Neratinib HER Mutation Basket Study (SUMMIT)

a study on Solid Tumor Fibrolamellar Carcinoma

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Michelle Melisko

Description

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.

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.

Details

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.

Keywords

Malignant Solid Tumor Fibrolamellar Carcinoma Neratinib Nerlynx Breast Gastroesophageal Endometrial Ovarian Biliary Tract Solid Tumors Cancer HER2 HER4 EGFR Bladder/Urinary Tract Paclitaxel Fulvestrant Trastuzumab Carcinoma, Hepatocellular Albumin-Bound Paclitaxel Neratinib monotherapy Neratinib and Paclitaxel Neratinib, Fulvestrant and Trastuzumab Neratinib and Trastuzumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • Stanford Cancer Center accepting new patients
    Palo Alto California 94304 United States
  • Kaiser Permanente NoCal (STRATA) accepting new patients
    Vallejo California 94589 United States

Lead Scientist

  • Michelle Melisko
    Dr. Michelle E. Melisko is a cancer specialist with expertise in breast cancer treatment and research. She is interested in testing new chemotherapy combinations, biological therapies and immunotherapies for breast cancer, with a particular focus on treatment of cancer that has spread to the brain.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Puma Biotechnology, Inc.
Links
Neratinib is effective in breast tumors bearing both amplification and mutation of ERBB2 (HER2)
ID
NCT01953926
Phase
Phase 2
Study Type
Interventional
Last Updated