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Combination Therapy for Gastroesophageal Cancer (MOUNTAINEER-02 Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

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

Must have

Phase 2 paclitaxel dose optimization stage: HER2 amplification in a blood-based NGS assay performed at a central laboratory, or HER2 overexpression/amplification immunohistochemistry (IHC) and in situ hybridization (ISH) (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample

History of prior treatment with a HER2-directed antibody

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

MOUNTAINEER-02 Trial Summary

This trial is being done to see if a combination of drugs works better than another drug to treat HER2+ cancer and to look at side effects.

Who is the study for?

This trial is for adults with advanced HER2+ gastric or gastroesophageal junction adenocarcinoma that has worsened after first-line therapy. Participants must have a life expectancy of at least 3 months and be in good physical condition (ECOG score of 0 or 1). They should not have had more than one prior systemic treatment, no recent taxanes, gastrectomy, or certain other cancer drugs.Check my eligibility

What is being tested?

The study compares the effectiveness of tucatinib combined with trastuzumab, ramucirumab, and paclitaxel versus just ramucirumab and paclitaxel in treating HER2+ stomach cancers. It's conducted in phases: Phase 2 is open-label while Phase 3 is blinded so participants don't know which treatment they receive.See study design

What are the potential side effects?

Possible side effects include reactions to drug infusions, gastrointestinal issues like nausea and diarrhea, blood cell count changes leading to increased infection risk or bleeding problems, fatigue, liver function changes, and potential heart issues due to trastuzumab.

MOUNTAINEER-02 Trial Eligibility Criteria

Inclusion Criteria

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

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My cancer shows HER2 amplification or overexpression based on specific blood or tissue tests.

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I have been treated with a HER2-targeting drug before.

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I am fully active or have some restrictions but can still care for myself.

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My cancer is advanced HER2+ gastric or gastroesophageal and cannot be removed by surgery.

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My cancer has been HER2 positive since my last treatment.

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My cancer has worsened after initial treatment for advanced stomach or esophagus cancer.

MOUNTAINEER-02 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during first cycle of treatment; up to one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during first cycle of treatment; up to one month

This trial's timeline: 3 weeks for screening, Varies for treatment, and during first cycle of treatment; up to one month 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 adverse events (AEs) (Phase 2 only)

Incidence of dose modifications (Phase 2 only)

Incidence of dose-limiting toxicities (DLTs) (Phase 2 only)

+3 more

Secondary outcome measures

AUC to AUClast of paclitaxel (Phase 2 only)

Area under the plasma concentration-time curve (AUC) to the time of the last quantifiable concentration (AUClast) of tucatinib (Phase 2 only)

Change from baseline in health-related quality of life (HRQoL)

+23 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

Hypophosphataemia

Blood alkaline phosphatase increased

Rash maculo-papular

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

MOUNTAINEER-02 Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2 ArmExperimental Treatment4 Interventions

Tucatinib + trastuzumab + ramucirumab + paclitaxel

Group II: Arm 3CExperimental Treatment4 Interventions

Tucatinib + ramucirumab + paclitaxel + trastuzumab placebo

Group III: Arm 3AExperimental Treatment4 Interventions

Tucatinib + trastuzumab + ramucirumab + paclitaxel

Group IV: Arm 3BActive Control4 Interventions

Ramucirumab + paclitaxel + tucatinib placebo + trastuzumab placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ramucirumab

2009

Completed Phase 3

~650

trastuzumab

2002

Completed Phase 3

~1790

paclitaxel

1996

Completed Phase 3

~4310

tucatinib

2018

Completed Phase 2

~800

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

207 Previous Clinical Trials

69,140 Total Patients Enrolled

Michelle Ubowski, PharmDStudy DirectorSeagen Inc.

1 Previous Clinical Trials

120 Total Patients Enrolled

JoAl Mayor, PharmD, BCOPStudy DirectorSeagen Inc.

5 Previous Clinical Trials

685 Total Patients Enrolled

Media Library

Paclitaxel (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04499924 — Phase 2 & 3

Gastroesophageal Junction Adenocarcinoma Research Study Groups: Phase 2 Arm, Arm 3A, Arm 3B, Arm 3C

Gastroesophageal Junction Adenocarcinoma Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT04499924 — Phase 2 & 3

Paclitaxel (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04499924 — Phase 2 & 3

Frequently Asked Questions

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

What are the standard benefits of tucatinib?

"tucatinib is most commonly administered as a treatment for cyclophosphamide. It has also been used to treat conditions such as metastatic bladder cancer, locally advanced non-small cell lung cancer, and received one or more prior anti-her2-based regimens in the metastatic setting."

Answered by AI

Are there other published papers on tucatinib's effects?

"City of Hope Comprehensive Cancer Center first researched tucatinib in 1997 and, as of now, 1454 trials have been completed. Out of these 1058 studies are still recruiting patients, many located in Phoenix, Arizona."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer

2021. "Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04499924.

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