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Trial record 1 of 1 for:    NCT01610336
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A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment

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: NCT01610336
Recruitment Status : Active, not recruiting
First Posted : June 4, 2012
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will assess the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that are known to have dysregulation of the c-MET pathway and who have failed after benefiting on a prior treatment with either gefitinib or erlotinib.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: INC280 Phase 2

Detailed Description:
Patients will be treated INC280 and gefitinib(250mg) daily. Dose escalation for INC280 will be performed. Each cohort for the phase IB part will consist of 3 to 6 newly enrolled patients. A twice daily administration of INC280 may be investigated if deemed appropriate based on emerging results from ongoing clinical trials.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment
Actual Study Start Date : April 5, 2012
Estimated Primary Completion Date : May 27, 2020
Estimated Study Completion Date : May 27, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: INC280+gefitinib
INC280+gefitinib
Drug: INC280
experimental




Primary Outcome Measures :
  1. Phase Ib: Frequency and characteristics of dose limiting toxicities (DLTs) to the [ Time Frame: From date of treatment until DLT, up to 52weeks ]
    1 cycle= 28 days

  2. Phase II : Overall Response Rate of tumors per RECIST 1.1 [ Time Frame: from date of treatment until disease progression, up to 100 weeks ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From date of treatment until death, up to 5 years ]
    OS is defined as the time from the date of treatment to the date of death from any cause.

  2. Frequency, duration, and severity of adverse events (AEs) [ Time Frame: 30 days post study treatment ]
    Safety via monitoring of AEs

  3. Inhibition of c-MET signaling by pre- and post- treatment immunohistochemistry of p-c-MET, [ Time Frame: Day 15 of cycle 1 ]
    1 cycle= 28 days

  4. Plasma concentration of INC280 [ Time Frame: Day 1 of cycle 4 ]
    1 cycle= 28 days

  5. Progression free survival (PFS) [ Time Frame: From date of treatment to the date of disease progression, up to 5 years ]
    PFS is defined as the time from the date of treatment to the date of event defined as the first documented progression per RECIST or death due to any cause.

  6. Plasma concentration of gefitinib [ Time Frame: Day 1 and 15 cycle 2, Day 1 of cycle 3 and 4 ]
    1 cycle= 28 days

  7. PK parameters AUC [ Time Frame: Day 1 and 15 cycle 2, Day 1 of cycle 3 and 4 ]
    1 cycle= 28 days

  8. PK parameters Cmax [ Time Frame: Day 1 and 15 cycle 2, Day 1 of cycle 3 and 4 ]
    1 cycle= 28 days

  9. PK parameters Tmax [ Time Frame: Day 1 and 15 cycle 2, Day 1 of cycle 3 and 4 ]
    1 cycle= 28 days

  10. PK parameters accumulation ration [ Time Frame: Day 1 and 15 cycle 2, Day 1 of cycle 3 and 4 ]
    1 cycle= 28 days

  11. PK parameters half- life [ Time Frame: Day 1 and 15 cycle 2, Day 1 of cycle 3 and 4 ]
    1 cycle= 28 days

  12. number of SAE, and severity of serious adverse events (SAEs) [ Time Frame: 30 days post study treatment ]
    Safety via monitoring SAEs

  13. number of AE [ Time Frame: 30 days post study treatment ]
    via monitoring changes in physical examination, clinical laboratory parameters, vital signs and ECGs



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.


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

Inclusion Criteria:

  • Documented EGFR mutation
  • Documented c-MET dysregulation
  • Prior clinical benefit on EGFR inhibitors and then subsequent progression

    -≥ 18 year old

  • Life expectancy of ≥ 3 months
  • ECOG performance status ≤ 2

Exclusion Criteria:

  • Unable to swallow tables once or twice daily
  • Previous treatment with c-MET inhibitor
  • Any unresolved toxicity form previous anticancer therapy greater than grade 1
  • History of cystic fibrosis
  • History of acute or chronic pancreatitis
  • Unable to undergo MRI or CT sans
  • Known history of HIV
  • Undergone a bone marrow or solid organ transplant
  • Clinically significant wound or lung tumor lesions with increased likelihood of bleeding
  • Pregnant or nursing

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): NCT01610336


Locations
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Australia, Queensland
Novartis Investigative Site
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Novartis Investigative Site
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Novartis Investigative Site
East Bentleigh, Victoria, Australia, 3165
Australia
Novartis Investigative Site
Auckland, Australia
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
China, Guangdong
Novartis Investigative Site
Guangzhou, Guangdong, China, 51000
China, Shanghai
Novartis Investigative Site
Shanghai, Shanghai, China, 200433
China
Novartis Investigative Site
Beijing, China, 100039
Novartis Investigative Site
Guangzhou, China, 510060
France
Novartis Investigative Site
Strasbourg Cedex, France, 67091
Novartis Investigative Site
Toulouse Cedex 9, France, 31059
Germany
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Freiburg, Germany, 79106
Israel
Novartis Investigative Site
Haifa, Israel, 3525408
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Italy
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Milano, MI, Italy, 20133
Novartis Investigative Site
Milano, MI, Italy, 20141
Novartis Investigative Site
Modena, MO, Italy, 41124
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 464 8681
Novartis Investigative Site
Koto ku, Tokyo, Japan, 135 8550
Korea, Republic of
Novartis Investigative Site
Gyeonggi do, Korea, Korea, Republic of, 10408
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 05505
Novartis Investigative Site
Seoul, Seocho Gu, Korea, Republic of, 06591
Novartis Investigative Site
Seoul, Korea, Republic of, 03080
Novartis Investigative Site
Seoul, Korea, Republic of, 06351
Netherlands
Novartis Investigative Site
Maastricht, AZ, Netherlands, 5800
Novartis Investigative Site
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site
Rotterdam, Netherlands, 3015 GD
Singapore
Novartis Investigative Site
Singapore, Singapore, 169610
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Madrid, Spain, 28034
Taiwan
Novartis Investigative Site
Tainan, Taiwan, 70403
Novartis Investigative Site
Taipei, Taiwan, 10002
Thailand
Novartis Investigative Site
Bangkok, THA, Thailand, 10330
Novartis Investigative Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01610336    
Other Study ID Numbers: CINC280X2202
2011-002569-39 ( EudraCT Number )
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
EGFR
c-MET
Lung cancer
Gefitinib
Erlotinib
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms