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

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.