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 2016 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 19, 2016
Last verified: July 2016
  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: 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: 292
Study Start Date: September 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2017 (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   (Adult, Senior)
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

  Show 29 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
  More Information

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 19, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Puma Biotechnology, Inc.:
Neratinib
Fulvestrant, Paclitaxel, HER2
Breast, Bladder/Urinary Tract, Biliary Tract, Endometral Ovarian Cancer
Gastroesophageal, Solid tumors

ClinicalTrials.gov processed this record on July 21, 2016