We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of RO5424802 in Patients With Non-Small Cell Lung Cancer Who Have ALK Mutation and Failed Crizotinib Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01801111
First Posted: February 28, 2013
Last Update Posted: July 6, 2017
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: August 19, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Squamous Non-Small Cell Lung Cancer
Interventions: Drug: erlotinib [Tarceva]
Drug: RO5452802

  Participant Flow
  Hide 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
Part 1 of study was planned to determine recommended Phase II Dose (RP2D) of alectinib to be used in Part 2. During the conduct of Part 1 for this study, RP2D was confirmed in Study NP28761 (NCT01871805). Hence Part 1 participants were merged into Part 2. Part 3 was post-progression treatment period.

Reporting Groups
  Description
Alectinib Participants received alectinib 600 milligrams (mg), capsule, orally, twice daily (BID), continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.

Participant Flow:   Overall Study
    Alectinib
STARTED   138 
COMPLETED   0 
NOT COMPLETED   138 
Treatment On-going                89 
Death                24 
On-going Survival Follow up                25 



  Baseline Characteristics
  Hide 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: All participants who received at least one dose of alectinib.

Reporting Groups
  Description
Alectinib Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.

Baseline Measures
   Alectinib 
Overall Participants Analyzed 
[Units: Participants]
 138 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.5  (11.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      77  55.8% 
Male      61  44.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Recommended Phase II Dose of Alectinib   [ Time Frame: Cycle 1 (up to 28 days) ]

2.  Primary:   Percentage of Participants With Dose Limiting Toxicities (DLTs)   [ Time Frame: Cycle 1 (up to 28 days) ]

3.  Primary:   Area Under the Plasma Concentration Time Curve From Time 0 to 10 Hour Post-dose (AUC[0-10]) of Alectinib   [ Time Frame: Day 1 and Day 21 of Cycle 1 ]

4.  Primary:   Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Independent Radiological Review Committee (IRC) in Response Evaluable (RE) Population   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

5.  Primary:   Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

6.  Secondary:   Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Naive Participants   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

7.  Secondary:   Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Response Evaluable Population   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

8.  Secondary:   Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Pretreated Participants   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

9.  Secondary:   Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Naive Participants   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

10.  Secondary:   Duration of Response   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

11.  Secondary:   Percentage of Participants With Progression or Death   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

12.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

13.  Secondary:   Percentage of Participants Who Died   [ Time Frame: Baseline up to death (any cause) or data cut off (18 August 2014, maximum follow up 53 weeks) ]

14.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline up to death (any cause) or data cutoff (18 August 2014, maximum follow up 53 weeks) ]

15.  Secondary:   Percentage of Participants Achieving CR, PR or Stable Disease (SD, Lasting ≥16 Weeks) in Response Evaluable Population   [ Time Frame: Baseline; every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reasons deemed by the investigator, or data cutoff (18 August 2014, maximum follow up 53 weeks) ]

16.  Secondary:   Percentage of Participants Achieving Objective Response (CR or PR) of Baseline Central Nervous System (CNS) Lesions As Assessed by IRC Based on RECIST   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

17.  Secondary:   Percentage of Participants Achieving Objective Response (CR or PR) of Baseline Central Nervous System (CNS) Lesions As Assessed by IRC Based on Radiology Assessment in Neuro-Oncology (RANO) Criteria   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

18.  Secondary:   Duration of Response in Participants With CNS Response (CR or PR) as Assessed by IRC Based on RECIST   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

19.  Secondary:   Duration of Response in Participants With CNS Response (CR or PR) as Assessed by IRC Based on RANO   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]

20.  Secondary:   Percentage of Participants With CNS Progression As Assessed by IRC Based on RECIST   [ Time Frame: Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Part 1 analysis was not conducted as during the conduct of the study the RP2D was confirmed in study NP28761 (NCT01871805).


  More Information
  Hide 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: NCT01801111     History of Changes
Other Study ID Numbers: NP28673
2012-004455-36 ( EudraCT Number )
First Submitted: February 20, 2013
First Posted: February 28, 2013
Results First Submitted: August 19, 2015
Results First Posted: May 26, 2016
Last Update Posted: July 6, 2017