Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer (PANCRIT®-1)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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 : August 16, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Pancreatic Cancer Pancreatic Cancer | Drug: IMMU-107 Drug: placebo Drug: Gemcitabine | Phase 3 |
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 |

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 |
- overall survival [ Time Frame: 24 months ]
- Overall survival [ Time Frame: 3, 6 and 12 months ]
- Objective tumor response [ Time Frame: 24 months ]
- Progression free survival [ Time Frame: 24 months ]
- Clinical benefit [ Time Frame: 24 months ]quality of life will be assessed over 24 months using the FACT-hepatopancreatic form

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

Study Chair: | William Wegener, MD, PhD | Gilead Sciences |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01956812 |
Other Study ID Numbers: |
IMMU-107-04 |
First Posted: | October 8, 2013 Key Record Dates |
Last Update Posted: | August 16, 2021 |
Last Verified: | March 2020 |
clivatuzumab tetraxetan 90Y-clivatuzumab tetraxetan IMMU-107 |
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 |