An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Puma Biotechnology, Inc.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT01953926
First received: September 26, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Drug: Neratinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • Objective Response Rate at 8 weeks (ORR8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary objective of this study is to determine the objective response rate at 8 weeks (ORR8) following treatment with neratinib in patients with HER2 (ERBB2), HER3 (ERBB3) or EGFR mutation-positive solid tumors or with EGFR gene amplification.


Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Estimated 6 months ] [ Designated as safety issue: No ]
    Secondary Outcome Measure Description is to determine the best confirmed overall response rate (ORR) with neratinib in patients with HER2, HER3 or EGFR mutation-positive solid tumors or with EGFR gene amplification.

  • Progression-free survival (PFS) [ Time Frame: Estimated 18 months ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Clinical benefit rate (CBR) is defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) ≥16 weeks from the date of enrollment

  • Duration of Response (DOR) [ Time Frame: Estimated 1 year ] [ Designated as safety issue: No ]
    Duration of response (DOR) is defined as the time from which measurement criteria are met for CR or PR (whichever status is recorded first) until the first date of documented disease progression.

  • Overall survival (OS) [ Time Frame: Estimated 2 years ] [ Designated as safety issue: No ]
  • Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs]) [ Time Frame: From consent through 28 days following treatment completion (estimated 6 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neratinib
240mg neratinib
Drug: Neratinib
240 mg orally, once daily with food, continuously in 28 day cycles

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 240 mg by mouth with food once daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953926

Contacts
Contact: Puma Biotechnology, Clinical Operations (424) 248-6500 ClinicalTrials@pumabiotechnology.com

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Italy
Oncologia Medica-Istituti Ospitalieri di Cremona Recruiting
Cremona, Italy, 90095
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario Madrid Sanchinarro (START Madrid) Recruiting
Madrid, Spain, 28050
Sponsors and Collaborators
Puma Biotechnology, Inc.
  More Information

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01953926     History of Changes
Other Study ID Numbers: PUMA-NER-5201, 2013-002872-42
Study First Received: September 26, 2013
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Puma Biotechnology, Inc.:
Bladder/urinary tract cancer, Colorectal cancer, CRC, Endometrial cancer, Ovarian cancer,
Gastric cancer, Esophageal cancer, Solid tumors, Breast cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014