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Small Molecule Kinase Inhibitor
Neratinib for Solid Tumors (SUMMIT Trial)
Phase 2
Waitlist Available
Research Sponsored by Puma Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months
Awards & highlights
SUMMIT Trial Summary
This trial is studying neratinib to treat patients with solid tumors that have a HER mutation.
Eligible Conditions
- Solid Tumors
SUMMIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort)
Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts)
Secondary outcome measures
Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts)
Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts)
+6 moreSide effects data
From 2022 Phase 2 trial • 11 Patients • NCT03094052100%
Diarrhea
100%
Constipation
82%
Nausea
45%
Fatigue
45%
Abdominal distension
36%
Headache
36%
Dizziness
27%
Hot flashes
27%
Pruritus
27%
Dyspnea
27%
Weight loss
27%
Vomiting
27%
Anorexia
18%
Dysgeusia
18%
Alanine aminotransferase increased
18%
Aspartate aminotransferase increased
18%
Fever
18%
Gastrointestinal disorders - Other, specify
18%
Abdominal pain
18%
Bloating
18%
Sinus bradycardia
18%
Skin and subcutaneous tissue disorders - Other, specify
9%
Anxiety
9%
Cholecystitis
9%
Mucositis oral
9%
Paresthesia
9%
Rash maculo-papular
9%
Upper respiratory infection
9%
Fracture
9%
Back pain
9%
Joint range of motion decreased
9%
Vaginal dryness
9%
Lymphedema
9%
Anal hemorrhage
9%
Muscle weakness upper limb
9%
Musculoskeletal and connective tissue disorder - Other, specify
9%
Vaginal hemorrhage
9%
Chills
9%
Vaginal discharge
9%
Gastroesophageal reflux disease
9%
Creatinine increased
9%
Bruising
9%
Vaginal infection
9%
Arthralgia
9%
Pain
9%
Urinary tract pain
9%
Wheezing
9%
Ejection fraction decreased
9%
Peripheral sensory neuropathy
9%
Insomnia
9%
Flatulence
9%
Flu like symptoms
9%
Rash acneiform
9%
Oral dysesthesia
9%
Stomach pain
9%
General disorders and administration site conditions - Other, specify
9%
Infections and infestations - Other, specify
9%
Fall
9%
Neck pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Neratinib)
SUMMIT Trial Design
6Treatment groups
Experimental Treatment
Group I: Neratinib, Fulvestrant and Trastuzumab (Randomized)Experimental Treatment3 Interventions
Neratinib, Fulvestrant and Trastuzumab or Fulvestrant and Trastuzumab or Fulvestrant alone in HER2 mutated (HR-positive with prior CDK4/6i) breast cancers.
Group II: Neratinib, Fulvestrant and Trastuzumab (Non-Randomized)Experimental Treatment3 Interventions
Neratinib, Fulvestrant and Trastuzumab in HER2 mutated (HR-positive with or without CDK4/6i) breast cancers.
Group III: Neratinib monotherapyExperimental Treatment1 Intervention
Neratinib monotherapy in HER2 mutated cancers including cervical, salivary gland, and lung cancers containing EGFR exon 18 mutations.
Cohorts closed to enrollment in prior amendments: HER2 mutant cancers including bladder/urinary, colorectal, endometrial, breast HR-positive, TNBC HR-negative, lung, gastroesophageal, biliary, and ovarian; HER3 mutant solid tumor NOS; HER4 mutant solid tumor NOS; fibrolamellar carcinoma and EGFR brain.
Group IV: Neratinib and TrastuzumabExperimental Treatment2 Interventions
Neratinib and Trastuzumab in HER2 mutated (TNBC, HR-negative) breast cancers.
Cohorts closed to enrollment in in prior amendments: colorectal, lung cancer HER2 mutant.
Group V: Neratinib and PaclitaxelExperimental Treatment2 Interventions
Neratinib and Paclitaxel in HER2 mutated bladder/urinary tract cancers.
Group VI: Neratinib and FulvestrantExperimental Treatment2 Interventions
Neratinib and Fulvestrant in HER2 mutated (HR-positive) breast cancers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Neratinib
2014
Completed Phase 2
~1970
Fulvestrant
2011
Completed Phase 3
~3690
Trastuzumab
2014
Completed Phase 4
~5190
Find a Location
Who is running the clinical trial?
Puma Biotechnology, Inc.Lead Sponsor
56 Previous Clinical Trials
9,210 Total Patients Enrolled
Senior Vice President Clinical Science and PharmacologyStudy DirectorPuma Biotechnology, Inc.
5 Previous Clinical Trials
5,613 Total Patients Enrolled
Chief Scientific OfficerStudy DirectorPuma Biotechnology, Inc.
7 Previous Clinical Trials
880 Total Patients Enrolled
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