Advanced Malignant Solid NeoplasmPhase 1NCT03065387

Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

A Phase 1 study testing Everolimus, Neratinib and Palbociclib in people with Advanced Malignant Solid Neoplasm and EGFR Gene Amplification, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Malignant Solid Neoplasm, EGFR Gene Amplification, EGFR Gene Mutation
What is being tested?: Everolimus, Neratinib and Palbociclib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2017to 23 Apr 2026
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

Subjects with advanced or metastatic solid tumors that are refractory to standard therapies known to provide clinical benefit. Subjects with hematologic malignancy including lymphoma/myeloma will not be enrolled on this study.
Subjects must have one of the following:
somatic mutations in human epidermal growth factor receptor (EGFR, HER2, HER3, and HER4)
EGFR gene amplification (patients with 3+ results on immunohistochemistry testing for EGFR may be allowed to enroll if gene amplification results are unavailable)
HER2 gene amplification (patients with 3+ results on immunohistochemistry testing for Her-2 may be allowed to enroll if gene amplification results are unavailable)
Somatic mutation in KRAS (Patients will be enrolled only on neratinib and trametinib combination ARM).

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Subjects must have measurable disease by RECIST v1.1. (only for MTD Expansion Cohorts)
Subjects must be ≥18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Abnormal organ function is permitted. However, subjects must have:
absolute neutrophil count ≥ 1500/mL
platelets ≥ 100,000/mL
hemoglobin ≥ 9 g/dL
creatinine ≤ 1.5 X upper limit of normal (ULN) or CrCl >40 ml/min
total bilirubin ≤ 1.5 X ULN
aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) ≤ 2.5 X ULN (≤5 X ULN in subjects with liver metastases)
Subjects must be ≥4 weeks or at least 5 half-lives beyond treatment with any chemotherapy or other investigational therapy to include hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation. Subjects must be ≥4 weeks beyond treatment with wide field radiation therapy or ≥2 weeks for limited field radiation therapy for palliation (not including whole brain radiation or stereotactic radiotherapy, for which subjects must be ≥4 weeks beyond treatment).
Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as 12 consecutive months of amenorrhea). Subjects should not become pregnant or breastfeed while on this study. Sexually active subjects must agree to use contraception for the duration of study participation and for 4 months after the last dose of neratinib and everolimus, palbociclib or trametinib.
Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
Only for subjects enrolled in Arm 1 - Neratinib and Everolimus
Fasting lipid profile: Cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL.
Subjects who are taking medications with potent inhibitors or inducers of CYP450 3A4 should be off for 5 half-lives prior to starting everolimus.
Only for subjects enrolled in Arm 2 - Neratinib and Palcociclib
Any prior neuropathy should be back to baseline or grade 1
Subjects who are taking medications with potent inhibitors or inducers of CYP450 3A4 should be off for 5 half-lives prior to starting Palbociclib.
Only for subjects enrolled in Arm 3 - Neratinib and Trametinib
All skin rash (dermatitis acneiform, erythema, xeroderma, eczema) should be at grade 1 when starting trametinib treatment.
History of retinal disorder, dry eye syndrome, or blurry vision need to be evaluated by ophthalmology prior to starting treatment.

Who cannot join

Subjects who are pregnant or breastfeeding;
Known Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.
Inability or unwillingness to swallow pills.
Active infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization.
Clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. For example, subjects should have no more than 50% of the large intestine removed and no sign of malabsorption (e.g. gastrectomy, ileal bypass, chronic diarrhea, Crohn's disease, malabsorption, gastroparesis).
Inability to comply with the study and follow-up procedures.

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History of cerebrovascular accident (CVA), myocardial infarction or unstable angina within the previous 6 months before starting therapy.
Prolongation of QT/QTc interval (QTc interval >450 ms for males or >470 ms for females) using the Fredericia method of QTc analysis. For patients with bundle branch block (BBB), the Rautaharju method of QTc analysis (QTcR) will be used.
Has active primary brain tumor, active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks with no neurological symptoms, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless or clinical stability.
Uncontrolled concurrent disease or illness including but not limited to:
symptomatic congestive heart failure (NYHA Class III or IV) per the NYHA Classification (see Appendix B), unstable angina pectoris, clinically significant cardiac arrhythmia
unstable or untreated cardiac conditions or ejection fraction of <50% as determined by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
diabetes mellitus (i.e. fasting blood glucose >220 despite acceptable chronic diabetes therapy)
psychiatric illness that would limit compliance with study requirements, as determined by the investigator
Participating in any other clinical trials using an investigational product. Only for subjects enrolled in Arm 1 - Neratinib and Everolimus
History of hypersensitivity to everolimus
Subjects requiring therapy with immunosuppressive agents such as anti-tumor necrosis factor alpha (TNFα) agents (Etanercept, Adalimumab), azathioprine, methotrexate, cyclosporine, etc for active autoimmune disorder.
Major surgery ≤28 days prior to treatment with everolimus. Only for subjects enrolled in Arm 3 - Neratinib and Trametinib
Albumin less than 3 Gm/dL

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I Study of the Pan-ERBB Inhibitor Neratinib Given in Combination With Everolimus, Palbociclib, or Trametinib in Advanced Cancer Subjects With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

This phase I trial studies the side effects and best dose of neratinib in combination with everolimus, palbociclib, or trametinib in participants with solid tumors with EGFR mutation/amplification, HER2 mutation/amplification, HER3/4 mutation, or KRAS mutation that do not respond to treatment (refractory) and have spread to other parts of the body (advanced or metastatic). Neratinib, palbociclib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving neratinib with everolimus, palbociclib, or trametinib may work better than neratinib alone in treating participants with solid tumors.

Read the detailed description

PRIMARY OBJECTIVES:

To evaluate the safety and tolerability of neratinib when combined with one of the following agents:

Ia. Arm 1: Everolimus (mTOR inhibitor) Ib. Arm 2: Palbociclib (CDK 4/6 inhibitor) Ic. Arm 3: Trametinib (MEK inhibitor). II. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of neratinib combination therapy.

SECONDARY OBJECTIVES:

To determine preliminary anti-tumor efficacy of neratinib combination therapy.

II. To determine pharmacodynamic markers in tissue, blood and plasma that may predict outcome.

III. To explore the potential of drug-drug interactions by evaluating the pharmacokinetic profile of each agent when administered in these combinations: neratinib+everolimus, neratinib+palbocclib, and neratinib+trametinib and blood-based biomarkers.

EXPLORATORY OBJECTIVES:

To determine baseline molecular markers (deoxyribonucleic acid [DNA], ribonucleic acid [RNA] and protein) that may predict clinical benefit.

II. To determine concordance of human epidermal growth factor receptor mutation (EGFR, HER2, HER3, and HER4) or EGFR, HER2 amplification in archival tissue and pre-treatment biopsies. Impact of these correlatives on response will be explored.

III. To determine concordance of human epidermal growth factor receptor mutation (EGFR, HER2, HER3, and HER4) or EGFR, HER2 amplification in tumor and cell-free DNA (cfDNA). Impact of these correlatives on response will be explored.

IV. To utilize cfDNA from plasma specimens collected during the course of treatment to explore mechanisms of primary and acquired resistance to neratinib combination therapy.

OUTLINE: This is a dose-escalation study. Participants are assigned to 1 of 3 arms.

ARM I: Participants receive neratinib orally (PO) daily and everolimus PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Participants receive neratinib PO daily and palbociclib PO daily for 3 weeks followed by 1 week off. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM III: Participants receive neratinib PO daily and trametinib PO daily as directed. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 30 days.

Conditions: Advanced Malignant Solid Neoplasm, EGFR Gene Amplification, EGFR Gene Mutation, ERBB2 Gene Amplification, ERBB2 Gene Mutation, ERBB3 Gene Mutation
Being tested: Everolimus, Neratinib, Palbociclib, Trametinib
Medical subject headings: Neoplasm Metastasis

What participants receive

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

EverolimusDrug
Also called 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001
Given PO
NeratinibDrug
Also called (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272
Given PO
PalbociclibDrug
Also called 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991
Given PO
TrametinibDrug
Also called GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Mekinist
Given PO

Study groups in NCT03065387
Study group	Role	What they receive
Arm I (neratinib, everolimus)	Experimental	Participants receive neratinib PO daily and everolimus PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Everolimus; Drug: Neratinib
Arm II (neratinib, palbociclib)	Experimental	Participants receive Neratinib PO daily for 28 days and Palbociclib PO daily for 21 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Neratinib; Drug: Palbociclib
Arm III (neratinib, trametinib)	Experimental	Participants receive neratinib PO daily and trametinib PO daily as directed. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Neratinib; Drug: Trametinib

What is being measured

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

Maximum tolerated dose (MTD) of neratinib when given in combination with everolimus, palbociclib, or trametinib
Defined by dose-limiting toxicity (DLT). The MTD will be defined as the highest dose at which no more than 1 of 6 evaluable subjects has had a DLT.
Measured: Up to 28 days

Secondary outcomes (3)

Incidence of adverse events of neratinib when given in combination with everolimus, palbociclib, or trametinib
National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to quantify the intensity of adverse events occurring during treatment in this study.
Measured: Up to 30 days post last dose
Objective response
Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The anti-tumor efficacy of each combination will be evaluated by objective response by RECIST v1.1. This analysis will not utilize statistical analysis per standard phase I trials.
Measured: Up to 5 years
Determination of pharmacodynamics markers in tissue, blood, and plasma
Pharmacodynamics markers in tissue, blood, and plasma will be determined that may predict outcome and exploration of the pharmacokinetic profile of each agent when administered in combination. Marker values will be compared between subjects with and without clinical benefit using chi-squared or Fisher exact tests for categorically-scaled markers and Wilcoxon rank sum tests for interval- and ordinal-scaled markers. Due to the large number of candidate markers, only those significant on univariate analysis will be combined into a single logistic regression model to assess their independent effects on clinical benefit. Analyses will be performed both within and across the three cohorts. Results will be considered exploratory and thus no corrections will be made for multiple testing.
Measured: Up to completion of treatment

Timeline

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

31 Oct 201723 Apr 2026

First posted27 Feb 2017
Study start31 Oct 2017
Primary completion23 Apr 2026
Study completion23 Apr 2026

Why it stopped: \<75% participation

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
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: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03065387
Sponsor's protocol ID: 2016-0430
Other IDs: NCI-2018-01218, 2016-0430
Status last verified: Jul 2026
First submitted: 22 Feb 2017
Last updated: 22 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Piha-Paul SA, Tseng C, Tran HT, Gao M, Karp DD, Subbiah V, Tsimberidou AM, Kawedia JD, Fu S, Pant S, Yap TA, Morris VK, Kee BK, Blum Murphy M, Lim J, Meric-Bernstam F. A phase I trial of the pan-ERBB inhibitor neratinib combined with the MEK inhibitor trametinib in patients with advanced cancer with EGFR mutation/amplification, HER2 mutation/amplification, HER3/4 mutation or KRAS mutation. Cancer Chemother Pharmacol. 2023 Aug;92(2):107-118. doi: 10.1007/s00280-023-04545-4. Epub 2023 Jun 14.
PubMed 37314501

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study of the Pan-ERBB Inhibitor Neratinib Given in Combination With Everolimus, Palbociclib, or Trametinib in Advanced Cancer Subjects With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation
ClinicalTrials.gov ID: NCT03065387
Acronym / sponsor ID: 2016-0430
Conditions: Advanced Malignant Solid Neoplasm, EGFR Gene Amplification, EGFR Gene Mutation, ERBB2 Gene Amplification, ERBB2 Gene Mutation, ERBB3 Gene Mutation
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: \<75% participation
Enrolment: 84 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 31 Oct 2017 (actual)
Primary completion: 23 Apr 2026 (actual)
Study completion: 23 Apr 2026 (actual)
First posted: 27 Feb 2017 (actual)
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

PRIMARY OBJECTIVES:

To evaluate the safety and tolerability of neratinib when combined with one of the following agents:

SECONDARY OBJECTIVES:

To determine preliminary anti-tumor efficacy of neratinib combination therapy.

II. To determine pharmacodynamic markers in tissue, blood and plasma that may predict outcome.

EXPLORATORY OBJECTIVES:

To determine baseline molecular markers (deoxyribonucleic acid [DNA], ribonucleic acid [RNA] and protein) that may predict clinical benefit.

IV. To utilize cfDNA from plasma specimens collected during the course of treatment to explore mechanisms of primary and acquired resistance to neratinib combination therapy.

OUTLINE: This is a dose-escalation study. Participants are assigned to 1 of 3 arms.

ARM I: Participants receive neratinib orally (PO) daily and everolimus PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM III: Participants receive neratinib PO daily and trametinib PO daily as directed. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 30 days.

Study design

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

Arm	Type	Receives
Arm I (neratinib, everolimus)	Experimental	Drug: Everolimus, Drug: NeratinibParticipants receive neratinib PO daily and everolimus PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II (neratinib, palbociclib)	Experimental	Drug: Neratinib, Drug: PalbociclibParticipants receive Neratinib PO daily for 28 days and Palbociclib PO daily for 21 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm III (neratinib, trametinib)	Experimental	Drug: Neratinib, Drug: TrametinibParticipants receive neratinib PO daily and trametinib PO daily as directed. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who may qualify

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

Key inclusion criteria (28 listed)

Subjects with advanced or metastatic solid tumors that are refractory to standard therapies known to provide clinical benefit. Subjects with hematologic malignancy including lymphoma/myeloma will not be enrolled on this study.
Subjects must have one of the following:
Subjects must have measurable disease by RECIST v1.1. (only for MTD Expansion Cohorts)
Subjects must be ≥18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Key exclusion criteria (19 listed)

Subjects who are pregnant or breastfeeding;
Known Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.
Inability or unwillingness to swallow pills.
Active infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization.
Clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. For example, subjects should have no more than 50% of the large intestine removed and no sign of malabsorption (e.g. gastrectomy, ileal bypass, chronic diarrhea, Crohn's disease, malabsorption, gastroparesis).

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
EverolimusAlso: 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001Given PO	Drug	Arm I (neratinib, everolimus)
NeratinibAlso: (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272Given PO	Drug	Arm I (neratinib, everolimus), Arm II (neratinib, palbociclib), Arm III (neratinib, trametinib)
PalbociclibAlso: 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991Given PO	Drug	Arm II (neratinib, palbociclib)
TrametinibAlso: GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, MekinistGiven PO	Drug	Arm III (neratinib, trametinib)

Primary outcome

Maximum tolerated dose (MTD) of neratinib when given in combination with everolimus, palbociclib, or trametinib
Time frame: Up to 28 days
Defined by dose-limiting toxicity (DLT). The MTD will be defined as the highest dose at which no more than 1 of 6 evaluable subjects has had a DLT.

3 secondary outcomes

Incidence of adverse events of neratinib when given in combination with everolimus, palbociclib, or trametinib
Time frame: Up to 30 days post last dose
Objective response
Time frame: Up to 5 years
Determination of pharmacodynamics markers in tissue, blood, and plasma
Time frame: Up to completion of treatment

Results and safety

The study was stopped early (reason given: \<75% participation). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Derived from this study: PubMed 37314501Piha-Paul SA, Tseng C, Tran HT, Gao M, Karp DD, Subbiah V, Tsimberidou AM, Kawedia JD, Fu S, Pant S, Yap TA, Morris VK, Kee BK, Blum Murphy M, Lim J, Meric-Bernstam F. A phase I trial of the pan-ERBB inhibitor neratinib combined with the MEK inhibitor trametinib in patients with advanced cancer with EGFR mutation/amplification, HER2 mutation/amplification, HER3/4 mutation or KRAS mutation. Cancer Chemother Pharmacol. 2023 Aug;92(2):107-118. doi: 10.1007/s00280-023-04545-4. Epub 2023 Jun 14.
MD Anderson Cancer CenterLink provided by the sponsor.

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Active, not recruitingPhase 1
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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.

Sarina A Piha-Paul principal investigator

M.D. Anderson Cancer Center

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

Questions about this trial

What is this clinical trial studying?

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 28 inclusion and 19 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: \<75% participation). Results are not available in the source record.

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?

Maximum tolerated dose (MTD) of neratinib when given in combination with everolimus, palbociclib, or trametinib (time frame: Up to 28 days). 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 NCT03065387, 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 22 Jul 2026.