Trial Outcomes & Findings for A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors (NCT NCT04644315)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Approximately 1 year

Results posted on

2023-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	ALK-positive Solid Tumors Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ALK-positive Solid Tumors Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
Overall Study Subject withdrawal of consent	1

Baseline Characteristics

The risk of participant re-identification is unacceptable for a population of n=1 and this value will therefore not be provided.

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Approximately 1 year

Population: Confirmed ORR was defined as the proportion of participants with a complete or partial response (CR or PR) confirmed at least 28 days after initial response.

Outcome measures

Outcome measures
Measure	ALK-positive Solid Tumors n=1 Participants Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	0 Percentage

SECONDARY outcome

Timeframe: 0 days

Population: BICR was not performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)

Population: DOR was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)

Population: PFS was defined as the time from the first dose of alectinib to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: CNS ORR was defined as the objective tumor response rate (CR or PR) of CNS lesions and could not be calculated due to an insufficient number of participants with the event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)

Population: CNS DOR was defined as the time from the first observation of CNS response until the first observation of CNS progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of study drug to death from any cause (up to 5 years)

Population: OS was defined as the time from first dose of study drug to death from any cause- and could not be calculated due to an insufficient number of participants with the event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 1 year

Outcome measures

Outcome measures
Measure	ALK-positive Solid Tumors n=1 Participants Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
Percentage of Participants With Adverse Events (AEs)	100 Percentage

SECONDARY outcome

Timeframe: Approximately 1 year

Outcome measures

Outcome measures
Measure	ALK-positive Solid Tumors n=1 Participants Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
Percentage of Participants With Serious Adverse Events (SAEs)	100 Percentage

SECONDARY outcome

Timeframe: Baseline up to 5 years

Population: Plasma concentration data was not collected as the data for one participant was not sufficient.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: CNS ORR was defined as the objective tumor response rate (CR or PR) of CNS lesions and could not be calculated due to an insufficient number of participants with the event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)

Population: DOR was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)

Population: PFS was defined as the time from the first dose of alectinib to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of study drug to death from any cause (up to 5 years)

Population: OS was defined as the time from first dose of study drug to death from any cause- and could not be calculated due to an insufficient number of participants with the event.

Outcome measures

Outcome data not reported

Adverse Events

ALK-positive Solid Tumors

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ALK-positive Solid Tumors n=1 participants at risk Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
Blood and lymphatic system disorders Anaemia	100.0% 1/1 • Number of events 1 • Approximately 1 year
Musculoskeletal and connective tissue disorders Myalgia	100.0% 1/1 • Number of events 1 • Approximately 1 year

Other adverse events

Other adverse events
Measure	ALK-positive Solid Tumors n=1 participants at risk Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
Nervous system disorders Hypoaesthesia	100.0% 1/1 • Number of events 1 • Approximately 1 year
Investigations Aspartate aminotransferase increased	100.0% 1/1 • Number of events 1 • Approximately 1 year
Nervous system disorders Headache	100.0% 1/1 • Number of events 1 • Approximately 1 year
General disorders Irritability	100.0% 1/1 • Number of events 1 • Approximately 1 year
Investigations Blood alkaline phosphatase increased	100.0% 1/1 • Number of events 1 • Approximately 1 year
Musculoskeletal and connective tissue disorders Muscular weakness	100.0% 1/1 • Number of events 1 • Approximately 1 year
Metabolism and nutrition disorders Weight decreased	100.0% 1/1 • Number of events 1 • Approximately 1 year
Nervous system disorders Dizziness	100.0% 1/1 • Number of events 1 • Approximately 1 year

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER