Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations (NCT NCT01372384)

Last Updated: 2016-02-02

Results Overview

Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.

Results posted on

2016-02-02

Participant Flow

In all 145 participants were screened, of these 6 participants were randomized; major reason for screen failure was negative mutation status.

Participant milestones

Participant milestones
Measure	Erlotinib Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
Overall Study STARTED	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
Overall Study Progression of disease	3

Baseline Characteristics

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib n=6 Participants Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
Age, Continuous	66.5 years STANDARD_DEVIATION 6.19 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants

PRIMARY outcome

Timeframe: Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.

Population: The Intent-to-treat (ITT population) included all patients with at least one valid post-baseline assessment.

Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.

Outcome measures

Outcome measures
Measure	Erlotinib n=6 Participants Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
Progression-free Survival (Tumour Assessments According to RECIST Criteria)	223 Days Interval 137.0 to 297.0

SECONDARY outcome

Timeframe: Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months)

Population: The ITT population included all patients with at least one valid post-baseline assessment. Only those participants available at the specified time points were analyzed (represented by n=X).

Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study.

Outcome measures

Outcome measures
Measure	Erlotinib n=6 Participants Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
Objective Response Rate (Investigator Assessed) Visit 4, SD, n=5	83.3 Percentage Interval 35.87 to 99.58
Objective Response Rate (Investigator Assessed) Visit 4, PR, n=1	16.7 Percentage Interval 0.42 to 64.13
Objective Response Rate (Investigator Assessed) Visit 6, SD, n=2	33.3 Percentage Interval 4.32 to 77.73
Objective Response Rate (Investigator Assessed) Visit 6, PR, n=2	33.3 Percentage Interval 4.32 to 77.73
Objective Response Rate (Investigator Assessed) Visit 6, PD, n=2	33.3 Percentage Interval 4.32 to 77.73
Objective Response Rate (Investigator Assessed) Visit 10, PR, n=2	33.3 Percentage Interval 4.32 to 77.73
Objective Response Rate (Investigator Assessed) Visit 10, PD, n=4	66.7 Percentage Interval 22.27 to 95.68
Objective Response Rate (Investigator Assessed) Visit 22, PD, n=6	100 Percentage Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.

Population: All participants who received at least one dose of study medication and had a safety assessment performed post baseline were included in the safety population. Participants were analyzed according to the first dose received during the study.

An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.

Outcome measures

Outcome measures
Measure	Erlotinib n=6 Participants Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
Safety: Incidence of Adverse Events Any AE	6 participants
Safety: Incidence of Adverse Events SAE	1 participants

SECONDARY outcome

Timeframe: Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.

Population: The ITT population included all patients with at least one valid post-baseline assessment.

The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Erlotinib n=6 Participants Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
Overall Survival	401 Days Interval 160.0 to 670.0

Adverse Events

Erlotinib

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib n=6 participants at risk Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
Respiratory, thoracic and mediastinal disorders Bronchopneumonia	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.

Other adverse events

Other adverse events
Measure	Erlotinib n=6 participants at risk Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
Investigations Blood bilirubin increased	33.3% 2/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Blood and lymphatic system disorders Anaemia	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Eye disorders Keratitis	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Reproductive system and breast disorders Orchitis	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Reproductive system and breast disorders Candidiasis (vulvovaginal)	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Rash maculo-papular	83.3% 5/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Skin and subcutaneous tissue disorders Alopecia	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Parasternal pain	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Abnormal loss of weight	33.3% 2/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Abnormal weight gain	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
Infections and infestations Forunculosis	16.7% 1/6 • Upto 24 months Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 61 6878333

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