AzTrials
AzTrials

NeoplasmsPhase 2NCT02091141

My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

A Phase 2 study testing Trastuzumab, Pertuzumab and Erlotinib in people with Neoplasms and Solid Tumors, run by Genentech, Inc. at 60 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Solid Tumors, Biliary Cancer
What is being tested?
Trastuzumab, Pertuzumab and Erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
673 participants
Where
60 sitesUnited States
Study dates
14 Apr 2014to 24 May 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

General Inclusion Criteria:

  • Life expectancy greater than or equal to (≥) 12 weeks
  • Histologically documented metastatic cancer (solid tumors, not including hematologic malignancies)
  • Participants who have received standard first-line therapy for metastatic cancer (except for the tumors for which no first-line therapy exists) and in whom a trial of targeted therapy is considered the best available treatment option. Eligible participants should not have available therapies that will convey clinical benefit and/or are not suitable options per the treating physician's judgment
  • No previous treatment with the specific assigned study drug or any other drug sharing the same target
  • Measurable disease by RECIST v1.1
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 (For patients enrolling in the atezolizumab arm, ECOG score must be documented within 7 days prior to first treatment and confirmation of ECOG PS must be entered into the interactive web response system [IWRS] prior to initiation of treatment)
  • Adequate hematologic, renal, and liver function as defined by the protocol
  • If applicable, use of contraception methods or abstinence as defined by the protocol

Study-Drug Specific Inclusion Criteria:

Trastuzumab plus Pertuzumab

  • Molecular testing results from clinical laboratory improvement amendments (CLIA)-certified laboratories (using tissue and/or blood) demonstrating HER2 overexpression or amplification. Participants must have one of the following tumor types: biliary cancer, salivary cancer, or bladder cancer
  1. For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
  • Left ventricular ejection fraction (LVEF) greater than (>) 50 percent (%) or above the lower limit of the institutional normal range, whichever is lower
  • Availability of an archival or new pre-treatment tissue sample is required if molecular testing was not performed by Foundation Medicine. Any available tumor tissue sample can be submitted. The tissue sample must be submitted within 4 weeks after enrollment

Erlotinib

  • Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating epidermal growth factor receptor (EGFR)-activating mutations

Vemurafenib plus Cobimetinib

  • Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating BRAF V600 mutations a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)

Vismodegib

  • Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating hedgehog pathway relevant mutation (activating mutation of smoothened [SMO] or loss-of-function mutation of protein patched homolog-1 [PTCH-1])
  1. For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
  • All non-hematological adverse events related to any prior chemotherapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade less than or equal to (≤) 2 prior to starting therapy

Alectinib

  • Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating anaplastic lymphoma kinase (ALK) gene rearrangements, ALK mutations, ALK copy number gain or (for melanoma only) increased ALK expression or presence of ALK-alternative transcription initiation transcript (ALKATI) a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)

Atezolizumab

  • Molecular testing results from CLIA-certified laboratories (using tissue) demonstrating elevated tissue tumor mutational burden (tTMB ≥10 mutations/ Megabase [Mb])
  • For patients where molecular testing was not performed using Foundation Medicine, submission of an archival or new pretreatment tissue sample is mandatory. For patients where molecular testing was performed using Foundation Medicine, submission of an archival or new pretreatment tissue sample is required, if available. The tissue sample must be submitted within 4 weeks after enrollment

General Exclusion Criteria:

  • Participants with hematologic malignancies
  • Concurrent administration of any other anti-cancer therapy (except male participants with prostate cancer receiving androgen blockade): Bisphosphonates and denosumab are allowed; Most recent anti-cancer therapy ≤28 days and have not recovered from the side effects, excluding alopecia; Radiation therapy within ≤14 days
  • Active or untreated brain metastases
  • History of carcinomatous meningitis
  • Uncontrolled concurrent malignancy (early stage is allowed if not requiring active therapy or intervention)
  • Pregnant or breastfeeding women, or intending to become pregnant during the study
  • Any significant cardiovascular events within 6 months prior to study entry
  • Pulmonary embolism within 30 days prior to study entry
  • History or presence of clinically significant ventricular or atrial dysrhythmia >Grade 2 per NCI CTCAE v4.0
  • Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Study-Drug Specific Exclusion Criteria:

Trastuzumab plus Pertuzumab

  • Previous treatment with any HER2-targeted therapy

Erlotinib

  • Non-small cell lung cancer (NSCLC) or pancreatic cancer identified by exon 19 deletions or exon 21 L858R substitution mutations
  • EGFR amplifications in the absence of EGFR-activating mutations
  • Cancers with exon 20 mutations
  • Previous treatment with erlotinib or any other EGFR inhibitor
  • Inability to swallow pills
  • Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of erlotinib

Vemurafenib plus Cobimetinib

  • Malignant melanoma, papillary thyroid cancer, colorectal cancer, or hematologic malignancy including multiple myeloma
  • LVEF below institutional lower level of normal (LLN) or below 50%, whichever is lower
  • History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration
  • Presence of any of the following conditions, which are risk factors for RVO: Uncontrolled glaucoma with intraocular pressure >21 millimetres of mercury (mm Hg); Serum cholesterol ≥Grade 2; Hypertriglyceridemia ≥Grade 2; Hyperglycemia (fasting) ≥Grade 2; Grade ≥2 uncontrolled hypertension (participants with a history of hypertension controlled with anti-hypertensive medication to Grade </=1 are eligible)
  • Prior or concurrent malignancy with known RAS mutation
  • Previous treatment with vemurafenib or any other BRAF inhibitor (prior sorafenib is allowed)
  • Previous treatment with cobimetinib or any other mitogen-activated protein/extracellular signal-regulated kinase (MEK) inhibitor
  • Prior treatment with a RAF inhibitor
  • Inability to swallow pills
  • Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of vemurafenib
  • History of congenital long QT syndrome or mean (average of triplicate measurements) corrected QT (QTc) measured using Fridericia's method ≥450 millisecond (ms) at baseline or uncorrectable abnormalities in serum electrolytes (sodium, potassium, calcium, magnesium, phosphorus)

Vismodegib

  • Basal cell carcinoma of the skin, medulloblastoma, small-cell lung cancer, or hematologic malignancies
  • Previous treatment with vismodegib or any other hedgehog pathway inhibitor
  • Inability to swallow pills
  • Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of vismodegib

Alectinib

  • ALK-positive NSCLC, neuroblastoma, and childhood tumors
  • Previous treatment with alectinib or any other ALK inhibitor
  • Participants with symptomatic bradycardia
  • Administration of strong/potent cytochrome P3A4 (CYP3A4) inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib
  • Inability to swallow pills
  • Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of alectinib

Atezolizumab

  • History of leptomeningeal disease
  • Uncontrolled tumor pain
  • Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters are allowed
  • Uncontrolled or symptomatic hypercalcemia
  • Previous treatment with atezolizumab or another programmed death-1 (PD-1)/PD-L1 inhibitor
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells
  • Known allergy or hypersensitivity to any component of the atezolizumab formulation
  • Active or history of autoimmune disease or immune deficiency
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Positive human immunodeficiency virus (HIV) test, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection or active tuberculosis
  • Severe infection within 4 weeks prior to initiation of study treatment
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study or within 5 months after the final dose of atezolizumab
  • History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
  • Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is longer) prior to randomization
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites
  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87102

  • University of New Mexico Comprehensive Cancer Center - Albuquerque Cedar Street; Drug Shipment

    Albuquerque, New Mexico, 87106

  • University of New Mexico Comprehensive Cancer Center - Albuquerque Lang NE; Drug Shipment

    Albuquerque, New Mexico, 87109

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • University Cancer & Blood Center, LLC; Research

    Athens, Georgia, 30607

  • University of Colorado

    Aurora, Colorado, 80045-2517

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

  • Univ No Carolina School of Med; Physicians Office Bldg

    Chapel Hill, North Carolina, 27599-7305v

  • Sarah Cannon Research Institute / Tennessee Oncology

    Chattanooga, Tennessee, 37404

  • Northwestern University; Robert H. Lurie Comp Can Ctr; Northwestern Medicine Development Inst

    Chicago, Illinois, 60611

  • University Of Chicago Medical Center; Section Of Hematology/Oncology

    Chicago, Illinois, 60637

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Science 37, Inc

    Culver City, California, 90230

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58102

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33916

  • The Center for Cancer and Blood Disorders - Fort Worth

    Fort Worth, Texas, 76104

  • Northeast Georgia Medical Center; Oncology Research Dept-5C

    Gainesville, Georgia, 30501

  • West Clinic

    Germantown, Tennessee, 38138

  • Western Regional Medical Center at Cancer Treatment Centers of America

    Goodyear, Arizona, 85338

  • Memorial Sloan Kettering Cancer Center at Westchester

    Harrison, New York, 10604

  • MD Anderson

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Research Medical Center - Antibiotic Research Associates, Inc.

    Kansas City, Missouri, 64132

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37920

  • Moores UCSD Cancer Center; Dept Clinical Trials Office

    La Jolla, California, 92093-0698

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Memorial Sloan Kettering - Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203

  • Vanderbilt Ingram Cancer Clinic

    Nashville, Tennessee, 37232

  • Weill Cornell Univ Medical Ctr; Breast Cancer Center

    New York, New York, 10021

  • Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Southeastern Regional Medical Center, Inc.

    Newnan, Georgia, 30265

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital Cancer Inst; Memorial System Onc Clin Rsch

    Orlando, Florida, 32804

  • Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Eastern Regional Medical Ctr

    Philadelphia, Pennsylvania, 19124

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85259

  • UPMC - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Virginia Cancer Institute

    Richmond, Virginia, 23229

  • Mayo Foundation

    Rochester, Minnesota, 55905

  • Sanford Cancer Cnt Onco Clinic

    Sioux Falls, South Dakota, 57104

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Florida Cancer Specialist, North Region

    St. Petersburg, Florida, 33705

  • Stanford Comprehensive Cancer Center

    Stanford, California, 94305

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • Florida Cancer Specialists, Research Department

    West Palm Beach, Florida, 33401

  • Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins

    Willow Grove, Pennsylvania, 19090

  • Wake Forest Univ Health Svcs; Internal Medicine

    Winston-Salem, North Carolina, 27157

  • Midwestern Regional Med Center

    Zion, Illinois, 60099

Other trials in United States

About this study

Official title: My Pathway: An Open-Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents

This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.

Being tested
Trastuzumab, Pertuzumab, Erlotinib, Vemurafenib, Cobimetinib
Medical subject headings
Neoplasms, Biliary Tract Neoplasms, Urinary Bladder Neoplasms

What participants receive

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

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.

  • PertuzumabDrug

    Also called Perjeta

    Pertuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.

  • ErlotinibDrug

    Also called Tarceva

    Erlotinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.

  • VemurafenibDrug

    Also called Zelboraf

    Vemurafenib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.

  • CobimetinibDrug

    Also called Cotellic

    Cobimetinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.

  • VismodegibDrug

    Also called Erivedge

    Vismodegib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.

  • AlectinibDrug

    Also called Alecensa

    Alectinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.

Study groups in NCT02091141
Study groupRoleWhat they receive
Trastuzumab Plus PertuzumabExperimentalParticipants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
Receives: Drug: Trastuzumab; Drug: Pertuzumab
AtezolizumabExperimentalParticipants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
Receives: Drug: Atezolizumab
VemurafenibExperimentalParticipants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
Receives: Drug: Vemurafenib
Vemurafenib Plus CobimetinibExperimentalParticipants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
Receives: Drug: Vemurafenib; Drug: Cobimetinib
VismodegibExperimentalParticipants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
Receives: Drug: Vismodegib
AlectinibExperimentalParticipants will receive alectinib 600 mg orally BID in each 28-day cycle.
Receives: Drug: Alectinib
ErlotinibExperimentalParticipants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Receives: Drug: Erlotinib

What is being measured

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

  1. Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator

    The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for all arms.

    Measured: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)

  2. Percentage of Atezolizumab-Treated Participants With Tissue Tumor Mutational Burden (tTMB) ≥16 Mutations/Mb With Overall Response, as Assessed by the Independent Review Committee (IRC)

    The Objective Response Rate (ORR) is defined as the proportion of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (68.9 months)

Secondary outcomes (5)
  1. Percentage of Participants With Disease Control

    Disease Control Rate (DCR) is defined as the proportion of patients whose best response is CR, PR or stable disease maintained more than 4 months (SD>4 months). Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.

    Measured: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from the start of study treatment to the first occurrence of disease progression, or death, whichever occurs first. Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.

    Measured: From the date of first study treatment until disease progression as assessed by the investigator, or death from any cause, whichever occurs first (72.1 months)

  3. Overall Survival (OS)

    Overall Survival (OS, months) is defined as the time from the date of the first study treatment (Day 1) to the date of death from any cause.

    Measured: 87.5 months

  4. Duration of Response (DoR)

    Duration of Response (DoR) is defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.

    Measured: From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first (70.8 months)

  5. Number of Participants With Adverse Events

    Incidence, nature, and severity of Adverse Events (AE), per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) for participants enrolled prior to Version 6 of the protocol. The NCI CTCAE (v5.0) grading scale was used for assessing AE severity for participants enrolled under Version 6 of the protocol and subsequent versions.

    Measured: From first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years)

Timeline

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

  1. First posted19 Mar 2014 (estimated)
  2. Study start14 Apr 2014
  3. Primary completion24 May 2023
  4. Study completion24 May 2023

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
673 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02091141
Sponsor's protocol ID
ML28897
Other IDs
PRO 02
Status last verified
Jun 2024
First submitted
17 Mar 2014
Last updated
23 Jul 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient-level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

Publications

  • Sweeney CJ, Hainsworth JD, Bose R, Burris HA, Kurzrock R, Swanton C, Friedman CF, Spigel DR, Szado T, Schulze K, Price R, Malato J, Lo AA, Levy J, Wang Y, Yu W, Meric-Bernstam F. MyPathway Human Epidermal Growth Factor Receptor 2 Basket Study: Pertuzumab + Trastuzumab Treatment of a Tissue-Agnostic Cohort of Patients With Human Epidermal Growth Factor Receptor 2-Altered Advanced Solid Tumors. J Clin Oncol. 2024 Jan 20;42(3):258-265. doi: 10.1200/JCO.22.02636. Epub 2023 Oct 4.

    PubMed 37793085
  • Narita Y, Yoshimoto T, Namai T, Asakawa T, Kawakami S, Gower-Page C, Reyes-Rivera I, Patel A, Nakamura Y. Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm. JCO Clin Cancer Inform. 2022 May;6:e2200022. doi: 10.1200/CCI.22.00022.

    PubMed 35649212
  • Friedman CF, Hainsworth JD, Kurzrock R, Spigel DR, Burris HA, Sweeney CJ, Meric-Bernstam F, Wang Y, Levy J, Grindheim J, Shames DS, Schulze K, Patel A, Swanton C. Atezolizumab Treatment of Tumors with High Tumor Mutational Burden from MyPathway, a Multicenter, Open-Label, Phase IIa Multiple Basket Study. Cancer Discov. 2022 Mar 1;12(3):654-669. doi: 10.1158/2159-8290.CD-21-0450.

    PubMed 34876409
  • Javle M, Borad MJ, Azad NS, Kurzrock R, Abou-Alfa GK, George B, Hainsworth J, Meric-Bernstam F, Swanton C, Sweeney CJ, Friedman CF, Bose R, Spigel DR, Wang Y, Levy J, Schulze K, Cuchelkar V, Patel A, Burris H. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021 Sep;22(9):1290-1300. doi: 10.1016/S1470-2045(21)00336-3. Epub 2021 Jul 30.

    PubMed 34339623
  • Meric-Bernstam F, Hurwitz H, Raghav KPS, McWilliams RR, Fakih M, VanderWalde A, Swanton C, Kurzrock R, Burris H, Sweeney C, Bose R, Spigel DR, Beattie MS, Blotner S, Stone A, Schulze K, Cuchelkar V, Hainsworth J. Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2019 Apr;20(4):518-530. doi: 10.1016/S1470-2045(18)30904-5. Epub 2019 Mar 8.

    PubMed 30857956
  • Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted Therapy for Advanced Solid Tumors on the Basis of Molecular Profiles: Results From MyPathway, an Open-Label, Phase IIa Multiple Basket Study. J Clin Oncol. 2018 Feb 20;36(6):536-542. doi: 10.1200/JCO.2017.75.3780. Epub 2018 Jan 10.

    PubMed 29320312

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab, Pertuzumab and Erlotinib in people with Neoplasms and Solid Tumors, run by Genentech, Inc. at 60 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?

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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator (time frame: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)). 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 NCT02091141, which also lists 6 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 23 Jul 2024.

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