ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02276027
Recruitment Status : Active, not recruiting
First Posted : October 27, 2014
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
To investigate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162

Condition or disease Intervention/treatment Phase
Adenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma Drug: BYL719 Drug: INC280 Drug: LDK378 Drug: MEK162 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open Label, Multiple Arm Study of Single Agent AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : January 20, 2015
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Ceritinib

Arm Intervention/treatment
Experimental: BYL719
20 NSCLC patients. Patient's tumor must have molecular alteration of the PIK3CA gene.
Drug: BYL719
BYL719 will be dosed as 350 mg once daily. On the first day of each cycle, patient will receive a prescription of adequate drug supply for self-administration at home. The investigator must emphasize compliance and will instruct the patient to take BYL719 exactly as prescribed.

Experimental: INC280
20 NSCLC patients. Patient's tumor must have molecular alteration of the c-MET gene.
Drug: INC280
INC280 will be dosed as 600 mg (tablet) or 400mg(Capsule) twice daily. On the first day of each cycle, patient will receive a prescription of adequate drug supply for self-administration at home. The investigator must emphasize compliance and will instruct the patient to takeINC280 exactly as prescribed.

Experimental: LDK378
25 NSCLC patients.Patient's tumor must have ALK or ROS1 gene rearrangement.
Drug: LDK378
LDK378 will be dosed as 750 mg once daily. On the first day of each cycle, patient will receive a prescription of adequate drug supply for self-administration at home. The investigator must emphasize compliance and will instruct the patient to take LDK378 exactly as prescribed.

Experimental: MEK162
20 NSCLC patients. Patient's tumor must have KRAS, NRAS or BRAF mutation.
Drug: MEK162
MEK162 will be dosed as 45 mg twice daily. On the first day of each cycle, patient will receive a prescription of adequate drug supply for self-administration at home. The investigator must emphasize compliance and will instruct the patient to take MEK162 exactly as prescribed.




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: from the date of treatment until disease progression, up to 1 year ]
    ORR (Overall response rate ) of non-small cell lung cancer (NSCLC) patients. Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria


Secondary Outcome Measures :
  1. Overall survival of NSCLC patients [ Time Frame: from the date of treatment until death, up to 2 year ]
    Overall survival (OS) of non-small cell lung cancer (NSCLC) patients. OS is defined as the time from date of randomization/start of treatment to date of death due to any cause.

  2. Progression-free survival of NSCLC patients [ Time Frame: from the date of treatment until disease progression, up to 1 year ]
    Progression-free survival (PFS) of non-small cell lung cancer (NSCLC) patients. PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause according to RECIST 1.1 criteria

  3. Disease control rate of NSCLC patients [ Time Frame: from the date of treatment until disease progression, up to 1 year ]
    Disease control rate (DCR) of non-small cell lung cancer (NSCLC) patients treated with first or second line therapies. DCR is the proportion of patients with a best overall response of CR or PR or SD according to RECIST 1.1 criteria

  4. Duration of overall response of NSCLC patients [ Time Frame: from the date of treatment until disease progression, up to 1 year ]
    Duration of overall response (CR or PR) of non-small cell lung cancer (NSCLC) patients. For patients with a CR or PR (which may have to be confirmed the start date is the date of first documented response (CR or PR) and the end date and censoring is defined the same as that for time to progression according to RECIST 1.1 criteria

  5. Frequency/severity of adverse events (AEs) [ Time Frame: 30 days post treatment ]
    As a measure of safety and tolerability.

  6. Pharmacokinetics profile of BYL719 [ Time Frame: Day 1, Day 2, Day 15 and Day 16 of cycle 1; Day 1 of Cycle 2 and Cycle3, 1 cycle is 28 days ]
    Pharmacokinetics parameters including but not limited to area under the curve (AUC0-t), Maximum plasma concentration after a single dose (Cmax), Peak plasma concentration (Tmax), Median terminal elimination half-life (T1/2), The median accumulation ratio (Racc), Clearance (CL/F) and volume of distribution.

  7. Pharmacokinetics profile of INC280 [ Time Frame: Day 15 and Day 16 of cycle 1; Day 1 of Cycle 2 and Cycle3, 1 cycle is 28 days ]
    Pharmacokinetics parameters including but not limited to area under the curve (AUC0-t), Maximum plasma concentration after a single dose (Cmax), Peak plasma concentration (Tmax), Median terminal elimination half-life (T1/2), The median accumulation ratio (Racc), Clearance (CL/F) and volume of distribution.

  8. Pharmacokinetics profile of LDK378 [ Time Frame: Day 15 and Day 16 of cycle 1; Day 1 of Cycle 2 and Cycle3, 1 cycle is 28 days ]
    Pharmacokinetics parameters including but not limited to area under the curve (AUC0-t), Maximum plasma concentration after a single dose (Cmax), Peak plasma concentration (Tmax), Median terminal elimination half-life (T1/2), The median accumulation ratio (Racc), Clearance (CL/F) and volume of distribution.

  9. Pharmacokinetics profile of MEK162 [ Time Frame: Day 15 and Day 16 of cycle 1; Day 1 of Cycle 2 and Cycle3, 1 cycle is 28 days ]
    Pharmacokinetics parameters including but not limited to area under the curve (AUC0-t), Maximum plasma concentration after a single dose (Cmax), Peak plasma concentration (Tmax), Median terminal elimination half-life (T1/2), The median accumulation ratio (Racc), Clearance (CL/F) and volume of distribution.

  10. Frequency/severity of serious adverse events (SAEs) [ Time Frame: 30 days post treatment ]
    As a measure of safety and tolerability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced (stage IIIB or stage IV) NSCLC
  • Must have specific molecular alterations

Exclusion Criteria:

  • Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to control their CNS disease
  • Radiation therapy within ≤ 4 weeks prior to study entry, with the exception of limited field palliative radiotherapy for bone pain relief.
  • Any other malignancies within the last 5 years before study entry
  • Major surgery ≤ 2 weeks prior to study entry or who have not recovered from side effects of such therapy

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276027


Locations
China, Guangdong
Novartis Investigative Site
Guangzhou, Guangdong, China, 51000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02276027     History of Changes
Other Study ID Numbers: CINC280X2205
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
adenocarcinoma lung cancer,squamous cell lung carcinoma, NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ceritinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action