ClinicalTrials.gov
ClinicalTrials.gov Menu

Neratinib HER Mutation Basket Study (SUMMIT) (SUMMIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01953926
Recruitment Status : Recruiting
First Posted : October 1, 2013
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

September 26, 2013
October 1, 2013
November 7, 2018
September 30, 2013
September 2021   (Final data collection date for primary outcome measure)
Objective Response Rate (ORR first) [ Time Frame: 8 weeks ]
Confirmed objective response rate 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
  • Objective Response Rate (ORR) [ Time Frame: Estimated 6 months ]
    Confirmed objective response rate (ORR) according to RECIST v1.1 or other defined response criteria with neratinib monotherapy and combination therapy.
  • Progression-free survival (PFS) [ Time Frame: Estimated 18 months ]
    Number of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
  • Clinical Benefit Rate (CBR) [ Time Frame: 16 weeks ]
    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 ]
    Time from which measurement criteria are met for overall response of CR or PR (whichever status is recorded first) until the first date of documented disease progression.
  • Overall Survival (OS) [ Time Frame: Estimated 2 years ]
    Time from Cycle 1 Day 1 to death due to any cause.
  • Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs]) [ Time Frame: From consent through 28 days following treatment completion (estimated 6 months) ]
    Safety profile and tolerability of neratinib monotherapy and combination therapy.
  • 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
 
Neratinib HER Mutation Basket Study (SUMMIT)
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 is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Malignant Solid Tumor
  • Fibrolamellar Carcinoma
  • Drug: Neratinib
    240 mg administered orally, once daily with food, continuously in 28 day cycles
    Other Name: Nerlynx
  • Drug: Paclitaxel
    80mg/m^2 administered 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, and 29; then once every 4 weeks thereafter month, then Day 1 of every 4 week cycle
  • Drug: Trastuzumab
    Initial dose of 8 mg/kg of trastuzumab administered IV on Day 1, followed by 6 mg/kg IV once every 3 weeks thereafter
  • Experimental: Neratinib monotherapy
    Neratinib monotherapy in HER2 mutated cancers excluding colon cancer, lung cancer, breast cancer and bladder cancer, HER4 mutated cancer and in lung cancer containing EGFR exon 18 mutations, and fibrolamellar carcinoma.
    Intervention: Drug: Neratinib
  • Experimental: Neratinib and Paclitaxel
    Neratinib and Paclitaxel in HER2 mutated bladder cancers.
    Interventions:
    • Drug: Neratinib
    • Drug: Paclitaxel
  • Experimental: Neratinib, Fulvestrant and Trastuzumab
    Neratinib, Fulvestrant and Trastuzumab in HER2 mutated hormone positive breast cancers.
    Interventions:
    • Drug: Neratinib
    • Drug: Fulvestrant
  • Experimental: Neratinib and Trastuzumab
    Neratinib and Trastuzumab in ERBB2 mutated Hormone negative breast, lung, and colorectal cancers.
    Interventions:
    • Drug: Neratinib
    • Drug: Trastuzumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
392
42
March 2022
September 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed cancers for which no curative therapy exists.
  • Documented HER2 mutation.
  • Pediatric patients (at least 12 but less than 18 years of age at signing of informed consent) may be recruited in the FLC cohort.

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, Older Adult)
No
Contact: Puma Biotechnology Clinical Operations Senior Director (424) 248-6500 ClinicalTrials@pumabiotechnology.com
Australia,   Belgium,   Canada,   Denmark,   Finland,   France,   Ireland,   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
Study Director: Clinical Development Senior Vice President Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
November 2018

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