbert, Arizona, 85234

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • St. Mary's Trinity Healthcare

    Grand Rapids, Michigan, 49503

  • Institute of Translational Oncology Research

    Greenville, South Carolina, 29605

  • Sylvester Comprehensive Cancer Center Univ. Miami

    Miami, Florida, 33136

  • Jackson North Medical Center

    Miami, Florida, 33169

  • Weill Cornell NY Presbyterian Hospital

    New York, New York, 10021

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Health Services Helen Graham Cancer Center

    Newark, Delaware, 19713

  • VA Oncology Associates

    Norfolk, Virginia, 23502

  • Kimmel Cancer Center at Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85258

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Tyler Cancer Center

    Tyler, Texas, 75702

Other trials in United States

About this study

Official title: A Ph Ib 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.

Being tested
90Y-hPAM4, 90Y-hPAM4 + gemcitabine
Keywords
metastatic pancreatic adenocarcinoma, pancreatic cancer, metastatic pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 90Y-hPAM4Drug

    Also called Clivatuzumab Tetraxetan

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

  • 90Y-hPAM4Drug

    Also called clivatuzumab tetraxetan

  • 90Y-hPAM4 + gemcitabineDrug

    Also called gemzar, clivatuzumab tetraxetan

Study groups in NCT01510561
Study groupRoleWhat they receive
90Y-hPAM4Experimental90Y-hPAM4 is administered weekly for 3 weeks
Receives: Drug: 90Y-hPAM4
90Y-hPAM4 + gemcitabineExperimental90Y-hPAM4 is administered weekly for 3 weeks, while gemcitabine is administered weekly for 4 weeks.
Receives: Drug: 90Y-hPAM4; Drug: 90Y-hPAM4 + gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (2)

  1. 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.

    Measured: 2 years

  2. Efficacy

    Efficacy will be assessed for at least 1 year after treatment with study drug. CT scans will be used to determine treatment response.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionJun 2015 (estimated)
  4. Study completionSep 2015

Why it stopped: no subjects enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01510561
Sponsor's protocol ID
IM-T-hPAM4-03
Status last verified
Dec 2020
First submitted
5 Jan 2012
Last updated
19 Aug 2021
Results posted
No
Data monitoring committee
No

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.

    PubMed 26187510

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 90Y-hPAM4 and 90Y-hPAM4 + gemcitabine in people with Metastatic Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Gilead Sciences at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (change in hematology and chemistry laboratory values from baseline) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01510561, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

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