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Neratinib HER Mutation Basket Study (SUMMIT) (SUMMIT)

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ClinicalTrials.gov Identifier: NCT01953926
Recruitment Status : Recruiting
First Posted : October 1, 2013
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Fibrolamellar Carcinoma Drug: Neratinib Drug: Paclitaxel Drug: Fulvestrant Drug: Trastuzumab Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : September 30, 2013
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Neratinib

Arm Intervention/treatment
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.
Drug: Neratinib
240 mg administered orally, once daily with food, continuously in 28 day cycles
Other Name: Nerlynx

Experimental: Neratinib and Paclitaxel
Neratinib and Paclitaxel in HER2 mutated bladder cancers.
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

Experimental: Neratinib, Fulvestrant and Trastuzumab
Neratinib, Fulvestrant and Trastuzumab in HER2 mutated hormone positive breast cancers.
Drug: Neratinib
240 mg administered orally, once daily with food, continuously in 28 day cycles
Other Name: Nerlynx

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

Experimental: Neratinib and Trastuzumab
Neratinib and Trastuzumab in ERBB2 mutated Hormone negative breast, lung, and colorectal cancers.
Drug: Neratinib
240 mg administered orally, once daily with food, continuously in 28 day cycles
Other Name: Nerlynx

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. Overall Survival (OS) [ Time Frame: Estimated 2 years ]
    Time from Cycle 1 Day 1 to death due to any cause.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953926


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

  Show 35 Study Locations
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Clinical Development Senior Vice President Puma Biotechnology, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01953926     History of Changes
Other Study ID Numbers: PUMA-NER-5201
2013-002872-42 ( EudraCT Number )
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Puma Biotechnology, Inc.:
Neratinib
Nerlynx
Breast
Gastroesophageal
Endometrial
Ovarian
Biliary Tract
Solid Tumors
Cancer
HER2
HER4
EGFR
Bladder/Urinary Tract
Paclitaxel
Fulvestrant
Trastuzumab
Fibrolamellar Carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Paclitaxel
Fulvestrant
Albumin-Bound Paclitaxel
Trastuzumab
Estradiol
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones