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Chemotherapy

Tucatinib + Trastuzumab + Chemotherapy for Gastrointestinal Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have an unresectable or metastatic solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below:

Cohorts 1A, 1B, 1C, and 1D: CRC, Gastric adenocarcinoma, GEJ adenocarcinoma, Esophageal adenocarcinoma, Cholangiocarcinoma, Gallbladder carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2.5 years

Awards & highlights

Study Summary

This trial will study whether tucatinib is safe when given with other anti-cancer drugs to treat gastrointestinal cancer.

Who is the study for?

This trial is for adults with HER2+ gastrointestinal cancers, including stomach and colorectal cancer, who can receive oxaliplatin-based chemotherapy. They must have a performance status that allows daily activities with minimal assistance. People cannot join if they've had severe immune-related side effects from certain cancer treatments or are known to be positive for Hepatitis B or C.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of tucatinib combined with trastuzumab and other anti-cancer drugs like pembrolizumab, FOLFOX (a regimen including fluorouracil, leucovorin, and oxaliplatin), and CAPOX (capecitabine plus oxaliplatin). It aims to see how well these combinations work against various types of gastrointestinal cancers.See study design

What are the potential side effects?

Possible side effects include allergic reactions to the medications used, potential liver issues due to hepatitis risk factors, as well as common chemotherapy-related side effects such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is inoperable or has spread, and it's one of the specified types.

Select...

My cancer is one of the following: colorectal, stomach, esophageal, bile duct, or gallbladder.

Select...

I am eligible for treatment with an oxaliplatin-based regimen, except for Cohort 1G.

Select...

I have gallbladder cancer.

Select...

I have been diagnosed with esophageal adenocarcinoma.

Select...

My cancer is in the stomach, GEJ, or esophagus.

Select...

My cancer is HER2 positive based on previous tests.

Select...

I am fully active or can carry out light work.

Select...

I am part of the CRC patient group.

Select...

I have been diagnosed with stomach cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of DLTs (Cohorts 1C, 1D, 1E, 1F, and 1G)

Incidence of adverse events (AEs) (Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B)

Incidence of dose alterations (Cohort 1D)

+2 more

Secondary outcome measures

Change in glomerular filtration rate (GFR) from baseline through 2 cycles of combination therapy (Cohorts 1A and 1B)

Confirmed objective response rate (cORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment (INV) (Cohort 2A)

Duration of response (DOR) according to RECIST v1.1 per INV (Cohorts 1C, 1E, 1F, 1G, and 2A)

+12 more

Side effects data

From 2022 Phase 2 trial • 612 Patients • NCT02614794

82%

Diarrhoea

66%

Palmar-plantar erythrodysaesthesia syndrome

60%

Nausea

48%

Fatigue

38%

Vomiting

27%

Decreased appetite

26%

Stomatitis

24%

Headache

23%

Aspartate aminotransferase increased

22%

Anaemia

22%

Alanine aminotransferase increased

20%

Blood bilirubin increased

20%

Arthralgia

18%

Hypokalaemia

17%

Constipation

17%

Cough

16%

Abdominal pain

16%

Blood creatinine increased

15%

Weight decreased

14%

Back pain

13%

Epistaxis

13%

Pain in extremity

13%

Dizziness

13%

Peripheral sensory neuropathy

13%

Dyspnoea

11%

Dry skin

11%

Dyspepsia

11%

Upper respiratory tract infection

11%

Urinary tract infection

11%

Muscle spasms

11%

Oedema peripheral

10%

Pruritus

10%

Insomnia

Hypomagnesaemia

Neutropenia

Abdominal pain upper

Dehydration

Asthenia

Myalgia

Dysgeusia

Oropharyngeal pain

Skin hyperpigmentation

Rash maculo-papular

Hypophosphataemia

Blood alkaline phosphatase increased

Thrombocytopenia

Abdominal distension

Hyperbilirubinaemia

Fall

Rhinorrhoea

Paraesthesia

Dry eye

Hyperglycaemia

Gastrooesophageal reflux disease

Influenza like illness

Pyrexia

Paronychia

Alopecia

White blood cell count decreased

Dry mouth

Neutrophil count decreased

Platelet count decreased

Muscular weakness

Hypertension

Nasopharyngitis

Seizure

Pneumonia

Influenza

Cholecystitis

Sepsis

Ejection fraction decreased

Syncope

Pleural effusion

Pulmonary embolism

Cardiac failure

Gastroenteritis

100%

80%

60%

40%

20%

Study treatment Arm

Tuc+Cap+Tra

Pbo+Cap+Tra

Trial Design

9Treatment groups

Experimental Treatment

Group I: Cohort 2BExperimental Treatment5 Interventions

Tucatinib + trastuzumab + FOLFOX given in 14-day cycles.

Group II: Cohort 2AExperimental Treatment7 Interventions

Tucatinib + trastuzumab + pembrolizumab + (FOLFOX or CAPOX). Either (1) tucatinib and FOLFOX given in 14-day cycles or (2) tucatinib and CAPOX given in 21-day cycles. Trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.

Group III: Cohort 1GExperimental Treatment3 Interventions

Tucatinib + trastuzumab + pembrolizumab. Tucatinib and trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.

Group IV: Cohort 1FExperimental Treatment5 Interventions

Tucatinib + trastuzumab + pembrolizumab + CAPOX. Tucatinib, trastuzumab, and CAPOX given in 21-day cycles and pembrolizumab given in 42-day cycles.

Group V: Cohort 1EExperimental Treatment6 Interventions

Tucatinib + trastuzumab + pembrolizumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles, trastuzumab given in 21-day cycles, and pembrolizumab given in 42-day cycles

Group VI: Cohort 1DExperimental Treatment5 Interventions

Tucatinib + trastuzumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles and trastuzumab given every 21 days

Group VII: Cohort 1CExperimental Treatment4 Interventions

Tucatinib + trastuzumab + CAPOX given in 21-day cycles

Group VIII: Cohort 1BExperimental Treatment5 Interventions

Tucatinib + trastuzumab + FOLFOX given in 14-day cycles

Group IX: Cohort 1AExperimental Treatment5 Interventions

Tucatinib + trastuzumab + FOLFOX given in 14-day cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5750

tucatinib

2018

Completed Phase 2

~800

trastuzumab

2002

Completed Phase 3

~1790

oxaliplatin

2002

Completed Phase 3

~6370

leucovorin

2005

Completed Phase 3

~1200

fluorouracil

1994

Completed Phase 3

~8440

capecitabine

2002

Completed Phase 3

~2360

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

207 Previous Clinical Trials

69,037 Total Patients Enrolled

Christopher Lux, MD, PhDStudy DirectorSeagen Inc.

JoAl Mayor, PharmD, BCOPStudy DirectorSeagen Inc.

5 Previous Clinical Trials

582 Total Patients Enrolled

Media Library

Colorectal Cancer Research Study Groups: Cohort 1F, Cohort 1G, Cohort 1E, Cohort 1A, Cohort 2A, Cohort 1B, Cohort 1C, Cohort 1D, Cohort 2B

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical institutions is this research project being conducted today?

"University of Chicago Medical Center (located in Chicago, Illinois), Washington University in St Louis (Saint Louis, Missouri), and University of New mexico Cancer Center (Albuquerque, New Mexico) are the primary locations for this clinical trial. Additionally, there are 11 other sites where this study is taking place."

Answered by AI

Are we still able to enroll patients in this research project?

"Yes, as of 11/11/2022 this trial indicated on clinicaltrials.gov is still recruiting patients for the study which started on 9/15/2020."

Answered by AI

Could you please share what other research studies have been done that included tucatinib?

"The first clinical trial for tucatinib was completed in 1999 at Ospedale di Circolo e Fondazione Macchi. As of right now, there have been a total of 1921 completed studies. At the moment, 1886 different medical trials are still ongoing; many of these within Chicago, Illinois."

Answered by AI

What are the usual indications for tucatinib?

"Generally, tucatinib is used to treat refractory fallopian tube carcinoma. However, this medication can also be effective for treating other conditions such as unresectable melanoma and microsatellite instability high."

Answered by AI

How many study participants are being recruited for this research?

"The sponsor, Seagen Inc., needs to recruit 120 individuals that fit the bill for this study. The trial will take place in multiple locations, including University of Chicago Medical Center and Washington University in St Louis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

2020. "Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04430738.

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