Clinical Trial Results:
A Multicenter, International, Rollover Study of Alectinib in Patients with Anaplastic Lymphoma Kinase (ALK)-positive or Rearranged During Transfection (RET)-positive Cancer
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Summary
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EudraCT number |
2017-000207-24 |
Trial protocol |
ES FR PL IT |
Global end of trial date |
18 Sep 2025
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Oct 2026
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First version publication date |
02 Oct 2026
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BO39694
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03194893 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Hoffmann-La Roche
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Sponsor organisation address |
Grenzacherstrasse, 124, Basel, Switzerland, CH-4058
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Public contact |
Hoffmann-La Roche, Hoffmann-La Roche, +41 616878333, global.trial_information@roche.com
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Scientific contact |
Hoffmann-La Roche, Hoffmann-La Roche, +41 616878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Sep 2025
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Sep 2025
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main purpose of the study is to assess safety and provide continued treatment with alectinib to participants with ALK- or RET-positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib in the parent trial at the time of parent trial closure.
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Protection of trial subjects |
All study participants were required to read and sign an Informed Consent Form (ICF).
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Jul 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 13
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Country: Number of subjects enrolled |
Italy: 7
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Country: Number of subjects enrolled |
Türkiye: 6
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Country: Number of subjects enrolled |
Spain: 4
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Country: Number of subjects enrolled |
Russian Federation: 3
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Country: Number of subjects enrolled |
United States: 10
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Country: Number of subjects enrolled |
Hong Kong: 2
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Country: Number of subjects enrolled |
Korea, Republic of: 3
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Country: Number of subjects enrolled |
Poland: 2
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Worldwide total number of subjects |
50
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EEA total number of subjects |
26
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
35
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 50 participants with anaplastic lymphoma kinase (ALK)-positive or rearranged during transfection (RET)-positive cancer took part in the rollover study at 30 investigative sites across 9 countries from 5 July 2017 to 18 September 2025. | ||||||||||||||||
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Pre-assignment
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Screening details |
Participants continued alectinib treatment at the same dose received at the time of parent study closure without treatment interruption. No participants were enrolled in the crizotinib arm. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Alectinib | ||||||||||||||||
Arm description |
Participants with ALK-positive or RET-positive cancer who were deriving clinical benefit from alectinib treatment in a Roche-sponsored parent trial continued to receive alectinib at the same dose they received at the time of parent study closure (registered dose: 600 milligrams [mg]) taken orally twice daily (BID) until no further clinical benefit was expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Alectinib
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Investigational medicinal product code |
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Other name |
RO5424802
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Registered dose of alectinib is 600 mg BID, until no further clinical benefit was expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death.
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Baseline characteristics reporting groups
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Reporting group title |
Alectinib
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Reporting group description |
Participants with ALK-positive or RET-positive cancer who were deriving clinical benefit from alectinib treatment in a Roche-sponsored parent trial continued to receive alectinib at the same dose they received at the time of parent study closure (registered dose: 600 milligrams [mg]) taken orally twice daily (BID) until no further clinical benefit was expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Alectinib
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Reporting group description |
Participants with ALK-positive or RET-positive cancer who were deriving clinical benefit from alectinib treatment in a Roche-sponsored parent trial continued to receive alectinib at the same dose they received at the time of parent study closure (registered dose: 600 milligrams [mg]) taken orally twice daily (BID) until no further clinical benefit was expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death. | ||
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End point title |
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) [1] | ||||||||||||
End point description |
An AE is any untoward medical occurrence in a participant administered a study drug, regardless of causal relationship. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a medically important event. AESI included drug induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice and suspected transmission of infectious agent via study drug. Safety Population included all enrolled participants who received at least one dose of study drug.
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End point type |
Primary
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End point timeframe |
From study initiation until 4 weeks after the last dose (up to approximately 8.19 years)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number and Causes of Death on Study | ||||||||
End point description |
Safety Population included all enrolled participants who received at least one dose of study drug.
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End point type |
Secondary
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End point timeframe |
Up to approximately 8.19 years
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From study initiation until 4 weeks after the last dose (up to approximately 8.19 years)
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Adverse event reporting additional description |
Safety Population included all enrolled participants who received at least one dose of study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
28.0
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Reporting groups
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Reporting group title |
Alectinib 600mg BID
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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29 Nov 2019 |
Changes to the protocol are summarized: 1) Language had been modified to accommodate changes in local product information without requiring a protocol amendment by directing questions regarding dose reduction or discontinuation for hematologic and non-hematologic toxicities to the U.S. Package Insert or Crizotinib summary of product characteristics (SmPC) or local prescribing information. 2) The Medical Monitor name and contact information was updated. |
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18 Jan 2022 |
Changes to the protocol are summarized: 1) The table providing guidelines for the management of risks, adverse events, and laboratory abnormalities had been updated overall. 2) Hematologic findings from alectinib toxicity studies in animals had been provided to the section describing the risks associated with alectinib. 3) Benefit-risk assessment and guidance on concomitant administration of severe acute respiratory syndrome coronavirus 2 vaccines with alectinib had been added. 4) The Medical Monitor contact information had been updated. 5) The name of a Roche policy on data sharing had been corrected. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
