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AzTrials

CancerPhase 2NCT03368859

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

A Phase 2 study testing Leucovorin, Fluorouracil - bolus and Bevacizumab in people with Cancer, run by AbbVie at 65 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Leucovorin, Fluorouracil - bolus and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
65 sitesin 6 countries
Study dates
20 Mar 2018to 18 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
  • Primary tumor has been resected > 3 months prior to randomization.
  • At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
  • Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting.
  • Adequate hematologic, renal and hepatic function.

Who cannot join

  • Any prior therapy with irinotecan
  • Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2
  • Clinically significant conditions that increase the risk for antiangiogenic therapy.
  • History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.

Trial locations and contacts

65 sites in 6 countries.

65 sites in 6 countries

United States46 sites

  • Kaiser Permanente, Waterpark III Institute for Health Research /ID# 200801

    Aurora, Colorado, 80014

  • Ironwood Cancer & Res Ctr /ID# 200044

    Chandler, Arizona, 85224-5665

  • Fairview Hospital - Moll Pavilion /ID# 205910

    Cleveland, Ohio, 44111-5605

  • Cleveland Clinic Main Campus /ID# 200325

    Cleveland, Ohio, 44195

  • IACT Health /ID# 169292

    Columbus, Georgia, 31904-8946

  • Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 210112

    Dallas, Texas, 75235-7709

  • UTSW-Dallas /ID# 204031

    Dallas, Texas, 75390

  • City of Hope /ID# 200501

    Duarte, California, 91010

  • Whiteside Institute for Clinic /ID# 200802

    Duluth, Minnesota, 55805

  • Duke University Medical Center /ID# 169657

    Durham, North Carolina, 27710-3000

  • Virginia Cancer Specialists /ID# 169293

    Fairfax, Virginia, 22031

  • Highlands Oncology Group /ID# 169289

    Fayetteville, Arkansas, 72703-4005

  • Florida Cancer Specialist - South /ID# 203796

    Fort Myers, Florida, 33901-8108

  • Fort Wayne Medical Oncology /ID# 201616

    Fort Wayne, Indiana, 46804

  • St. Joseph Heritage Healthcare /ID# 200100

    Fullerton, California, 92835

  • Greenville Hospital System /ID# 203021

    Greenville, South Carolina, 29605

  • Ingalls Memorial Hosp /ID# 169892

    Harvey, Illinois, 60426

  • Millennium Oncology /ID# 204925

    Houston, Texas, 77090-1243

  • Kadlec Clinic Hematology and O /ID# 170811

    Kennewick, Washington, 99336

  • USC Norris Cancer Center /ID# 200410

    Los Angeles, California, 90033

  • Norton Cancer Institute /ID# 200674

    Louisville, Kentucky, 40207

  • Univ of Wisconsin Hosp/Clinics /ID# 200424

    Madison, Wisconsin, 53792-0001

  • Hillcrest Hospital /ID# 205911

    Mayfield Heights, Ohio, 44124

  • Tennessee Oncology-Nashville Centennial /ID# 203424

    Nashville, Tennessee, 37203-1632

  • Tennessee Oncology, PLLC /ID# 203581

    Nashville, Tennessee, 37203

  • Ochsner Clinic Foundation-New Orleans /ID# 169291

    New Orleans, Louisiana, 70121

  • Hoag Memorial Hosp Presbyterian /ID# 202661

    Newport Beach, California, 92663

  • INTEGRIS Cancer Institute of OK/INTEGRIS Southwest Medical Center /ID# 200831

    Oklahoma City, Oklahoma, 73109-3411

  • INTEGRIS Cancer Institute /ID# 200832

    Oklahoma City, Oklahoma, 73142

  • University of Nebraska /ID# 203195

    Omaha, Nebraska, 68198

  • The Valley Hospital /ID# 169999

    Paramus, New Jersey, 07652

  • Illinois Cancer Care, PC /ID# 202189

    Peoria, Illinois, 61615

  • Thomas Jefferson University /ID# 200833

    Philadelphia, Pennsylvania, 19107-4414

  • UPMC Hillman Cancer Ctr /ID# 200672

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University /ID# 170807

    Portland, Oregon, 97239

  • Torrance Health Association (DBA)Torrance Memorial Physician Network/Cancer Care /ID# 202488

    Redondo Beach, California, 90277-3036

  • UC Davis Comprehensive Cancer Center - Main /ID# 207227

    Sacramento, California, 95817

  • Mmcorc /Id# 202099

    Saint Louis Park, Minnesota, 55416

  • Pacific Central Coast Health Centers-SLO Oncology and Hematology Health Center /ID# 201215

    San Luis Obispo, California, 93401-7068

  • Central Coast Medical Oncology /ID# 200227

    Santa Maria, California, 93454-5909

  • University of California, Los /ID# 169294

    Santa Monica, California, 90404

  • Medical Oncology Associates /ID# 169290

    Spokane, Washington, 99208

  • Washington University School /ID# 200621

    St Louis, Missouri, 63108

  • Florida Cancer Specialists-Panhandle /ID# 203787

    Tallahassee, Florida, 32308-5304

  • Georgetown University Hospital /ID# 202903

    Washington D.C., District of Columbia, 20007

  • Cancer Center of Kansas /ID# 200627

    Wichita, Kansas, 67214

Other trials in United States

Belgium5 sites

  • Imelda Ziekenhuis /ID# 200693

    Bonheiden, 2820

  • Cliniques universitaires Saint /ID# 203101

    Brussels, 1200

  • UZ Antwerp /ID# 200694

    Edegem, 2650

  • UZ Gent /ID# 200691

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven /ID# 200001

    Leuven, 3000

Other trials in Belgium

Spain5 sites

  • Hospital Universitario Vall d'Hebron /ID# 200186

    Barcelona, 08035

  • Hospital General Universitario Gregorio Maranon /ID# 200189

    Madrid, 28007

  • Hospital Clinico Universitario San Carlos /ID# 201721

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 200187

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro /ID# 200190

    Madrid, 28050

Other trials in Spain

South Korea4 sites

  • National Cancer Center /ID# 170879

    Goyang, Gyeonggido, 10408

  • Samsung Medical Center /ID# 170875

    Seoul, Seoul Teugbyeolsi, 06351

  • Seoul National University Hospital /ID# 170878

    Seoul, 03080

  • Asan Medical Center /ID# 170877

    Seoul, 05505

Other trials in South Korea

Taiwan3 sites

  • Taichung Veterans General Hosp /ID# 170123

    Taichung, 40705

  • Taipei Veterans General Hosp /ID# 170675

    Taipei, 11217

  • National Taiwan Univ Hosp /ID# 170677

    Taipei City, Taipei, 10002

Other trials in Taiwan

Canada2 sites

  • Hospital Maisonneuve-Rosemont /ID# 171590

    Montreal, Quebec, H1T 2M4

  • Jewish General Hospital /ID# 171584

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab

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.

Conditions
Cancer
Being tested
Leucovorin, Fluorouracil - bolus, Bevacizumab, Fluorouracil - infusion, ABT-165
Keywords
cancer, colorectal cancer, ABT-165, FOLFIRI, Bevacizumab, bowel cancer, metastatic colorectal cancer, metastatic colorectal
Medical subject headings
Neoplasms, Colorectal Neoplasms, Intestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LeucovorinDrug

    Also called Folinic Acid

    Intravenous

  • Fluorouracil - bolusDrug

    Also called 5-FU

    Intravenous

  • BevacizumabDrug

    Also called Avastin

    Intravenous

  • Fluorouracil - infusionDrug

    Also called 5-FU

    Intravenous

  • ABT-165Drug

    Intravenous

  • IrinotecanDrug

    Also called Irinotecan hydrochloride

    Intravenous

Study groups in NCT03368859
Study groupRoleWhat they receive
ABT-165 plus FOLFIRIExperimentalABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Receives: Drug: Leucovorin; Drug: Fluorouracil - bolus; Drug: Fluorouracil - infusion; Drug: ABT-165; Drug: Irinotecan
Bevacizumab plus FOLFIRIActive comparatorBevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
Receives: Drug: Leucovorin; Drug: Fluorouracil - bolus; Drug: Bevacizumab; Drug: Fluorouracil - infusion; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is defined as the time from randomization until the first occurrence of radiographic progression determined by investigator assessment or death from any cause.

    Measured: 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

Secondary outcomes (2)

  1. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by a investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.

    Measured: From randomization up to 30 days after last dose of study drug; median time on follow-up was 25.6 (0.3 - 64.4) and 37.6 (0.3 - 66.3) weeks in ABT-165 plus FOLFIRI and Bevacizumab plus FOLFIRI, respectively

  2. Overall Survival (OS)

    OS is defined as the time from randomization until death from any cause.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2017
  2. Study start20 Mar 2018
  3. Primary completion18 Dec 2019
  4. Study completion18 Dec 2019

Why it stopped: Study may continue

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03368859
Sponsor's protocol ID
M14-064
Other IDs
2017-003669-87, 2017
Status last verified
Jan 2021
First submitted
6 Dec 2017
Last updated
9 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Strickler JH, Cubillo A, Liang JT, Matrana M, Kozloff M, Lowe T, Blaney M, Sahtout M, Naumovski L, Wainberg ZA. Efficacy and safety of dilpacimab (ABT-165) versus bevacizumab plus FOLFIRI in metastatic colorectal cancer: a phase II study. Future Oncol. 2022 Sep;18(27):3011-3020. doi: 10.2217/fon-2021-1603. Epub 2022 Aug 3.

    PubMed 35920133

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Leucovorin, Fluorouracil - bolus and Bevacizumab in people with Cancer, run by AbbVie at 65 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Belgium, Spain, South Korea, Taiwan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03368859, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.

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