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Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer (PANCRIT®-1)

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ClinicalTrials.gov Identifier: NCT01956812
Recruitment Status : Terminated (The DSMB conducted an interim analysis on overall survival, which showed that the treatment arm did not demonstrate a sufficient improvement in OS vs. placebo.)
First Posted : October 8, 2013
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Study Description
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Brief Summary:
The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Pancreatic Cancer Drug: IMMU-107 Drug: placebo Drug: Gemcitabine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)
Actual Study Start Date : December 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A IMMU-107 and gemcitabine
IMMU-107 and low dose gemcitabine
 Drug: IMMU-107
Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles
Other Name: 90Y-clivatuzumab tetraxetan

Drug: Gemcitabine
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
Other Name: gemcitabine 200 mg/m2
Active Comparator: Arm B Placebo and low dose gemcitabine
Placebo and low dose gemcitabine
 Drug: placebo
placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles
Other Name: normal saline

Drug: Gemcitabine
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
Other Name: gemcitabine 200 mg/m2


Outcome Measures
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Primary Outcome Measures :
  1. overall survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3, 6 and 12 months ]
  2. Objective tumor response [ Time Frame: 24 months ]
  3. Progression free survival [ Time Frame: 24 months ]
  4. Clinical benefit [ Time Frame: 24 months ]
    quality of life will be assessed over 24 months using the FACT-hepatopancreatic form


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Metastatic disease
  • Received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease.
  • At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria:
  • Completed at least one cycle of the treatment
  • Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment
  • Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine
  • Progression was documented,
  • Preferentially radiologically by tumor growth or new lesions, or by
  • Clear symptomatic deterioration supported by at least two of the following clinical criteria: ≥ 10% worsening in KPS or ≥ 1 worsening in ECOG; increasing weakness or fatigue; progressive weight loss; new/worsening pain requiring increased pain medication; new/worsening jaundice, nausea, or vomiting; new/worsening ascites or pleural effusions; other physical or laboratory findings consistent with disease progression.
  • KPS >/= 70
  • Adequate bone marrow function
  • Adequate hepatic function
  • Adequate renal function

Exclusion Criteria:

  • CNS metastatic disease

  • Bulky disease (any single mass >10 cm).

    ->Grade 2 nausea or vomiting, and/or signs of intestinal obstruction.

  • Prior external beam irradiation to a field that includes more than 30% of the red bone marrow.
  • Patients with clinically significant severe cardiorespiratory disease.

Please consult with the clinical trial site for the full detailed list of specific inclusion/exclusion criteria.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956812


Locations
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Sponsors and Collaborators
Immunomedics, Inc.
Investigators
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Study Chair: William Wegener, MD, PhD Immunomedics, Inc.
More Information
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Publications:

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Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT01956812    
Other Study ID Numbers: IMMU-107-04
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Keywords provided by Immunomedics, Inc.:
clivatuzumab tetraxetan
90Y-clivatuzumab tetraxetan
IMMU-107
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs