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BRIEF TITLE: Phase 2 Study Exploring the Efficacy and Safety of Neratinib Therapy in Patients With Solid Tumors With Activating HER2, HER3 or EGFR Mutations or With EGFR Gene Amplification.

An Open-label, Multicenter, Multinational, Phase 2 Study Exploring the Efficacy and Safety of Neratinib Therapy in Patients With Solid Tumors With Activating HER2, HER3 or EGFR Mutations or With EGFR Gene Amplification.


  • Org Study ID: PUMA-NER-5201
  • Secondary ID: 2013-002872-42
  • NCT ID: NCT01953926
  • NCT Alias:
  • Sponsor: Puma Biotechnology, Inc. - Industry
  • Source: Puma Biotechnology, Inc.

Brief Summary

This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.

Detailed Description


This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and
safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR
mutations or with EGFR gene amplification.

The trial will consist of a screening period, a treatment period, and an end of treatment
visit occurring when neratinib is discontinued for any reason, a safety follow-up visit
occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period
lasting for a maximum of 12 months for each patient after their last dose of neratinib or
until initiation of additional anti -cancer therapy.

Treatment will consist of neratinib alone 240 mg daily in all HER2 mutated cancers excluding
hormone positive breast cancers and bladder cancers, or neratinib 240 mg daily and paclitaxel
80 mg/m^2 IV on Days 1, 8, and 15 of every 4 week cycle in bladder cancers , or neratinib 240
mg daily and fulvestrant 500 mg on Days 1, 15 of the first month, then Day 1 of every 4 week
cycle in hormone positive breast cancers.

Overal Status Start Date Phase Study Type
Recruiting September 30, 2013 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Objective Response Rate at 8 weeks (ORR8)

Primary Outcome 1 - Time Frame: 8 weeks

Condition:

  • Solid Tumors

Eligibility

Criteria:
Inclusion Criteria:

- Histologically confirmed cancers for which no curative therapy exists.

- Documented HER2 mutation.

Exclusion Criteria:

- Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib,
neratinib).

- Patients who are receiving any other anticancer agents.

- Symptomatic or unstable brain metastases.

- Women who are pregnant or breast-feeding.

Note: There are additional inclusion and exclusion criteria. The study center will
determine if you meet all of the criteria.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Puma Biotechnology, Clinical Operations

Phone: (424) 248-6500

Email: ClinicalTrials@pumabiotechnology.com

Locations

Facility Status Contact
University of Southern California
Los Angeles, California 90089
United States
Recruiting
University of California Los Angeles
Los Angeles, California 90095
United States
Active, not recruiting
University of Miami
Miami, Florida 33136
United States
Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United States
Terminated
Washington University
Saint Louis, Missouri 63110
United States
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Withdrawn
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
Recruiting
Magee-Woman's Hospital, Women's Cancer Center
Pittsburgh, Pennsylvania 15213
United States
Recruiting
The West Clinic
Germantown, Tennessee 38138
United States
Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
United States
Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Peter MacCallum Cancer Centre
East Melbourne, Victoria 8006
Australia
Recruiting
University Hospital, Rigshospitalet
Kopenhagen, DK-2100
Denmark
Recruiting
Helsinki University Central Hospital
Helsinki, 00029
Finland
Recruiting
Rabin Medical Center
Petah Tikva, 49100
Israel
Recruiting
Kaplan Medical Center
Rehovot, 76100
Israel
Recruiting
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
Italy
Recruiting
Oncologia Medica-Istituti Ospitalieri di Cremona
Cremona, 90095
Italy
Recruiting
University and San Giovanni Battista Hospital
Torino, 10126
Italy
Active, not recruiting
Yonsei University Health System, Serverance Hospital
Seodaemun-Gu, Seoul 120-752
Korea, Republic of
Recruiting
Hospital Universitario Quiron Dexeus
Barcelona, 08028
Spain
Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Spain
Recruiting
Hospital Clinico Universitario San Carlos
Madrid, 28040
Spain
Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Spain
Recruiting
Hospital Universitario Madrid Sanchinarro (START Madrid)
Madrid, 28050
Spain
Recruiting
Hospital Universitario Quiron Madrid
Madrid, 28223
Spain
Recruiting
Instituto Valenciano de Oncologia
Valencia, 46009
Spain
Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
Recruiting
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
United Kingdom
Recruiting