West Cancer Center

MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB4mt: SUMMIT

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

Title

Puma NER-5201 (SUMMIT)

Study Title

Site Link

NCT01953926

Malignancy

Bladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Any (provided no curative therapy available)

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

Lee Schwartzberg, MD

Sponsor

Puma Biotechnologies

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

NCT01953926

Key Eligibility Criteria Details

One of the following malignancies:
- Cervical cancer
- HR+/HER2- Breast cancer with prior CDK4/6 inhibitor
- HR+/HER2 - Breast cancer without prior CDK4/6 inhibitor
- TNBC
- Salivary Gland tumor
- NSCLC with EGFR exon-18 mutation
Documented HER2 (ERBB2) mutation (or EGFR exon 18 mutation in NSCLC).
At least one measurable or evaluable lesion
LVEF >/=50%
ECOG PS 0-2
No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
No symptomatic or unstable brain mets (stable are allowed)
No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
No uncontrolled cardiac disease
No chronic diarrheal disorder

Objective

Primary- ORR at 8 weeks: Secondary- ORR, PFS, DoR, OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer

Dosing Frequency

Neratinib 240mg PO daily

Control Agents

N/A

Study Protocol

Randomized