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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01610336




Registration number
NCT01610336
Ethics application status
Date submitted
3/04/2012
Date registered
4/06/2012

Titles & IDs
Public title
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
Scientific 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
Secondary ID [1] 0 0
2011-002569-39
Secondary ID [2] 0 0
CINC280X2202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INC280
Treatment: Drugs - Gefitinib

Experimental: INC280 100 mg Cap QD Phase Ib - cap=capsule; QD=once daily

Experimental: INC280 200 mg Cap QD Phase Ib - cap=capsule; QD=once daily

Experimental: INC280 400 mg Cap QD Phase Ib - cap=capsule; QD=once daily

Experimental: INC280 800 mg Cap QD Phase Ib - cap=capsule; QD=once daily

Experimental: INC280 200 mg Cap BID Phase Ib - cap=capsule; BID=twice daily

Experimental: INC280 400 mg Cap BID Phase Ib - cap=capsule; BID=twice daily

Experimental: INC280 600 mg Cap BID Phase Ib - cap=capsule; BID=twice daily

Experimental: INC280 200 mg Tab BID Phase Ib - tab=tablet; BID=twice daily

Experimental: INC280 400 mg Tab BID Phase Ib - tab=tablet; BID=twice daily

Experimental: INC280 400 mg Cap BID Phase II - cap=capsule; BID=twice daily

Experimental: INC280 400 mg Tab BID Phase II - tab=tablet; BID=twice daily


Treatment: Drugs: INC280
During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.

Treatment: Drugs: Gefitinib
Gefitinib 250 mg taken once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase Ib: Frequency of Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Up to 215 weeks
Primary outcome [2] 0 0
Phase II : Overall Response Rate (ORR)
Timepoint [2] 0 0
Until disease progression, up to 60.8 weeks
Secondary outcome [1] 0 0
Phase Ib and II: Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Up to 421 weeks
Secondary outcome [2] 0 0
Phase Ib and II: Number of Participants With Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 421 weeks
Secondary outcome [3] 0 0
Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level
Timepoint [3] 0 0
Up to 417 weeks
Secondary outcome [4] 0 0
Phase Ib and II: Number of Patients With Dose Interruptions of Gefitinib by Dose Level
Timepoint [4] 0 0
Up to 417 weeks
Secondary outcome [5] 0 0
Phase II: Overall Survival (OS)
Timepoint [5] 0 0
From date of treatment until death due to any cause, up to 70.2 months
Secondary outcome [6] 0 0
Phase II: Progression Free Survival (PFS)
Timepoint [6] 0 0
Up to 60.8 months
Secondary outcome [7] 0 0
Phase II: Duration of Response (DoR)
Timepoint [7] 0 0
Up to 23.2 months
Secondary outcome [8] 0 0
Phase I: PK Parameters AUCtau of INC280 and Gefitinib
Timepoint [8] 0 0
Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Secondary outcome [9] 0 0
Phase I: PK Parameters Cmax of INC280 and Gefitinib
Timepoint [9] 0 0
Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Secondary outcome [10] 0 0
Phase I: PK Parameters Tmax of INC280 and Gefitinib
Timepoint [10] 0 0
Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Secondary outcome [11] 0 0
Phase I: PK Parameters Apparent Systemic Plasma Clearance Rate of INC280 and Gefitinib
Timepoint [11] 0 0
Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose) (Cycle=28 days)
Secondary outcome [12] 0 0
Phase I: PK Parameters Half-life of INC280 and Gefitinib
Timepoint [12] 0 0
Cycle 1 day 15 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose)(Cycle=28 days)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to swallow tables once or twice daily
* Previous treatment with c-MET inhibitor
* Any unresolved toxicity from previous anticancer therapy greater than grade 1
* History of cystic fibrosis
* History of acute or chronic pancreatitis
* Unable to undergo MRI or CT scans
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/05/2020
Sample size
Target
Accrual to date
Final
161
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [2] 0 0
Novartis Investigative Site - East Bentleigh
Recruitment hospital [3] 0 0
Novartis Investigative Site - Auckland
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [3] 0 0
- Auckland
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
China
State/province [2] 0 0
Guangdong
Country [3] 0 0
China
State/province [3] 0 0
Shanghai
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Guangzhou
Country [6] 0 0
France
State/province [6] 0 0
Strasbourg Cedex
Country [7] 0 0
France
State/province [7] 0 0
Toulouse Cedex 9
Country [8] 0 0
Germany
State/province [8] 0 0
Frankfurt
Country [9] 0 0
Germany
State/province [9] 0 0
Freiburg
Country [10] 0 0
Israel
State/province [10] 0 0
Ramat Gan
Country [11] 0 0
Italy
State/province [11] 0 0
MI
Country [12] 0 0
Italy
State/province [12] 0 0
MO
Country [13] 0 0
Japan
State/province [13] 0 0
Tokyo
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Korea
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seocho Gu
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Netherlands
State/province [17] 0 0
AZ
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Netherlands
State/province [19] 0 0
Rotterdam
Country [20] 0 0
Singapore
State/province [20] 0 0
Singapore
Country [21] 0 0
Spain
State/province [21] 0 0
Catalunya
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Taiwan
State/province [23] 0 0
Tainan
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei
Country [25] 0 0
Thailand
State/province [25] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01610336