Clinical Trials

Puma NER-5201 (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

NCT01953926

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

Stage 4

Metastatic/Palliative

Any (provided no curative therapy available)

Neratinib

pan-HER TKI

Lee Schwartzberg, MD

Puma Biotechnologies

Phase 2

Open to Enrollment

NCT01953926

• Histologically confirmed cancer for which no curative therapy exists
• Documented HER2 (ERBB2) or HER4 (ERBB4)  mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
  • Currently CLOSED cohorts include: HER2mt lung, colorectal, and biliary
• 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

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

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

Neratinib 240mg PO daily

N/A

No