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LDK378 in Patients With ALK Positive NSCLC Previously Treated With Alectinib.

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Small-Cell Lung Cancer

Intervention: LDK378 (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Makoto Nishio, Medical doctor, Principal Investigator, Affiliation: Cancer institute Hospital

Overall contact:
Novartis Pharmaceuticals, Phone: +81337978748

Summary

This is a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd will continue until the patient experiences disease progression as determined by the investigator according to RECIST 1. 1, unacceptable toxicity that precludes further treatment, pregnancy, start of a new anticancer therapy, discontinues treatment at the discretion of the patient or investigator, lost to follow-up, death, or study is terminated by Sponsor.

Clinical Details

Official title: A Phase II, Multi-center, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of Oral LDK378 Treatment for Patients With ALK-Positive Non-Small Cell Lung Cancer Previously Treated With Alectinib

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall response rate (ORR) to LDK378 by investigator assessment

Secondary outcome:

Disease control rate (DCR)

Tumor response (TTR)

Duration of response (DOR)

Progression free survival (PFS)

Overall survival (OS)

Overall intracranial response rate (OIRR)

Safety profile of LDK378 by analyzing adverse events (AEs), electrocardiagrams (ECGs) and laboratory abnormalities

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that

carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test.

- Patients must have NSCLC that has progressed at study enrollment.

- Patients must have received previous treatment with alectinib for treatment of

locally advanced or metastatic NSCLC

- Patients must be chemotherapy-naïve or have received only one line of prior cytotoxic

chemotherapy.

- Age 18 years or older at the time of informed consent.

Exclusion Criteria:

- Patients with known hypersensitivity to any of the excipients of LDK378.

- Patients with prior treatment with crizotinib, or any other ALK inhibitor

investigational agents other than alectinib.

- Prior systemic anti-cancer (including investigational) therapy aside from alectinib

and one regimen of previous cytotoxic chemotherapy for locally advanced or metastatic NSCLC.

- Patients with symptomatic central nervous system (CNS) metastases who are

neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.

- Patient with history of interstitial lung disease or interstitial pneumonitis,

including clinically significant radiation pneumonitis.

- Ptients with history of carcinomatous meningitis.

- Patient with a concurrent malignancy or history of a malignant disease other than

NSCLC that has been diagnosed and/or required therapy within the past 3 years.

- Patient has clinically significant, uncontrolled heart disease and/or recent cardiac

event (within 6 months) Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Pharmaceuticals, Phone: +81337978748

Novartis Investigative Site, Fukuoka 811-1395, Japan; Recruiting

Novartis Investigative Site, Nagoya, Aichi 464-8681, Japan; Recruiting

Novartis Investigative Site, Kashiwa, Chiba 277-8577, Japan; Not yet recruiting

Novartis Investigative Site, Akashi, Hyogo 673-8558, Japan; Recruiting

Novartis Investigative Site, Kyoto-city, Kyoto 606-8507, Japan; Recruiting

Novartis Investigative Site, Natori, Miyagi 981-1293, Japan; Recruiting

Novartis Investigative Site, Okayama-city, Okayama 700-8558, Japan; Recruiting

Novartis Investigative Site, OsakaSayama, Osaka 589-8511, Japan; Not yet recruiting

Novartis Investigative Site, Chuo-ku, Tokyo 104-0045, Japan; Not yet recruiting

Novartis Investigative Site, Koto, Tokyo 135-8550, Japan; Recruiting

Additional Information

Starting date: August 2015
Last updated: August 19, 2015

Page last updated: August 23, 2015

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