HER2 Positive Metastatic Breast CancersPhase 1NCT02025192

A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

A Phase 1 study testing Tucatinib, Capecitabine and Trastuzumab in people with HER2 Positive Metastatic Breast Cancers, run by Seagen Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in patients with HER2+… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HER2 Positive Metastatic Breast Cancers
What is being tested?: Tucatinib, Capecitabine and Trastuzumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 5 sitesUnited States
Study dates: 31 Dec 2013to 16 Mar 2020
Phase: Phase 1
Are there results?: None posted in the registry

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

Metastatic breast cancer, documented as HER2+ by fluorescence in situ hybridization (FISH) and/or 3+ staining by immunohistochemistry (IHC).
Progressive disease, with a history of prior treatment with both trastuzumab and T-DM1 (unless deemed intolerant to or ineligible for T-DM1 by the investigator) for metastatic disease.
If female and of child-bearing potential, has negative pregnancy test within 14 days prior to treatment.
If a sexually active male or a sexually active female of child-bearing potential, agrees to use dual (two concurrent) forms of medically accepted contraception from the time of consent until 6 months after the last dose of ONT-380, capecitabine, or trastuzumab, whichever is longest.
Must have target or non-target lesions as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
All toxicity related to prior cancer therapies must have resolved to ≤ Grade 1, with the following exceptions: alopecia; neuropathy, which must have resolved to ≤ Grade 2; and congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely.

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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
In the opinion of the Investigator, life expectancy > 6 months.
Adequate hematologic function as defined by:
Hemoglobin ≥ 9 g/dL
Absolute neutrophil count (ANC) ≥ 1000 cells/μL
Platelets ≥ 100,000/μL
Adequate hepatic function as defined by the following:
Total bilirubin ≤ 1.5 X upper limit of normal (ULN), unless a known history of Gilbert's disease
Transaminases (aspartate aminotransferase/serum glutamic oxaloacetic transaminase [AST/SGOT] and alanine aminotransferase/serum glutamic pyruvic transaminase [ALT/SGPT]) ≤ 2.5 X ULN (< 5 X ULN if liver metastases are present)
International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN unless on medication known to alter INR and aPTT.
Creatinine clearance ≥ 50 mL/min.
Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 4 weeks prior to first dose of study drug.

Who cannot join

Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
Patient is breastfeeding.
Previous treatment with any experimental agent within 14 days or five half-lives of study treatment, whichever is greater.
Previous treatment with trastuzumab or other antibody-based therapy within three weeks of starting study treatment or with chemotherapy or hormonal cancer therapy within two weeks of starting study treatment.
Previous treatment with cumulative dose of doxorubicin > 360 mg/m2 or previous treatment with another anthracycline with cumulative dose equivalent to > 360 mg/m2 doxorubicin.
Previous treatment with:

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Capecitabine for metastatic disease at any time, for patients assigned to cohorts using capecitabine plus ONT-380 (Combination 1) or capecitabine plus trastuzumab plus ONT-380 (Combination 3). However, patients who have previous treatment with capecitabine for metastatic disease are eligible for enrollment into cohorts using trastuzumab plus ONT-380 (Combination 2). Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible to enroll into all cohorts (Combination 1, 2, or 3).
Any small molecule HER2 inhibitors including (but not limited to) lapatinib, neratinib, or afatinib within the last 4 weeks prior to initiation of study therapy.
CNS disease:
Patients with leptomeningeal disease are excluded.
Dose escalation and expansion cohorts: Patients with symptomatic CNS metastases are excluded. Patients with treated CNS metastases or untreated asymptomatic CNS metastases not requiring immediate local therapy may be eligible. Enrollment of patients with metastases must be approved by the study medical monitor.
Optional CNS disease expansion cohorts: Patients with untreated asymptomatic CNS metastases not requiring immediate local therapy or patients with progressive CNS disease following local therapy may be eligible with medical monitor approval.
History of allergic reactions to compounds of similar chemical or biological composition to capecitabine (for patients assigned to Combination 1 or 3 only), trastuzumab (for patients assigned to Combination 2 or 3 only), or ONT-380, except for a history of Grade 1 or Grade 2 Infusion Related Reaction to trastuzumab, which has been successfully managed.
Patients with uncorrectable electrolyte abnormalities.
Known to be HIV positive. HIV testing is not required for those patients who are not known to be positive.
Known carrier of Hepatitis B and / or Hepatitis C (whether active disease or not).
Known liver disease, autoimmune hepatitis, or sclerosing cholangitis.
Inability to swallow pills or any significant gastrointestinal diseases, which would preclude adequate absorption of oral medications.
Use of a strong CYP3A4 inhibitor or inducer within three elimination half-lives of the inhibitor or inducer prior to the start of study treatment.
Use of a strong CYP2C8 inducer or inhibitor within three elimination half-lives of the inducer or inhibitor prior to the start of study treatment. (See Appendix F).
Radiotherapy within 14 days of first dose of ONT-380; patient must have recovered from acute effects of radiotherapy to baseline.
Known impaired cardiac function or clinically significant cardiac disease such as ventricular arrhythmia requiring therapy, congestive heart failure, and uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
Myocardial infarction or unstable angina within 6 months prior to the first dose of study drug.
Patient with known dihydropyrimidine dehydrogenase deficiency (for patients assigned to Combination 1 or 3 only).
Patient requiring warfarin therapy with known history of difficulty in management of maintaining INR within therapeutic range. Patients on warfarin may be included if on a stable dose with a therapeutic INR.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Colorado
Aurora, Colorado, 80045
MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Providence Cancer Center
Portland, Oregon, 97213
Northwest Medical Specialties
Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: A Phase 1b, Open-label Study to Assess the Safety and Tolerability of Tucatinib (ONT-380) Combined With Capecitabine and Trastuzumab, Alone and in Combination in HER2+ Metastatic Breast Cancer

Read the detailed description

This is a study of tucatinib (ONT-380) given in combination with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.

This study will use a 3+3 dose escalation design to evaluate escalating dose levels of tucatinib (ONT-380) in each of these three combinations in order to identify the maximal tolerated dose/recommended phase 2 dose (MTD/RP2D) of tucatinib (ONT-380). The MTD/RP2D of tucatinib (ONT-380) to be used in combination with either capecitabine alone (Combination 1) or trastuzumab alone (Combination 2) will be determined prior to evaluating tucatinib (ONT-380) in combination with both capecitabine and trastuzumab (Combination 3). If Combination 1 and Combination 2 are found to be tolerable, then tucatinib (ONT-380) will be evaluated in Combination 3, using the lowest MTD/RP2D or other SMC-recommended dose of tucatinib (ONT-380) determined for either of the two drug combinations. This will be followed by enrollment of an expansion cohort of patients treated at the MTD/RP2D for Combination 3. Additional expansion cohorts for either Combination 1 (tucatinib (ONT-380) and capecitabine) or Combination 2 (tucatinib (ONT-380) and trastuzumab) may also be enrolled.

Capecitabine will be given twice per day orally at 1000 mg/m^2 on Days 1-14 of each 21-day cycle. Trastuzumab will be given as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days. However, a loading dose of trastuzumab will not be given to patients who have received trastuzumab within 4 weeks of the first study dose of trastuzumab. These patients will receive trastuzumab at 6 mg/kg each cycle, including Cycle 1. Trastuzumab may also be given on a weekly basis at 2 mg/kg IV q 7 days, but only in the circumstance that trastuzumab infusion has been delayed, and weekly infusions are required to resynchronize the cycle length to 21 days, after discussion with the medical monitor. Trastuzumab infusion rates will be per institutional guidelines. Tucatinib (ONT-380) will be given twice per day orally at a dose dependent upon the dosing cohorts to which the patient is enrolled.

There will be 3-6 evaluable patients enrolled in each cohort in the dose escalation phase, unless that dose is found to be intolerable prior to completion of enrollment. At least 6 evaluable patients are to be treated at a dose level in order for an MTD/RP2D to be determined.

Provided that only seven dose cohorts are needed for dose escalation and only the expansion cohort for Combination 3 is enrolled, up to 66 evaluable patients may be enrolled. Additional patients may be enrolled if additional expansion cohorts are opened.

Conditions: HER2 Positive Metastatic Breast Cancers
Being tested: Tucatinib, Capecitabine, Trastuzumab
Keywords: ONT-380, Capecitabine, Trastuzumab, Xeloda, Herceptin, HER2 positive breast cancer, Breast cancer, ARRY-380, Tucatinib
Medical subject headings: Breast Neoplasms

What participants receive

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

TucatinibDrug
Also called ONT-380
Administered twice per day, orally.
CapecitabineDrug
Also called Xeloda
1000mg/m^2 administered twice per day, orally in Days 1-14 of each 21-day cycle.
TrastuzumabDrug
Also called Herceptin
Administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days.

Study groups in NCT02025192
Study group	Role	What they receive
Tucatinib (ONT-380) in combination with capecitabine	Experimental	Not described Receives: Drug: Tucatinib; Drug: Capecitabine
Tucatinib (ONT-380) in combination with trastuzumab	Experimental	Not described Receives: Drug: Tucatinib; Drug: Trastuzumab
Tucatinib (ONT-380) combined with capecitabine and trastuzumab	Experimental	Not described Receives: Drug: Tucatinib; Drug: Capecitabine; Drug: Trastuzumab

What is being measured

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

Incidence of adverse events
Measured: Up to approximately 4 years
Severity of adverse events
Measured: Up to approximately 4 years

Secondary outcomes (11)

Incidence of clinical lab abnormalities (hematology, chemistry, liver function tests, coagulation, urinalysis)
Measured: Up to approximately 4 years
Severity of clinical lab abnormalities (hematology, chemistry, liver function tests, coagulation, urinalysis)
Measured: Up to approximately 4 years
Frequency of dose reductions in tucatinib (ONT-380
Measured: Up to approximately 4 years
Frequency of dose reductions in capecitabine
Measured: Up to approximately 4 years
Plasma concentrations of tucatinib (ONT-380) and metabolite
Measured: 26 months
Plasma concentrations of capecitabine and metabolites
Measured: 26 months
Objective response rate (ORR)
Objective response (OR) will be defined as a best response of complete response (CR) or partial response (PR). The ORR will be calculated as the proportion of patients in the Efficacy Evaluable Patient Set who achieve an objective response.
Measured: 26 months
Duration of response
Measured: 26 months
Disease control rate
Disease control will be defined as a best response of CR, PR, or stable disease (SD). The DCR will be calculated as the proportion of patients in the Efficacy Evaluable Patient Set who achieve disease control.
Measured: 26 months
Clinical benefit rate (CBR)
Clinical benefit will be defined as a best response of CR, PR, or SD for ≥ 6 months. The CBR will be calculated as the proportion of patients in the Efficacy Evaluable Patient Set who achieve clinical benefit.
Measured: 26 months
Progression-free survival (PFS)
PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause
Measured: Up to 6 years

Timeline

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

31 Dec 201316 Mar 2020

First posted31 Dec 2013 (estimated)
Study start31 Dec 2013
Primary completion3 Oct 2017
Study completion16 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HER2 Positive Metastatic Breast CancersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02025192
Sponsor's protocol ID: ONT-380-005
Status last verified: Jun 2020
First submitted: 17 Dec 2013
Last updated: 4 Jun 2020
Results posted: No
Data monitoring committee: Yes

Publications

Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.
PubMed 39368039
Murthy R, Borges VF, Conlin A, Chaves J, Chamberlain M, Gray T, Vo A, Hamilton E. Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study. Lancet Oncol. 2018 Jul;19(7):880-888. doi: 10.1016/S1470-2045(18)30256-0. Epub 2018 May 24.
PubMed 29804905

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b, Open-label Study to Assess the Safety and Tolerability of Tucatinib (ONT-380) Combined With Capecitabine and Trastuzumab, Alone and in Combination in HER2+ Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT02025192
Acronym / sponsor ID: ONT-380-005
Conditions: HER2 Positive Metastatic Breast Cancers
Keywords: ONT-380, Capecitabine, Trastuzumab, Xeloda, Herceptin, HER2 positive breast cancer, Breast cancer, ARRY-380
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Seagen Inc.Industry (pharma, biotech, devices)
Study start: 31 Dec 2013 (actual)
Primary completion: 3 Oct 2017 (actual)
Study completion: 16 Mar 2020 (actual)
First posted: 31 Dec 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a study of tucatinib (ONT-380) given in combination with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Tucatinib (ONT-380) in combination with capecitabine	Experimental	Drug: Tucatinib, Drug: Capecitabine
Tucatinib (ONT-380) in combination with trastuzumab	Experimental	Drug: Tucatinib, Drug: Trastuzumab
Tucatinib (ONT-380) combined with capecitabine and trastuzumab	Experimental	Drug: Tucatinib, Drug: Capecitabine, Drug: Trastuzumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Metastatic breast cancer, documented as HER2+ by fluorescence in situ hybridization (FISH) and/or 3+ staining by immunohistochemistry (IHC).
Progressive disease, with a history of prior treatment with both trastuzumab and T-DM1 (unless deemed intolerant to or ineligible for T-DM1 by the investigator) for metastatic disease.
If female and of child-bearing potential, has negative pregnancy test within 14 days prior to treatment.
If a sexually active male or a sexually active female of child-bearing potential, agrees to use dual (two concurrent) forms of medically accepted contraception from the time of consent until 6 months after the last dose of ONT-380, capecitabine, or trastuzumab, whichever is longest.
Must have target or non-target lesions as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

Key exclusion criteria (25 listed)

Medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
Patient is breastfeeding.
Previous treatment with any experimental agent within 14 days or five half-lives of study treatment, whichever is greater.
Previous treatment with trastuzumab or other antibody-based therapy within three weeks of starting study treatment or with chemotherapy or hormonal cancer therapy within two weeks of starting study treatment.
Previous treatment with cumulative dose of doxorubicin > 360 mg/m2 or previous treatment with another anthracycline with cumulative dose equivalent to > 360 mg/m2 doxorubicin.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TucatinibAlso: ONT-380Administered twice per day, orally.	Drug	Tucatinib (ONT-380) combined with capecitabine and trastuzumab, Tucatinib (ONT-380) in combination with capecitabine, Tucatinib (ONT-380) in combination with trastuzumab
CapecitabineAlso: Xeloda1000mg/m^2 administered twice per day, orally in Days 1-14 of each 21-day cycle.	Drug	Tucatinib (ONT-380) combined with capecitabine and trastuzumab, Tucatinib (ONT-380) in combination with capecitabine
TrastuzumabAlso: HerceptinAdministered at a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days.	Drug	Tucatinib (ONT-380) combined with capecitabine and trastuzumab, Tucatinib (ONT-380) in combination with trastuzumab

Primary outcome

Incidence of adverse events
Time frame: Up to approximately 4 years
Severity of adverse events
Time frame: Up to approximately 4 years

11 secondary outcomes

Incidence of clinical lab abnormalities (hematology, chemistry, liver function tests, coagulation, urinalysis)
Time frame: Up to approximately 4 years
Severity of clinical lab abnormalities (hematology, chemistry, liver function tests, coagulation, urinalysis)
Time frame: Up to approximately 4 years
Frequency of dose reductions in tucatinib (ONT-380
Time frame: Up to approximately 4 years
Frequency of dose reductions in capecitabine
Time frame: Up to approximately 4 years
Plasma concentrations of tucatinib (ONT-380) and metabolite
Time frame: 26 months
Plasma concentrations of capecitabine and metabolites
Time frame: 26 months
Objective response rate (ORR)
Time frame: 26 months
Duration of response
Time frame: 26 months
Disease control rate
Time frame: 26 months
Clinical benefit rate (CBR)
Time frame: 26 months
Progression-free survival (PFS)
Time frame: Up to 6 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Derived from this study: PubMed 39368039Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.
Derived from this study: PubMed 29804905Murthy R, Borges VF, Conlin A, Chaves J, Chamberlain M, Gray T, Vo A, Hamilton E. Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study. Lancet Oncol. 2018 Jul;19(7):880-888. doi: 10.1016/S1470-2045(18)30256-0. Epub 2018 May 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

JoAl Mayor, PharmD, BCOP study director

Seagen Inc.

Corinna Palanca-Wessels, MD, PhD study director

Seagen Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tucatinib, Capecitabine and Trastuzumab in people with HER2 Positive Metastatic Breast Cancers, run by Seagen Inc. at 5 sites in United States.

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 18 inclusion and 25 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: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of adverse events (time frame: Up to approximately 4 years). The study lists 2 primary outcomes in all. 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 NCT02025192, which also lists 2 linked publications.

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 4 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.