Trial Outcomes & Findings for Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM) (NCT NCT01110876)

Last Updated: 2021-08-25

Results Overview

Phase I assessment MTD Vorinostat in combination with escalating doses of Erlotinib and Temozolomide using conventional phase I design where 3 enrolled into first dose level, monitored for 3 weeks and if no dose-limiting toxicity (DLT) seen, 3 more enrolled at next dosage level. If 2/6 participants experience DLT, the previous (lower) dosage level declared MTD of vorinostat in combination with Erlotinib and Temozolomide. A maximum of 4 dosage levels utilized with deescalation by 2 dose levels if DLT is seen at the starting dose level. If no DLT noted after dose escalation to Level 4, these doses utilized as MTD for phase II.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Evaluated with each 28 day (+2 days) cycle, up to 24 weeks

Results posted on

2021-08-25

Participant Flow

Recruitment Period: June 21, 2011 to March 18, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.

Of the 14 participants registered in Phase I, two participants did not begin study due to financial reasons and were excluded. One of the six participants in Phase II one was not eligible and is also excluded. The study did not progress to the next stage of Phase II with adaptive randomized arms.

Participant milestones

Participant milestones
Measure	Phase I: Vorinostat + Erlotinib + Temozolomide Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m\^2 orally once daily on Days 1-7 and 15-21.	Phase II Part A 3-Drug Combination Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study. Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m\^2 orally once daily on Days 1-7 and 15-21.
Overall Study STARTED	13	5
Overall Study COMPLETED	13	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I Group 1: Vorinostat + Erlotinib + Temozolomide n=13 Participants Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m2 orally once daily on Days 1-7 and 15-21.	Phase II Part A 3-Drug Combination n=5 Participants Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study. Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m2 orally once daily on Days 1-7 and 15-21.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants	4 Participants n=4 Participants	16 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Continuous	48 years n=93 Participants	53 years n=4 Participants	51 years n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	1 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Region of Enrollment United States	13 participants n=93 Participants	5 participants n=4 Participants	18 participants n=27 Participants
Enzyme Inducing Anti-Convulsants (EIACs) EIACs	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Enzyme Inducing Anti-Convulsants (EIACs) NEIACs	12 Participants n=93 Participants	0 Participants n=4 Participants	12 Participants n=27 Participants

PRIMARY outcome

Timeframe: Evaluated with each 28 day (+2 days) cycle, up to 24 weeks

Population: One participant started later than 12 assigned to original MTD dose levels, and was excluded from this analysis.

Outcome measures

Outcome measures
Measure	Phase I Group 1: Vorinostat + Erlotinib + Temozolomide n=12 Participants Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m\^2 orally once daily on Days 1-7 and 15-21.
Maximum Tolerated Dose (MTD) of Vorinostat in Combination With Escalating Doses of Erlotinib and Temozolomide Vorinostat (mg) twice/day	200 mg
Maximum Tolerated Dose (MTD) of Vorinostat in Combination With Escalating Doses of Erlotinib and Temozolomide Erlotinib (mg)	200 mg

SECONDARY outcome

Timeframe: 6 months

Population: No data collected. The study did not progress to the next stage of Phase II with adaptive randomized arms.

This is an adaptive randomized phase II trial to Vorinostat + Erlotinib to Vorinostat + Erlotinib + Temozolomide in patients with recurrent GBM. The primary outcome is progression free survival (PFS). Patients will be randomized between the two arms using a Bayesian adaptive algorithm. Participants randomized equally between the two arms at the start of the trial (for the first 20 patients). Thereafter, as the trial progresses and data accrue, the randomization will become unbalanced in favor of the treatment that, on average, has better results in terms of failure time. Therefore, each successive patient is more likely to receive the treatment with better results, on average.

Outcome measures

Outcome data not reported

Adverse Events

Phase I Dose 0: Vorinostat 200 mg + Temozolomide 125 mg/m^2

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase I Dose -1: Vorinostat 200 mg + Temozolomide 100 mg/m^2

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase I EIACs: Vorinostat 400 mg + Temozolomide 125 mg/m^2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase II 3-Drug Combination

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

John de Groot, MD/Associate Professor, NEURO-ONCOLOGY

University of Texas (UT) MD Anderson Cancer Center

Phone: (713) 745-3072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Phase I Dose 0: Vorinostat 200 mg + Temozolomide 125 mg/m^2 n=6 participants at risk Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m\^2 orally once daily on Days 1-7 and 15-21.	Phase I Dose -1: Vorinostat 200 mg + Temozolomide 100 mg/m^2 n=6 participants at risk Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg twice daily on Days 1-21; Temozolomide 100 mg/m\^2 orally once daily on Days 1-7 and 15-21.	Phase I EIACs: Vorinostat 400 mg + Temozolomide 125 mg/m^2 n=1 participants at risk Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide for participant on enzyme inducing anticonvulsants (EIACs): Vorinostat 400 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 100 mg orally once daily on Days 1-21; Temozolomide 125 mg/m\^2 orally once daily on Days 1-7 and 15-21.	Phase II 3-Drug Combination n=5 participants at risk Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study. Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m\^2 orally once daily on Days 1-7 and 15-21.
General disorders Death	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Blood and lymphatic system disorders BILIRUBIN	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Nervous system disorders Central Nervous System (CNS) ISCHEMIA	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders DEHYDRATION	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders DIARRHEA	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
General disorders FATIGUE	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders HYPONATREMIA	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Infections and infestations INFECTION CLINICAL	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Nervous system disorders MENTAL STATUS	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders NAUSEA	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Blood and lymphatic system disorders PLATELETS, DECREASE	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Nervous system disorders SEIZURE	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Vascular disorders THROMBOSIS/THROMBUS/EMBOLISM	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Nervous system disorders Neurological Disorder	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	20.0% 1/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.

Other adverse events
Measure	Phase I Dose 0: Vorinostat 200 mg + Temozolomide 125 mg/m^2 n=6 participants at risk Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m\^2 orally once daily on Days 1-7 and 15-21.	Phase I Dose -1: Vorinostat 200 mg + Temozolomide 100 mg/m^2 n=6 participants at risk Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg twice daily on Days 1-21; Temozolomide 100 mg/m\^2 orally once daily on Days 1-7 and 15-21.	Phase I EIACs: Vorinostat 400 mg + Temozolomide 125 mg/m^2 n=1 participants at risk Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide for participant on enzyme inducing anticonvulsants (EIACs): Vorinostat 400 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 100 mg orally once daily on Days 1-21; Temozolomide 125 mg/m\^2 orally once daily on Days 1-7 and 15-21.	Phase II 3-Drug Combination n=5 participants at risk Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study. Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m\^2 orally once daily on Days 1-7 and 15-21.
Skin and subcutaneous tissue disorders ACNE	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders ALKALINE PHOSPHATASE	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Immune system disorders ALLERGIC RHINITIS	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Skin and subcutaneous tissue disorders ALOPECIA	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders ALT SGPT	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders ANOREXIA	50.0% 3/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	50.0% 3/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders AST SGOT	50.0% 3/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders BICARBONATE SERUM-LOW	50.0% 3/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	66.7% 4/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Blood and lymphatic system disorders BILIRUBIN	83.3% 5/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	66.7% 4/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	60.0% 3/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Eye disorders BLURRED VISION	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Nervous system disorders CNS ISCHEMIA	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Psychiatric disorders COGNITIVE DISTURBANCE	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Psychiatric disorders CONFUSION	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	66.7% 4/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	20.0% 1/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders CONSTIPATION	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	40.0% 2/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders CREATININE	83.3% 5/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	50.0% 3/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	20.0% 1/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders DEHYDRATION	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders DIARRHEA	100.0% 6/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 6/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	60.0% 3/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Nervous system disorders DIZZINESS	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	20.0% 1/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders DRY MOUTH	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	40.0% 2/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders DYSPHAGIA	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
General disorders FATIGUE	66.7% 4/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	66.7% 4/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 5/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
General disorders FEVER WITHOUT NEUTROPENIA	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Musculoskeletal and connective tissue disorders GAIT/WALKING	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	83.3% 5/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Ear and labyrinth disorders HEARING (W/O MONITORING)	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders HEARTBURN	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Blood and lymphatic system disorders HEMOGLOBIN	83.3% 5/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	66.7% 4/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	60.0% 3/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Blood and lymphatic system disorders HEMORRHAGE GU (KIDNEY)	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Blood and lymphatic system disorders HEMORRHAGE PULMONARY (NOSE)	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Gastrointestinal disorders HEMORRHOIDS	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Respiratory, thoracic and mediastinal disorders HICCOUGHS	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders HYPERCALCAEMIA	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders HYPERGLYCEMIA	66.7% 4/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	66.7% 4/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	60.0% 3/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders HYPERMAGNESEMIA	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Cardiac disorders HYPERTENSION	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders HYPOALBUMINEMIA	33.3% 2/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	50.0% 3/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	40.0% 2/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders HYPOCALCEMIA	16.7% 1/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	50.0% 3/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	40.0% 2/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
Metabolism and nutrition disorders HYPOGLYCEMIA	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/6 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	100.0% 1/1 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.	0.00% 0/5 • Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose. Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.