Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Metastatic Pancreatic Cancer, Pancreatic Cancer

Intervention / Treatment
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* Drug: IMMU-107
* Drug: placebo
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A IMMU-107 and gemcitabine<br>IMMU-107 and low dose gemcitabine | Drug: IMMU-107<br>* Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles<br>* Other names: 90Y-clivatuzumab tetraxetan;Drug: Gemcitabine<br>* Gemcitabine, 200 mg/m2, given weekly x 4 in both arms<br>* Other names: gemcitabine 200 mg/m2;|
| Active Comparator: Arm B Placebo and low dose gemcitabine<br>Placebo and low dose gemcitabine | Drug: placebo<br>* placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles<br>* Other names: normal saline;Drug: Gemcitabine<br>* Gemcitabine, 200 mg/m2, given weekly x 4 in both arms<br>* Other names: gemcitabine 200 mg/m2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clivatuzumab tetraxetan, 90Y-clivatuzumab tetraxetan, IMMU-107