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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01953926




Registration number
NCT01953926
Ethics application status
Date submitted
26/09/2013
Date registered
1/10/2013

Titles & IDs
Public title
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Scientific title
An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
Secondary ID [1] 0 0
2013-002872-42
Secondary ID [2] 0 0
PUMA-NER-5201
Universal Trial Number (UTN)
Trial acronym
SUMMIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Neratinib
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Paclitaxel

Experimental: Neratinib monotherapy - Neratinib monotherapy in HER2 mutated cancers including cervical, salivary gland, and lung cancers containing EGFR exon 18 mutations.

Cohorts closed to enrollment in prior amendments: HER2 mutant cancers including bladder/urinary, colorectal, endometrial, breast HR-positive, TNBC HR-negative, lung, gastroesophageal, biliary, and ovarian; HER3 mutant solid tumor NOS; HER4 mutant solid tumor NOS; fibrolamellar carcinoma and EGFR brain.

Experimental: Neratinib and Trastuzumab - Neratinib and Trastuzumab in HER2 mutated (TNBC, HR-negative) breast cancers.

Cohorts closed to enrollment in in prior amendments: colorectal, lung cancer HER2 mutant.

Experimental: Neratinib, Fulvestrant and Trastuzumab (Randomized) - Neratinib, Fulvestrant and Trastuzumab or Fulvestrant and Trastuzumab or Fulvestrant alone in HER2 mutated (HR-positive with prior CDK4/6i) breast cancers.

Experimental: Neratinib, Fulvestrant and Trastuzumab (Non-Randomized) - Neratinib, Fulvestrant and Trastuzumab in HER2 mutated (HR-positive with or without CDK4/6i) breast cancers.

Experimental: Neratinib and Paclitaxel - Neratinib and Paclitaxel in HER2 mutated bladder/urinary tract cancers.

Experimental: Neratinib and Fulvestrant - Neratinib and Fulvestrant in HER2 mutated (HR-positive) breast cancers.


Treatment: Drugs: Neratinib
240 mg administered orally, once daily with food, continuously in 28 day cycles

Treatment: Drugs: Fulvestrant
500 mg administered as two 5 mL injections on Days 1, 15, and 29; then once every 4 weeks thereafter month, then Day 1 of every 4 week cycle

Treatment: Drugs: Trastuzumab
Initial dose of 8 mg/kg of trastuzumab administered IV on Day 1, followed by 6 mg/kg IV once every 3 weeks thereafter

Treatment: Drugs: Paclitaxel
80mg/m\^2 administered IV on Days 1, 8, and 15 of every 4 week cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Timepoint [1] 0 0
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Primary outcome [2] 0 0
Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort)
Timepoint [2] 0 0
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Primary outcome [3] 0 0
Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts)
Timepoint [3] 0 0
From first treatment date to first Complete or Partial Response, whichever came earlier, assessed up to 8 or 9 weeks
Secondary outcome [1] 0 0
Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort)
Timepoint [1] 0 0
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Secondary outcome [2] 0 0
Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts)
Timepoint [2] 0 0
From first treatment date to confirmed Complete or Partial Response, assessed up to 58 months.
Secondary outcome [3] 0 0
Duration of Response (DOR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Timepoint [3] 0 0
From first response to first disease progression or death, assessed up to 58 months
Secondary outcome [4] 0 0
Duration of Response (DOR) by Investigator Review (All Cohorts)
Timepoint [4] 0 0
From first response to first disease progression or death, assessed up to 58 months
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Timepoint [5] 0 0
From enrollment date to first documented response or stable disease =16, or =24 weeks for breast cancer, assessed up to 58 months
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts)
Timepoint [6] 0 0
From enrollment date to first documented response or stable disease =16, or =24 weeks for breast cancer, assessed up to 58 months
Secondary outcome [7] 0 0
Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Timepoint [7] 0 0
From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
Secondary outcome [8] 0 0
Progression-Free Survival (PFS) by Investigator Review (All Cohorts)
Timepoint [8] 0 0
From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 months
Secondary outcome [9] 0 0
Number of Participants With Treatment-Emergent Adverse Events
Timepoint [9] 0 0
From first dose through 28 days after the last dose, assessed up to 75 months.

Eligibility
Key inclusion criteria
* Provide written informed consent
* Histologically confirmed cancers for which no curative therapy exists
* Documented HER2 or EGFR exon 18 mutation
* Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol
* At least one measurable lesion, defined by RECIST v1.1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants harboring ineligible somatic HER2 mutations
* Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible
* Participants who are receiving any other anticancer agents
* Symptomatic or unstable brain metastases
* Women who are pregnant or breast-feeding

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/01/2023
Sample size
Target
Accrual to date
Final
582
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
8006 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Denmark
State/province [21] 0 0
Kopenhagen
Country [22] 0 0
France
State/province [22] 0 0
Ile De France
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Bordeaux
Country [25] 0 0
France
State/province [25] 0 0
Lyon
Country [26] 0 0
Ireland
State/province [26] 0 0
Leinster
Country [27] 0 0
Israel
State/province [27] 0 0
Jerusalem
Country [28] 0 0
Israel
State/province [28] 0 0
Petah Tikva
Country [29] 0 0
Israel
State/province [29] 0 0
Ramat Gan
Country [30] 0 0
Israel
State/province [30] 0 0
Rehovot
Country [31] 0 0
Israel
State/province [31] 0 0
Tel Aviv
Country [32] 0 0
Italy
State/province [32] 0 0
Cremona
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Italy
State/province [34] 0 0
Roma
Country [35] 0 0
Italy
State/province [35] 0 0
Torino
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Serbia
State/province [37] 0 0
Belgrade
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Puma Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chief Scientific Officer
Address 0 0
Puma Biotechnology, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
Available to whom?
Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.

Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://pumabiotechnology.com/data_sharing_policy.html


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01953926