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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


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