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

Sponsor

Gilead Sciences (Industry)

Overall Status

Terminated

CT.gov ID

NCT01956812

Collaborator

(none)

334

Enrollment

Locations

Arms

Actual Duration (Months)

5.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Metastatic Pancreatic Cancer Pancreatic Cancer	Drug: IMMU-107 Drug: placebo Drug: Gemcitabine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

334 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A IMMU-107 and gemcitabine IMMU-107 and low dose gemcitabine	Drug: IMMU-107 Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles Other Names: 90Y-clivatuzumab tetraxetan Drug: Gemcitabine Gemcitabine, 200 mg/m2, given weekly x 4 in both arms Other Names: gemcitabine 200 mg/m2
Active Comparator: Arm B Placebo and low dose gemcitabine Placebo and low dose gemcitabine	Drug: placebo placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles Other Names: normal saline Drug: Gemcitabine Gemcitabine, 200 mg/m2, given weekly x 4 in both arms Other Names: gemcitabine 200 mg/m2

Arm

Intervention/Treatment

Experimental: Arm A IMMU-107 and gemcitabine

IMMU-107 and low dose gemcitabine

Drug: IMMU-107

Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles

Other Names:

90Y-clivatuzumab tetraxetan

Drug: Gemcitabine

Gemcitabine, 200 mg/m2, given weekly x 4 in both arms

Other Names:

gemcitabine 200 mg/m2

Active Comparator: Arm B Placebo and low dose gemcitabine

Placebo and low dose gemcitabine

Drug: placebo

placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles

Other Names:

normal saline

Drug: Gemcitabine

Gemcitabine, 200 mg/m2, given weekly x 4 in both arms

Other Names:

gemcitabine 200 mg/m2

Outcome Measures

Primary Outcome Measures

overall survival [24 months]

Secondary Outcome Measures

Overall survival [3, 6 and 12 months]
Objective tumor response [24 months]
Progression free survival [24 months]
Clinical benefit [24 months]
quality of life will be assessed over 24 months using the FACT-hepatopancreatic form

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner MD Anderson	Gilbert	Arizona	United States	85234
2	City of Hope National Medical Center	Duarte	California	United States	91010
3	Pacific Shores Medical Group	Long Beach	California	United States	90813
4	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
5	Whittingham Cancer Center	Norwalk	Connecticut	United States	06856
6	Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital	Fort Lauderdale	Florida	United States	33308
7	Baptist Cancer Institute	Jacksonville	Florida	United States	32207
8	Cancer Specialists of North Florida	Jacksonville	Florida	United States	32256
9	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho	United States	83712
10	Illinois Cancer Specialists	Arlington Heights	Illinois	United States	60005
11	Indiana University Health Goshen Center for Cancer Care	Goshen	Indiana	United States	46526
12	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
13	Ashland-Bellefonte Cancer Center	Ashland	Kentucky	United States	41101
14	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
15	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201
16	Henry Ford Health System	Detroit	Michigan	United States	48202
17	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States	55455
18	University of Mississippi Medical Center	Jackson	Mississippi	United States	39213
19	Oncology Hematology West P.C. dba Nebraska Cancer Specialists	Omaha	Nebraska	United States	68130
20	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89169
21	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
22	New York Presbyterian Hospital/Weill Cornell Medical Center	New York	New York	United States	10021
23	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
24	University of Rochester Medical Center	Rochester	New York	United States	14642
25	Stony Brook University Medical Center	Stony Brook	New York	United States	11794-7007
26	SUNY Upstate Medical University	Syracuse	New York	United States	13210
27	University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina	United States	27599-7510
28	The Ohio State University - Comprehensive Cancer Center	Columbus	Ohio	United States	43210
29	Stephenson Cancer Center	Oklahoma City	Oklahoma	United States	73104
30	The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
31	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104
32	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
33	University of Pittsburgh Medical Center/Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232
34	Center for Biomedical Research	Knoxville	Tennessee	United States	37909
35	University of Tennessee Medical Center, Cancer Institute	Knoxville	Tennessee	United States	37920
36	Mary Crowley Medical Research Center	Dallas	Texas	United States	75251
37	Oncology Consultants	Houston	Texas	United States	77030
38	Texas Oncology - McAllen	McAllen	Texas	United States	78503
39	Texas Oncology - Tyler	Tyler	Texas	United States	75702
40	Virginia Oncology Associates	Norfolk	Virginia	United States	23502
41	University of Washington	Seattle	Washington	United States	98109
42	Virginia Mason Medical Center	Seattle	Washington	United States	98111
43	Krankenhaus der Elisabethinen Linz	Linz		Austria	A-4020
44	Medical University Vienna	Vienna		Austria	1090
45	University Hospital Leuven	Leuven		Belgium	3000
46	Cancer Care Manitoba	Winnepeg	Manitoba	Canada	R3E 0V9
47	Centre Hospitalier Université de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4
48	ICO René Gauducheau	Nantes	Cedex 1	France	44093
49	Institut Paoli-Calmettes	Marseille	Cedex 9	France	13273
50	Institut Bergonie	Bordeaux	Cedex	France	33076
51	Centre Léon Bérard Cancerologie Medicale	Lyon		France	69008
52	Institut Paoli-Calmettes	Marseille		France	13273
53	CRLC Val D'Aurelle	Montpellier Cedex 5		France	34298
54	CRLC Val D'Aurelle	Montpellier		France	34298
55	Hopital Cochin	Paris		France	75014
56	Soroka Medical Center	Beer Sheva		Israel	84101
57	Rambam Medical Center	Haifa		Israel	3109601
58	Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa	Warszawa		Poland	02-781
59	Hospital Sant Joan de Reu	Reus	Tarragona	Spain	43204
60	Hospital Vall D'Hebrón	Barcelona		Spain	08035
61	Hospital Universitario Gregorio Marañón	Madrid		Spain	28007
62	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
63	Hospital Universitario La Paz	Madrid		Spain	28046
64	Centro Integral Oncologico Clara Campal	Madrid		Spain	28050
65	Hospital Miguel Servet	Zaragoza		Spain	50009