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.
Verified February 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: February 19, 2014
Last verified: February 2014

September 26, 2013
February 19, 2014
September 2013
July 2015   (final data collection date for primary outcome measure)
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.
Objective Response Rate at 8 weeks (ORR8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01953926 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall Response Rate (ORR) [ Time Frame: Estimated 6 months ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
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
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.

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
Drug: Neratinib
240 mg orally, once daily with food, continuously in 28 day cycles
Experimental: Neratinib
240mg neratinib
Intervention: Drug: Neratinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2015
July 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Puma Biotechnology, Clinical Operations (424) 248-6500 ClinicalTrials@pumabiotechnology.com
United States
 
NCT01953926
PUMA-NER-5201, 2013-002872-42
No
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Not Provided
Puma Biotechnology, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP