Clinical Trial - NCT01953926

Neratinib HER Mutation Basket Study (SUMMIT)

Recruiting

Sponsor: Puma Biotechnology, Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT01953926

Protocol Info

Short Description: Phase II of Neratinib in AST with EGFR, HER2 and HER3 mutations or EGFR Gene Amplification
Long Description: 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
MGH Status: Open
Sponsor: Puma Biotechnology
Disease Program: Phase I

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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 Title Intervention Phase
Malignant Solid Tumor Fibrolamellar Carcinoma Neratinib Paclitaxel Fulvestrant Trastuzumab Phase 2
Study Type Interventional
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.

Primary Outcome Measures

Objective Response Rate (ORR first) [Time Frame: 8 weeks] [Designated as safety issue: ]


Secondary Outcome Measures

Objective Response Rate (ORR) [Time Frame: Estimated 6 months] [Designated as safety issue: ]

Progression-free survival (PFS) [Time Frame: Estimated 18 months] [Designated as safety issue: ]

Clinical Benefit Rate (CBR) [Time Frame: 16 weeks] [Designated as safety issue: ]

Duration of Response (DOR) [Time Frame: Estimated 1 year] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: Estimated 2 years] [Designated as safety issue: ]

Safety (Adverse Events and Serious Adverse Events) [Time Frame: From consent through 28 days following treatment completion (estimated 6 months)] [Designated as safety issue: ]

Estimated Enrollment: 392
Study Start Date: September 2013
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: September 2021
Arms Assigned Interventions

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

Experimental:Neratinib and Paclitaxel

Neratinib and Paclitaxel in HER2 mutated bladder cancers.
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: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: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

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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 Fibrolamellar Carcinoma cohort.

Exclusion Criteria:

  • Prior treatment with any pan-HER tyrosine kinase inhibitor (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953926

Locations

  • United States, Arizona
    • Mayo Clinic Arizona Phoenix, Arizona, United States, 85054
  • United States, California
    • City of Hope Duarte, California, United States, 91010
    • University of California, San Diego La Jolla, California, United States, 92093
    • University of Southern California Los Angeles, California, United States, 90089
    • University of California, Los Angeles Los Angeles, California, United States, 90095
    • Stanford Cancer Center Palo Alto, California, United States, 94304
    • UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California, United States, 94115
    • Kaiser Permanente NoCal (STRATA) Vallejo, California, United States, 94589
  • United States, Delaware
    • Christiana Care Health Services, Christiana Hospital Newark, Delaware, United States, 19718
  • United States, Florida
    • Mayo Clinic Florida Jacksonville, Florida, United States, 32224
    • University of Miami Miami, Florida, United States, 33136
  • United States, Georgia
    • Winship Cancer Institute, Emory University Atlanta, Georgia, United States, 30322
  • United States, Illinois
    • Northwestern University Chicago, Illinois, United States, 60611
  • United States, Louisiana
    • Ochsner Clinic Foundation New Orleans, Louisiana, United States, 70121
  • United States, Massachusetts
    • Dana Farber Cancer Institute Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • University of Michigan Ann Arbor, Michigan, United States, 48109
  • United States, Minnesota
    • Mayo Clinic Rochester, Minnesota, United States, 55905
    • Metro Minnesota Community Oncology Research Consortium Saint Louis Park, Minnesota, United States, 55416
  • United States, Missouri
    • Washington University Saint Louis, Missouri, United States, 63110
  • United States, New Jersey
    • Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey, United States, 08903
  • United States, New York
    • Roswell Park Comprehensive Cancer Center Buffalo, New York, United States, 14263
    • Memorial Sloan-Kettering Cancer Center New York, New York, United States, 10065
  • United States, Ohio
    • Kettering Medical Center Kettering, Ohio, United States, 45429
  • United States, Pennsylvania
    • UPMC Magee-Woman's Hospital, Women's Cancer Center Pittsburgh, Pennsylvania, United States, 15213
  • United States, Tennessee
    • The West Clinic Germantown, Tennessee, United States, 38138
    • Vanderbilt-Ingram Cancer Center Nashville, Tennessee, United States, 37232
  • United States, Texas
    • UT Southwestern Medical Center Dallas, Texas, United States, 75390
    • MD Anderson Cancer Center Houston, Texas, United States, 77030
  • United States, Wisconsin
    • Gundersen La Crosse, Wisconsin, United States, 54601
    • University of Wisconsin Carbone Cancer Center Madison, Wisconsin, United States, 53792
  • Australia, Victoria
    • Peter MacCallum Cancer Centre East Melbourne, Victoria, Australia, 8006
  • Belgium,
    • UZ Leuven Leuven, , Belgium, 3000
  • Canada, British Columbia
    • British Columbia Cancer Center Vancouver, British Columbia, Canada, V5Z 4E6
  • Denmark,
    • University Hospital, Rigshospitalet Kopenhagen, , Denmark, DK-2100
  • Finland,
    • Helsinki University Central Hospital Helsinki, , Finland, 00029
  • France, Ile De France
    • Institut Curie - Hopital Rene Huguenin Saint-Cloud, Ile De France, France, 92210
  • France, Paris
    • Institut Gustave Roussy Villejuif, Paris, France, 94800
  • France,
    • Centre Leon Berard Lyon, , France, 69393
  • Ireland, Leinster
    • St. Vincent's University Hospital Dublin, Leinster, Ireland, D04 T6F4
  • Israel,
    • Davidoff Cancer Center, Rabin Medical Center Petah Tikva, , Israel, 49100
    • Kaplan Medical Center Rehovot, , Israel, 76100
    • Sourasky Medical Center Tel Aviv, , Israel, 64239
  • Italy,
    • Azienda Socio Sanitaria Territoriale di Cremona Cremona, , Italy, 26100
    • AOU Citta della Salute e della Scienza di Torino Torino, , Italy, 10126
  • Korea, Republic of, Seoul
    • Yonsei University Health System, Serverance Hospital Seodaemun-Gu, Seoul, Korea, Republic of, 120-752
  • Spain,
    • Hospital Universitario Quiron Dexeus Barcelona, , Spain, 08028
    • Hospital Universitario Vall d'Hebron Barcelona, , Spain, 08035
    • Hospital Universitari Clinic Barcelona Barcelona, , Spain, 08036
    • Hospital Clinico Universitario San Carlos Madrid, , Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz Madrid, , Spain, 28040
    • Hospital Universitario Madrid Sanchinarro (START Madrid) Madrid, , Spain, 28050
    • Hospital Universitario Quiron Madrid Madrid, , Spain, 28223
    • Instituto Valenciano de Oncologia Valencia, , Spain, 46009
    • Hospital Clinico Universitario de Valencia Valencia, , Spain, 46010
  • United Kingdom,
    • University College London Hospitals NHS Foundation Trust London, , United Kingdom, NW1 2BU
    • Royal Free Hospital London, , United Kingdom, NW3 2QG

Sponsors and Collaborators

Puma Biotechnology, Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT01953926
Other Study ID Numbers: 2013-002872-42
Study First Received:
Last Updated:
Health Authority:

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

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Fulvestrant

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019