Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer (PANCRIT®-1)

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Metastatic Pancreatic Cancer; Pancreatic Cancer

Treatments: Drug: IMMU-107; Drug: placebo; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01956812

IMMU-107-04

Details and patient eligibility

About

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).

Enrollment: 334 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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334 participants in 2 patient groups

Arm A IMMU-107 and gemcitabine

Experimental group

Description:

IMMU-107 and low dose gemcitabine

Treatment:

Drug: Gemcitabine

Drug: IMMU-107

Arm B Placebo and low dose gemcitabine

Active Comparator group

Description:

Placebo and low dose gemcitabine

Treatment:

Drug: Gemcitabine

Drug: placebo