NCT01956812TerminatedPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Gilead Sciences
- Enrollment
- 334
- Locations
- 63
- Primary Endpoint
- overall survival
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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/exclusion criteria.
Arms & Interventions
Arm A IMMU-107 and gemcitabine
Experimental
IMMU-107 and low dose gemcitabine
Intervention: IMMU-107 (Drug)
Arm A IMMU-107 and gemcitabine
Experimental
IMMU-107 and low dose gemcitabine
Intervention: Gemcitabine (Drug)
Arm B Placebo and low dose gemcitabine
Active Comparator
Placebo and low dose gemcitabine
Intervention: placebo (Drug)
Arm B Placebo and low dose gemcitabine
Active Comparator
Placebo and low dose gemcitabine
Intervention: Gemcitabine (Drug)
Outcomes
Primary Outcomes
overall survival
Time Frame: 24 months
Secondary Outcomes
- Objective tumor response(24 months)
- Clinical benefit(24 months)
- Overall survival(3, 6 and 12 months)
- Progression free survival(24 months)
Investigators
Study Sites (63)
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