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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 August 2017 by Puma Biotechnology, Inc.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT01953926
First received: September 26, 2013
Last updated: August 9, 2017
Last verified: August 2017
September 26, 2013
August 9, 2017
September 30, 2013
September 2017   (Final data collection date for primary outcome measure)
Objective Response Rate at 8 weeks (ORR8) [ Time Frame: 8 weeks ]
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 ]
Complete list of historical versions of study NCT01953926 on ClinicalTrials.gov Archive Site
  • Overall Response Rate (ORR) [ Time Frame: Estimated 6 months ]
    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 ]
  • Clinical Benefit Rate (CBR) [ Time Frame: 16 weeks ]
    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 ]
    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 ]
  • Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs]) [ Time Frame: From consent through 28 days following treatment completion (estimated 6 months) ]
  • Overall Response Rate (ORR) [ Time Frame: Estimated 6 months ]
  • Progression-free survival (PFS) [ Time Frame: Estimated 18 months ]
  • Clinical Benefit Rate (CBR) [ Time Frame: 16 weeks ]
    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 ]
    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 ]
  • Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs]) [ Time Frame: From consent through 28 days following treatment completion (estimated 6 months) ]
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 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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumors
  • Drug: Neratinib
    Neratinib 240 mg orally, once daily with food, continuously in 28 day cycles
    Other Name: Nerlynx
  • Drug: Paclitaxel
    80mg/m^2 IV on Days 1, 8, and 15 of every 4 week cycle
  • Drug: Fulvestrant
    500 mg administered as two 5 mL injections on Days 1, 15 of the first month, then Day 1 of every 4 week cycle
  • Experimental: Neratinib monotherapy
    Neratinib monotherapy in any HER2 mutated Cancers excluding Hormone positive breast cancers and bladder cancers
    Intervention: Drug: Neratinib
  • Experimental: Neratinib and Paclitaxel
    Neratinib and Paclitaxel in HER2 mutated bladder cancers
    Interventions:
    • Drug: Neratinib
    • Drug: Paclitaxel
  • Experimental: Neratinib and Fulvestrant
    Neratinib and Fulvestrant in HER2 mutated hormone positive breast cancers Interventions
    Interventions:
    • Drug: Neratinib
    • Drug: Fulvestrant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
292
December 2018
September 2017   (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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Puma Biotechnology, Clinical Operations (424) 248-6500 ClinicalTrials@pumabiotechnology.com
Australia,   Belgium,   Denmark,   Finland,   Israel,   Italy,   Korea, Republic of,   Spain,   United Kingdom,   United States
 
 
NCT01953926
PUMA-NER-5201
2013-002872-42 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Not Provided
Puma Biotechnology, Inc.
August 2017

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