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)
Loading locations...
Similar Trials
Not yet recruiting
Phase 3
to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)Triple Negative Breast CancerNCT04301739Shanghai Henlius Biotech522
Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of FracturePostmenopausalNCT05352516Shanghai Henlius Biotech478
Withdrawn
Phase 3
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast CancerBreast CancerNCT03081234Novartis Pharmaceuticals
Recruiting
Phase 3
ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)Prostate Cancer MetastaticNCT04916613UNICANCER300
Completed
Phase 3
Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue SarcomaSoft Tissue SarcomaNCT01168791Alaunos Therapeutics447