PUMA : 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.

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Bowel (colorectum), Breast, Female reproductive organs, Head and neck, Lung, Sarcoma, Skin, Stomach and upper gastrointestinal tract, Urinary systemAnus,Astrocytoma,Basal cell carcinoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cervix,Chondrosarcoma,Colon,Colorectum,Melanoma (Skin),Cutaneous Squamous Cell Carcinoma (CSCC),Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastro-oesophageal junction,Germ cell and sex cord stromal cell,Glioblastoma (GBM),Glioma,Kidney,Leiomyosarcoma,Liposarcoma,Liver,Medullablastoma,Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Cutaneous Squamous Cell Carcinoma (CSCC),Stomach,Synovial Sarcoma,Testis,Throat (hypopharynx),Thyroid,Urothelial,Urothelial,Uterus,Melanoma (Ocular),Vagina,Voice box (larynx),Vulva,Gastro-oesophageal junction ,Urinary tract

Trial Overview Read MoreRead more

This phase II trial is evaluating neratinib (targeted) therapy in patients that have solid cancers with activating HER2, HER3 or EGFR mutations.
 

This trial is treating patients with advanced cancers that express HER2, HER3 or EGFR mutations.

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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.

Commercial Sponsor

Puma Biotechnology, Inc.

Summary

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. Treatment will consist of neratinib 240 mg by mouth with food once daily.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140