A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AbbVie
Study ID
NCT03368859
Phase
PHASE2
Status
Terminated

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Leucovorin — DRUG
    Intravenous
  • Fluorouracil - bolus — DRUG
    Intravenous
  • Bevacizumab — DRUG
    Intravenous
  • Fluorouracil - infusion — DRUG
    Intravenous
  • ABT-165 — DRUG
    Intravenous
  • Irinotecan — DRUG
    Intravenous

Study Details

A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.

Key Dates

Start date
Mar 20, 2018
Status verified
Jan 2021
Primary completion
Dec 18, 2019
Completion
Dec 18, 2019

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ABT-165 plus FOLFIRI
    ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
  • Active Comparator: Bevacizumab plus FOLFIRI
    Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Follow up continued until the first occurrence of radiographic progression, death from any cause or termination of the study; median follow-up time was 25.6(0.3-64.4) and 37.6(0.3-66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab + FOLFIRI, respectively ]

Locations (46)

FacilityCityStateZIPSite coordinators
Ironwood Cancer & Res Ctr /ID# 200044ChandlerArizona85224-5665-
Highlands Oncology Group /ID# 169289FayettevilleArkansas72703-4005-
City of Hope /ID# 200501DuarteCalifornia91010-
St. Joseph Heritage Healthcare /ID# 200100FullertonCalifornia92835-
USC Norris Cancer Center /ID# 200410Los AngelesCalifornia90033-
Hoag Memorial Hosp Presbyterian /ID# 202661Newport BeachCalifornia92663-
Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488Redondo BeachCalifornia90277-3036-
UC Davis Comprehensive Cancer Center - Main /ID# 207227SacramentoCalifornia95817-
Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215San Luis ObispoCalifornia93401-7068-
Central Coast Medical Oncology /ID# 200227Santa MariaCalifornia93454-5909-
University of California, Los /ID# 169294Santa MonicaCalifornia90404-
Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801AuroraColorado80014-
Georgetown University Hospital /ID# 202903Washington D.C.District of Columbia20007-
Florida Cancer Specialist - South /ID# 203796Fort MyersFlorida33901-8108-
Florida Cancer Specialists-Panhandle /ID# 203787TallahasseeFlorida32308-5304-
IACT Health /ID# 169292ColumbusGeorgia31904-8946-
Ingalls Memorial Hosp /ID# 169892HarveyIllinois60426-
Illinois Cancer Care, PC /ID# 202189PeoriaIllinois61615-
Fort Wayne Medical Oncology /ID# 201616Fort WayneIndiana46804-
Cancer Center of Kansas /ID# 200627WichitaKansas67214-
Norton Cancer Institute /ID# 200674LouisvilleKentucky40207-
Ochsner Clinic Foundation-New Orleans /ID# 169291New OrleansLouisiana70121-
Whiteside Institute for Clinic /ID# 200802DuluthMinnesota55805-
Mmcorc /Id# 202099Saint Louis ParkMinnesota55416-
Washington University School /ID# 200621St LouisMissouri63108-
University of Nebraska /ID# 203195OmahaNebraska68198-
The Valley Hospital /ID# 169999ParamusNew Jersey07652-
Duke University Medical Center /ID# 169657DurhamNorth Carolina27710-3000-
Cleveland Clinic Main Campus /ID# 200325ClevelandOhio44195-
Fairview Hospital - Moll Pavilion /ID# 205910ClevelandOhio44111-5605-
Hillcrest Hospital /ID# 205911Mayfield HeightsOhio44124-
INTEGRIS Cancer Institute /ID# 200832Oklahoma CityOklahoma73142-
INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831Oklahoma CityOklahoma73109-3411-
Oregon Health and Science University /ID# 170807PortlandOregon97239-
Thomas Jefferson University /ID# 200833PhiladelphiaPennsylvania19107-4414-
UPMC Hillman Cancer Ctr /ID# 200672PittsburghPennsylvania15232-
Greenville Hospital System /ID# 203021GreenvilleSouth Carolina29605-
Tennessee Oncology-Nashville Centennial /ID# 203424NashvilleTennessee37203-1632-
Tennessee Oncology, PLLC /ID# 203581NashvilleTennessee37203-
Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112DallasTexas75235-7709-
UTSW-Dallas /ID# 204031DallasTexas75390-
Millennium Oncology /ID# 204925HoustonTexas77090-1243-
Virginia Cancer Specialists /ID# 169293FairfaxVirginia22031-
Kadlec Clinic Hematology and O /ID# 170811KennewickWashington99336-
Medical Oncology Associates /ID# 169290SpokaneWashington99208-
Univ of Wisconsin Hosp/Clinics /ID# 200424MadisonWisconsin53792-0001-

Find similar trials in Chandler, AZ

By research site
Ironwood Cancer & Res Ctr· Chandler, AZHighlands Oncology Group· Fayetteville, ARCity of Hope· Duarte, CASt. Joseph Heritage Healthcare· Fullerton, CAUSC Norris Cancer Center· Los Angeles, CAHoag Memorial Hosp Presbyterian· Newport Beach, CA

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