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A Study of CH5424802/RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01871805
Recruitment Status : Completed
First Posted : June 7, 2013
Results First Posted : February 12, 2016
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Intervention: Drug: RO5424802

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Alectinib 300 mg (Fasted): Phase I Participants received single dose of 20 or 40 milligrams (mg) alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg twice daily (BID) dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 600 mg (Fed): Phase II Participants received 150 mg alectinib capsules orally to make a dose of 600 mg BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.

Participant Flow for 2 periods

Period 1:   Phase I
    Alectinib 300 mg (Fasted): Phase I   Alectinib 460 mg (Fed): Phase I   Alectinib 600 mg (Fed): Phase I (20/40/150 mg)   Alectinib 760 mg (Fed): Phase I   Alectinib 900 mg (Fed): Phase I (20/40/150 mg)   Alectinib 600 mg (Fed): Phase II
STARTED   7   7   13   7   13   0 
COMPLETED   0   0   0   0   0   0 
NOT COMPLETED   7   7   13   7   13   0 
Death                6                3                5                2                6                0 
Alive on Treatment                0                3                5                4                3                0 
Alive in Survival Follow-up                1                0                3                1                4                0 
Lost to Follow-up                0                1                0                0                0                0 

Period 2:   Phase II
    Alectinib 300 mg (Fasted): Phase I   Alectinib 460 mg (Fed): Phase I   Alectinib 600 mg (Fed): Phase I (20/40/150 mg)   Alectinib 760 mg (Fed): Phase I   Alectinib 900 mg (Fed): Phase I (20/40/150 mg)   Alectinib 600 mg (Fed): Phase II
STARTED   0   0   0   0   0   87 
COMPLETED   0   0   0   0   0   0 
NOT COMPLETED   0   0   0   0   0   87 
Death                0                0                0                0                0                12 
Alive on Treatment                0                0                0                0                0                56 
Alive in Survival Follow-up                0                0                0                0                0                17 
Lost to Follow-up                0                0                0                0                0                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population included all participants who received any dose of alectinib.

Reporting Groups
  Description
Alectinib 300 mg (Fasted): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 460 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 600 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 760 mg (Fed): Phase I Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 900 mg (Fed): Phase I (20/40/150 mg) Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib 600 mg (Fed): Phase II Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Total Total of all reporting groups

Baseline Measures
   Alectinib 300 mg (Fasted): Phase I   Alectinib 460 mg (Fed): Phase I   Alectinib 600 mg (Fed): Phase I (20/40/150 mg)   Alectinib 760 mg (Fed): Phase I   Alectinib 900 mg (Fed): Phase I (20/40/150 mg)   Alectinib 600 mg (Fed): Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   13   7   13   87   134 
Age 
[Units: Participants]
Count of Participants
             
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7 100.0%      6  85.7%      12  92.3%      7 100.0%      10  76.9%      71  81.6%      113  84.3% 
>=65 years      0   0.0%      1  14.3%      1   7.7%      0   0.0%      3  23.1%      16  18.4%      21  15.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      2  28.6%      4  57.1%      3  23.1%      2  28.6%      9  69.2%      48  55.2%      68  50.7% 
Male      5  71.4%      3  42.9%      10  76.9%      5  71.4%      4  30.8%      39  44.8%      66  49.3% 


  Outcome Measures

1.  Primary:   Number of Participants With Dose Limiting Toxicities (DLTs) - Phase I   [ Time Frame: Cycle 1 of Phase I (21 days) ]

2.  Primary:   Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

3.  Secondary:   Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 105; data cut-off date 24 October 2014) ]

4.  Secondary:   Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1 at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

5.  Secondary:   Percentage of Participants With Disease Control by Investigator: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

6.  Secondary:   Progression-Free Survival (PFS) by IRC: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

7.  Secondary:   Percentage of Participants With Disease Progression or Death by IRC: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

8.  Secondary:   PFS by Investigator: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

9.  Secondary:   Overall Survival (OS) Time: Phase II   [ Time Frame: Baseline up to death (any cause) (data cutoff 24 October 2014, maximum follow up 60 weeks) ]

10.  Secondary:   DOR Assessed by IRC: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

11.  Secondary:   DOR Assessed by Investigator: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

12.  Secondary:   Percentage of Participants With Central Nervous System Objective Response Rate (CORR) Among Participants With Measurable Central Nervous System Lesions at Baseline According to RECIST v1.1 by IRC: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

13.  Secondary:   Percentage of Participants With COOR According to Response Assessment in Neuro-Oncology (RANO) by IRC: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

14.  Secondary:   Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]

15.  Secondary:   Percentage of Participants With CNS Progression According to RANO by IRC: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1 at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cutoff date of 24 October 2014) ]

16.  Secondary:   Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I   [ Time Frame: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 ]

17.  Secondary:   Cmax After Multiple Dose of Alectinib: Phase I   [ Time Frame: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 ]

18.  Secondary:   Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I   [ Time Frame: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 ]

19.  Secondary:   AUC From Time Zero to Last Measurable Concentration (AUClast) After Multiple Dose of Alectinib: Phase I   [ Time Frame: Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 ]

20.  Secondary:   Ctrough After Multiple Dose of Alectinib: Phase II   [ Time Frame: Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5 ]

21.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II   [ Time Frame: Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, last visit (Week 60; data cutoff date of 24 October 2014) ]

22.  Secondary:   Change From Baseline in EORTC QLQ-LC13: Phase II   [ Time Frame: Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, last visit (Week 60; data cutoff date of 24 October 2014) ]

23.  Secondary:   Duration of Response (DOR) Assessed by Investigator: Phase I   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 105; data cut-off date 24 October 2014) ]
Results not yet reported.   Anticipated Reporting Date:   09/2017  

24.  Secondary:   CNS Duration of Response (CDOR) According to RECIST v1.1 by IRC: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]
Results not yet reported.   Anticipated Reporting Date:   09/2017  

25.  Secondary:   CDOR According to RANO by IRC: Phase II   [ Time Frame: Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014) ]
Results not yet reported.   Anticipated Reporting Date:   09/2017  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01871805     History of Changes
Obsolete Identifiers: NCT01588028
Other Study ID Numbers: NP28761
First Submitted: May 28, 2013
First Posted: June 7, 2013
Results First Submitted: January 14, 2016
Results First Posted: February 12, 2016
Last Update Posted: October 25, 2017