Metastatic Pancreatic Cancer, Pancreatic Cancer
Conditions
Keywords
clivatuzumab tetraxetan, 90Y-clivatuzumab tetraxetan, IMMU-107
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).
Interventions
DRUGIMMU-107
Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles
DRUGplacebo
placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles
DRUGGemcitabine
Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3, 6 and 12 months | — |
| Objective tumor response | 24 months | — |
| Progression free survival | 24 months | — |
| Clinical benefit | 24 months | quality of life will be assessed over 24 months using the FACT-hepatopancreatic form |
Countries
Austria, Belgium, Canada, France, Israel, Poland, Spain, United States
Outcome results
None listed