Trial Outcomes & Findings for Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3) (NCT NCT02695290)

Results Overview

Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Up to 98 days

Results posted on

2017-09-18

Participant Flow

This was an open-label, single-arm Phase IV study of afatinib in patients with stage IV or recurrent Non-Small Cell Lung Cancer who have poor performance status and whose tumors have the common epidermal growth factor receptor (EGFR) mutations, Exon 19 deletions or Exon 21(L858R) substitution mutations.

Participant milestones

Participant milestones
Measure	Afatinib Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Afatinib n=1 Participants Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Age, Continuous	62 Years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 98 days

Population: Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication.

Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.

Outcome measures

Outcome measures
Measure	Afatinib n=1 Participants Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib	0.0 Pecentage of Participants Confidence interval is not calculable as only one patient is analyzed.

SECONDARY outcome

Timeframe: Up to 98 days

Population: Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication. All data collected from the single patient who received study medication.

Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).

Outcome measures

Outcome measures
Measure	Afatinib n=1 Participants Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)	0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 98 days

Population: All data collected from the single patient who received study medication. As none of the AEs led to the dose reduction hence time to first dose reduction is not applicable.

Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.

Outcome measures

Outcome data not reported

Adverse Events

Afatinib

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Afatinib n=1 participants at risk Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Gastrointestinal disorders Diarrhoea	100.0% 1/1 • From first drug administration until 40 days after the last dose of study medication, up to 98 days
Skin and subcutaneous tissue disorders Rash	100.0% 1/1 • From first drug administration until 40 days after the last dose of study medication, up to 98 days
Skin and subcutaneous tissue disorders Pruritus	100.0% 1/1 • From first drug administration until 40 days after the last dose of study medication, up to 98 days
Gastrointestinal disorders Nausea	100.0% 1/1 • From first drug administration until 40 days after the last dose of study medication, up to 98 days
Gastrointestinal disorders Vomiting	100.0% 1/1 • From first drug administration until 40 days after the last dose of study medication, up to 98 days
General disorders Fatigue	100.0% 1/1 • From first drug administration until 40 days after the last dose of study medication, up to 98 days

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER