Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

Phase 2

Completed

• Conditions: Metastatic Colorectal Adenocarcinoma
• Interventions: Drug: Trastuzumab; Drug: Tucatinib

• Registration Number: NCT03043313
• Lead Sponsor: Seagen Inc.

Brief Summary

This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Study Start: 2017-06-23
• Primary Completion: 2022-03-28
• Results First Submitted: 2023-01-27
• Results First Submitted QC: 2023-03-27
• Results First Posted: 2023-04-18
• Study Completion: 2023-11-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A: Tucatinib + Trastuzumab	Trastuzumab	Non-randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
Cohort A: Tucatinib + Trastuzumab	Tucatinib	Non-randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
Cohort B: Tucatinib + Trastuzumab	Trastuzumab	Randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.
Cohort C: Tucatinib Monotherapy	Tucatinib	Randomized cohort. Participants take tucatinib twice per orally every day. Participants who do not respond to therapy may have the option to receive tucatinib and trastuzumab.
Cohort B: Tucatinib + Trastuzumab	Tucatinib	Randomized cohort. Participants take tucatinib twice per day orally on Days 1-21 and trastuzumab intravenously (into the vein; IV) on Day 1. Cycles repeat every 21 days.

Primary Outcome Measures

Name	Time	Method
Confirmed Objective Response Rate (cORR) Per RECIST v1.1 Per Blinded Independent Central Review (BICR) in Pooled Cohorts A+B	Up to 46.6 months	cORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to less than (\<)1.0 centimeter (cm). PR was defined as at least a 30 percentage (%) decrease in post-baseline sum of the diameters (sum of ...

Secondary Outcome Measures

Name	Time	Method
ORR by 12 Weeks of Treatment Per RECIST v1.1 According to BICR Assessment	Up to 3 months	ORR per BICR by 12 Weeks was defined as the percentage of participants with CR or PR by 12 weeks of treatment, and before time of crossover (Cohort C), whichever came earlier. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to more than \<1.0 cm. PR was defined as at least a 30% decrease ...
Duration of Response (DOR) Per RECIST v1.1 According to BICR Assessment	Up to 64.1 months	DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as the disappearance of all target lesions and each target lymph node must have reduction in short axis to more than \<1.0 cm. PR was defined as at least a 3...
Progression-Free Survival (PFS) Per RECIST v1.1 According to BICR Assessment for Pooled Cohorts A+B	Up to 64.1 months	PFS was defined as the time from start of study treatment (Cohort A) or date of randomization (Cohort B) to documented disease progression (as determined by BICR per RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as: at least one new malignant lesion, which also included any lymph node that was normal at baseline (\<1.0 cm sho...
Overall Survival (OS) in Pooled Cohorts A+B	Up to 71.8 months	OS was defined as the time from start of study treatment (Cohort A) or randomization (Cohort B) to date of death due to any cause.
Number of Participants With Adverse Events (AEs): Interim Analysis	Up to 49.3 months	AE: Any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs): Events that were new or worsened on or after receiving the first dose of study treatment (tucatinib or trastuzumab) and up ...
Number of Participants With AEs: Final Analysis	Up to 65.1 months	AE: Any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs): Events that were new or worsened on or after receiving the first dose of study treatment (tucatinib or trastuzumab) and up ...
Number of Participants With AEs Resulting in Dose Modification: Interim Analysis	Up to 49.3 months	Dose modification included dose reduction and dose withheld by investigator due to AEs. Dose holds were defined as any instances where planned administration of the study drug was temporarily withheld or interrupted at the direction of the treating physician. Dose reductions of trastuzumab were not allowed; if trastuzumab could not be restarted after being h...
Number of Participants With AEs Resulting in Dose Modification: Final Analysis	Up to 65.1 months	Dose modification included dose reduction and dose withheld by investigator due to AEs. Dose holds were defined as any instances where planned administration of the study drug was temporarily withheld or interrupted at the direction of the treating physician. Dose reductions of trastuzumab were not allowed; if trastuzumab could not be restarted after being h...
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Interim Analysis	Up to 49.3 months	The following hematology laboratory parameters were assessed: Hemoglobin decreased; leukocytes decreased; neutrophils decreased and Platelets decreased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study...
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology): Final Analysis	Up to 65.1 months	The following hematology laboratory parameters were assessed: Hemoglobin decreased; hemoglobin increased; leukocytes decreased; lymphocytes decreased; neutrophils decreased and Platelets decreased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose of study treatment and up...
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Interim Analysis	Up to 49.3 months	The following chemistry laboratory parameters were assessed: Potassium increased; potassium decreased; aspartate aminotransferase increased; creatinine increased; alkaline phosphatase increased; total bilirubin increased. Treatment emergent laboratory abnormalities were defined as abnormalities that were new or worsened on or after receiving the first dose o...
Number of Participants With Treatment-Emergent Laboratory Abnormalities (Chemistry): Final Analysis	Up to 65.1 months	The following chemistry laboratory parameters were assessed: Potassium increased; potassium decreased; aspartate aminotransferase increased; creatinine increased; alkaline phosphatase increased; total bilirubin increased; albumin decreased; calcium corrected for albumin decreased; calcium corrected for albumin increased; glomerular filtration rate (GFR), est...
Number of Participants With Clinically Significant Vital Signs: Final Analysis	Up to 65.1 months	Vital signs included temperature, oxygen saturation, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and weight. Vital signs were considered clinically significant: temperature: \>= 38 degree Celsius (C); oxygen saturation less than (\<)88%; SBP \>=120 millimeters of mercury (mmHg) or DBP \>=80 mmHg; SBP \>=140 mmHg or DBP \>=90 mmH...

Trial Locations

Locations (56)

Texas Oncology - Beaumont; 🇺🇸 Beaumont, Texas, United States

Lombardi Cancer Center / Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Other, Spain

Aurora Research Institute Cancer Center; 🇺🇸 Milwaukee, Wisconsin, United States

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Other, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Other, Spain

Keck Medical Center / University of Southern California; 🇺🇸 Los Angeles, California, United States

Winship Cancer Institute / Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Case Western Reserve University / University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States

Rocky Mountain Cancer Centers - Aurora; 🇺🇸 Aurora, Colorado, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

Saint Joseph Heritage Medical Group; 🇺🇸 Santa Rosa, California, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Texas Oncology - Baylor Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

Texas Oncology - McAllen; 🇺🇸 McAllen, Texas, United States

Texas Oncology - San Antonio Medical Center; 🇺🇸 San Antonio, Texas, United States

Seattle Cancer Care Alliance / University of Washington; 🇺🇸 Seattle, Washington, United States

Texas Oncology - Tyler; 🇺🇸 Tyler, Texas, United States

Providence Regional Medical Center Everett; 🇺🇸 Everett, Washington, United States

Huntsman Cancer Institute/University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Hopital Saint-Antoine; 🇫🇷 Paris, Other, France

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Florida Cancer Specialists - South Region; 🇺🇸 Fort Myers, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Niguarda Ca' Granda Hospital; 🇮🇹 Milan, Other, Italy

Northwest Cancer Specialists, P.C.; 🇺🇸 Portland, Oregon, United States

Tennessee Oncology-Nashville/Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Florida Cancer Specialists - North Region; 🇺🇸 Saint Petersburg, Florida, United States

Hôpital Franco-Britannique - Fondation Cognacq-Jay; 🇫🇷 Levallois-Perret, Other, France

Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara; 🇮🇹 Pisa, Other, Italy

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Other, Belgium

Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes; 🇫🇷 Lyon, Other, France

Instituto Europeo di Oncologia; 🇮🇹 Milan, Other, Italy

Hospitalier Jean Minjoz; 🇫🇷 Besancon, Other, France

Center Georges Francois Leclerc; 🇫🇷 Dijon, Other, France

Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute; 🇺🇸 Los Angeles, California, United States

Pacific Shores Medical Group; 🇺🇸 Long Beach, California, United States

UZ Leuven campus Gasthuisberg; 🇧🇪 Leuven, Other, Belgium

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Karmanos Cancer Institute / Wayne State University; 🇺🇸 Detroit, Michigan, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Joe Arrington Cancer Research and Treatment Center; 🇺🇸 Lubbock, Texas, United States

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Other, Belgium

Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet); 🇪🇸 L'Hospitalet de Llobregat, Other, Spain