A phase I/II, multicenter, open-label study of EGFRmut–TKI EGF816,administered orally in adult patients with EGFRmut solid malignancies

ovartis Pharma Services AG0 sites500 target enrollmentApril 25, 2014

ConditionsSolid tumors MedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Solid tumors
Sponsor: ovartis Pharma Services AG
Enrollment: 500
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 25, 2014

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

Inclusion Criteria

•For all patients (unless otherwise specified):
•1\. Written informed consent obtained prior to any screening procedures
•2\. Patient (male or female) \= 18 years of age
•3\. Patients must have histologically or cytologically confirmed locally advanced (stage IIIB not amendable to definitive multi\-modality therapy including surgery) or metastatic (stage IV) EGFR mutant NSCLC
•4\. Patients with controlled brain metastases may participate in the trial.
•They must complete any planned radiation therapy and/or surgery \> 2 weeks prior to the first dose of study treatment and remain asymptomatic. Patients on steroids must have been on a stable low dose for 2 weeks prior to initiating study treatment.
•5\. ECOG performance status: Phase I part: 0, 1, or 2; Phase II part: 0 or 1
•6\. Presence of at least one measurable lesion according to RECIST 1\.1 per Investigator assessment. A previously irradiated site lesion may be counted as a target lesion only if there is clear sign of progression since the irradiation (see Section 14\.1 Appendix 1\)
•7\. Patients must be screened for HBV. Patients who are either HBsAq positivie or HBVDNA positive must be willing to take antiviral therapy 1\-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816\.
•8\. Patients must be screened for HCV. Patients must have negative hepatitis C antibody (HCV\-Ab) or positive HCV\-Ab but undetectable level of HCV\-RNA. Note patients with detectable HCV\-RNA are not eligible to enroll into the study.

Exclusion Criteria

•For all patients (unless otherwise specified):
•1\. Patients with a history or presence of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention)
•2\. Patients with tumors harboring an EGFR exon 20 insertion or deletion (except for Group 4 patients in the Phase II par)
•3\. Presence or History of another malignancy
•Exception: Patients who have been disease\-free for 3 years, or patients with a history of adequately treated in\-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma, non\-melanomatous cancer of skin, history of stage IA melanoma that has been cured, are eligible.
•4\. Undergone a bone marrow or solid organ transplant
•5\. Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
•6\. Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry except for control of brain metastases, topical applications, inhaled sprays, eye drops or local injections
•7\. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
•8\. Patients with out of range laboratory values defined as: