A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies

A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies

ClinicalTrials.gov Identifier: NCT02108964

Novartis Reference Number: CEGF816X2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

To estimate the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) (Phase l part) of EGF816 and to investigate the anti-tumor activity of EGF816 (Phase II part).

Condition 
Advanced Non-small Cell Lung Cancer
Phase 
Phase 1
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
226 participants
Start date 
Jun 06, 2014
Completion date 
Dec 31, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
EGF816
EGF816 will be dosed once daily. On the first day of each treatment Cycle, the patient receives an adequate drug supply for self-administration at home. The investigator must emphasize compliance with the study treatment and will instruct the patient to take EGF816 exactly as prescribed.

Eligibility Criteria

Inclusion Criteria: (For all patients unless otherwise specified)

Histologically or cytologically confirmed locally advanced (stage IIIB not amenable to definitive multi-modality therapy including surgery) or metastatic (stage IV) EGFR mutant NSCLC.
Patients with controlled brain metastases
ECOG performance status: Phase I part: 0, 1, or 2; Phase II part: 0 or 1
Presence of at least one measurable lesion according to RECIST 1.1
Patients who are either HBsAg positive or HBV-DNA positive must be willing and able 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
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 for the study.
For Phase I: patients must have failed no more than 3 lines of any systemic antineoplastic therapy for advanced NSCLC, including EGFR-TKI
For Phase II: patients must be naïve from any systemic antineoplastic therapy in the advanced setting. Patients who have failed no more than 1 cycle of systemic antineoplastic therapy in the advanced setting are allowed.

Exclusion criteria: (Applies to all patients unless otherwise specified)

Patients with a history or presence of ILD or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention)
Presence or history of another malignancy
Undergone a bone marrow or solid organ transplant
Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
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
Patients with clinically significant, uncontrolled heart disease
Any prior therapies ≤ 4 weeks prior to the first dose of study treatment
Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 and cannot be discontinued 1 week prior to the start of EGF816 treatment and for the duration of the study.
Patients who have impairment of GI function or GI disease that may significantly alter the absorption of EGF816 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
Patients who are receiving treatment with any enzyme-inducing anticonvulsant that cannot be discontinued at least 1 week before first dose of study treatment, and for the duration of the study
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping treatment Other protocol-defined inclusion and exclusion criteria may apply.

Study Locations

United States
Massachusetts General Hospital Mass General
-
Boston, 02114
Massachusetts
United States
Memorial Sloan Kettering Oncology Department
-
New York, 10017
New York
United States
Canada
Novartis Investigative Site
-
Toronto, M5G 2M9
Ontario
Canada
Germany
Novartis Investigative Site
-
Koeln, 50937
Nordrhein-Westfalen
Germany
Novartis Investigative Site
-
Berlin, 13125
-
Germany
Japan
Novartis Investigative Site
-
Nagoya, 464 8681
Aichi
Japan
Novartis Investigative Site
-
Fukuoka-city, 811-1395
Fukuoka
Japan
Korea, Republic of
Novartis Investigative Site
-
Seoul, 05505
Korea
Korea, Republic of
Novartis Investigative Site
-
Seoul, 03080
-
Korea, Republic of
Netherlands
Novartis Investigative Site
-
Amsterdam, 1066
-
Netherlands
Singapore
Novartis Investigative Site
-
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
-
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
-
Madrid, 28041
-
Spain
Taiwan
Novartis Investigative Site
-
Taipei, 10041
Taiwan ROC
Taiwan

Have a question?

Call 1-999-669-6682 or email [email protected]