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

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)

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).

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.