Trial Outcomes & Findings for Docetaxel and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors (NCT NCT00390429)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Up to 36 months

Results posted on

2018-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I, Group A (1200 mg Erlotinib + 70mg/m2 Docetaxel) Original Dose Level Patients receive docetaxel IV over 1 hour on day 1 and oral Erlotinib hydrochloride once on days 2, 9, and 16 and Docetaxel on days 1 and 22. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. Docetaxel: Given IV Erlotinib hydrochloride: Given orally	Phase I, Group A (600 mg Erlotinib + 70mg/m2 Docetaxel) Patients receive docetaxel IV over 1 hour on day 1 and oral Erlotinib hydrochloride once on days 2, 9, and 16 and Docetaxel on days 1 and 22. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. Docetaxel: Given IV Erlotinib hydrochloride: Given orally	Phase I, Group B (Completed) Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Overall Study STARTED	5	12	25	39
Overall Study COMPLETED	5	12	25	39
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Docetaxel and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I, Arm A (Completed) n=17 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) n=25 Participants Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II n=39 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally	Total n=81 Participants Total of all reporting groups
Age, Continuous	63 years n=39 Participants	55 years n=41 Participants	61 years n=35 Participants	61 years n=31 Participants
Sex: Female, Male Female	6 Participants n=39 Participants	14 Participants n=41 Participants	24 Participants n=35 Participants	44 Participants n=31 Participants
Sex: Female, Male Male	11 Participants n=39 Participants	11 Participants n=41 Participants	15 Participants n=35 Participants	37 Participants n=31 Participants
Race/Ethnicity, Customized Race · African descent	1 Participants n=39 Participants	0 Participants n=41 Participants	2 Participants n=35 Participants	3 Participants n=31 Participants
Race/Ethnicity, Customized Race · White	15 Participants n=39 Participants	23 Participants n=41 Participants	35 Participants n=35 Participants	73 Participants n=31 Participants
Race/Ethnicity, Customized Race · East/South East Asian	1 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants	5 Participants n=31 Participants
Region of Enrollment United States	17 participants n=39 Participants	25 participants n=41 Participants	39 participants n=35 Participants	81 participants n=31 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Outcome measures

Outcome measures
Measure	Phase I, Arm A (Completed) n=17 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) n=25 Participants Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II n=39 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Safety and Toxicity of Erlotinib Hydrochloride and Docetaxel as Measured by NCI CTC v3.0 on Day 8 of Course 1 and on Day 1 of Every Subsequent Course (Phase I [Completed as of 12/01/2004])	17 Participants	25 Participants	39 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Population: All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.

Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Phase I, Arm A (Completed) n=39 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Response Rate (Phase II)	11 Participants	—	—

SECONDARY outcome

Timeframe: up to 36 months

Outcome measures

Outcome measures
Measure	Phase I, Arm A (Completed) n=17 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) n=25 Participants Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004]) Neutropenia	10 participants	16 participants	—
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004]) Febrile neutropenia	3 participants	4 participants	—
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004]) Hemoglobin	0 participants	1 participants	—
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004]) Diarrhea	0 participants	3 participants	—
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004]) Fatigue	0 participants	1 participants	—
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004]) Infection (without neutropenia)	1 participants	3 participants	—
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004]) Mucositis	0 participants	1 participants	—
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004]) Nausea	1 participants	0 participants	—
Comparison of Toxicity of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004]) Rash	0 participants	1 participants	—

SECONDARY outcome

Timeframe: up to 36 months

Population: Phase I, arm A, MTD: erlotinib 600-1000 mg d 2, 9, and 16; and docetaxel 70 mg/m\^2 d 1 on a 21-d cycle. Phase I, arm B, MTD: erlotinib 150-300 mg d 2 and 16; and docetaxel 70 mg/m\^2 d 1 on a 21-d cycle.

Maximum tolerated dose (MTD) defined as the highest dose level at which no more than one patient experienced DLT when at least 6 patients were treated at that dose level and were assessable for toxicity, graded according to NCI CTCAE 2.0.

Outcome measures

Outcome measures
Measure	Phase I, Arm A (Completed) n=12 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) n=25 Participants Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Maximum Tolerated Dose of Two Different Schedules of Erlotinib Hydrochloride and Docetaxel (Phase I [Completed as of 12/01/2004])	600 mg	200 mg	—

SECONDARY outcome

Timeframe: Up to 65 months

Outcome measures

Outcome measures
Measure	Phase I, Arm A (Completed) n=39 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Overall Survival (Phase II)	18.2 months Interval 0.0 to 65.0	—	—

SECONDARY outcome

Timeframe: Completion of study (up to 65 months)

Outcome measures

Outcome measures
Measure	Phase I, Arm A (Completed) n=39 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Progression-free Survival (Phase II)	4.1 months Interval 0.0 to 65.0	—	—

SECONDARY outcome

Timeframe: Completion of study (up to 36 months)

Treatment-related adverse events Grade ≥3 by NCI CTCAE 2.0.

Outcome measures

Outcome measures
Measure	Phase I, Arm A (Completed) n=39 Participants Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Frequency and Severity of Toxicities (Phase II) Neutropenia	14 participants	—	—
Frequency and Severity of Toxicities (Phase II) Febrile neutropenia	4 participants	—	—
Frequency and Severity of Toxicities (Phase II) Platelets	1 participants	—	—
Frequency and Severity of Toxicities (Phase II) Diarrhea	7 participants	—	—
Frequency and Severity of Toxicities (Phase II) Dehydration	2 participants	—	—
Frequency and Severity of Toxicities (Phase II) Fatigue	2 participants	—	—
Frequency and Severity of Toxicities (Phase II) Hypokalemia	1 participants	—	—
Frequency and Severity of Toxicities (Phase II) Hyponatremia	1 participants	—	—
Frequency and Severity of Toxicities (Phase II) Infection (without neutropenia)	1 participants	—	—
Frequency and Severity of Toxicities (Phase II) Myalgias	1 participants	—	—
Frequency and Severity of Toxicities (Phase II) Nausea	1 participants	—	—
Frequency and Severity of Toxicities (Phase II) Ocular	1 participants	—	—
Frequency and Severity of Toxicities (Phase II) Pain	1 participants	—	—
Frequency and Severity of Toxicities (Phase II) Stomatitis	1 participants	—	—

Adverse Events

Phase I, Arm A (Completed)

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Phase I, Arm B (Completed)

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Phase II

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I, Arm A (Completed) n=17 participants at risk Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) n=25 participants at risk Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II n=39 participants at risk Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/17	8.0% 2/25	0.00% 0/39
Respiratory, thoracic and mediastinal disorders Respiratory Failure	5.9% 1/17	0.00% 0/25	0.00% 0/39
Vascular disorders Hypotension	5.9% 1/17	0.00% 0/25	0.00% 0/39
Infections and infestations Sepsis	5.9% 1/17	4.0% 1/25	0.00% 0/39
Blood and lymphatic system disorders Neutropenia	0.00% 0/17	4.0% 1/25	2.6% 1/39
Blood and lymphatic system disorders Leukocytes	0.00% 0/17	4.0% 1/25	0.00% 0/39
Blood and lymphatic system disorders Hemoglobin	0.00% 0/17	4.0% 1/25	0.00% 0/39
Gastrointestinal disorders GI Bleed	0.00% 0/17	4.0% 1/25	0.00% 0/39
Infections and infestations Clinically Documented Infection	5.9% 1/17	0.00% 0/25	0.00% 0/39
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/17	4.0% 1/25	0.00% 0/39
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.00% 0/17	4.0% 1/25	0.00% 0/39
Metabolism and nutrition disorders Anorexia	0.00% 0/17	0.00% 0/25	2.6% 1/39
General disorders Fatigue	0.00% 0/17	0.00% 0/25	2.6% 1/39
Gastrointestinal disorders Mucositis	0.00% 0/17	0.00% 0/25	2.6% 1/39

Other adverse events

Other adverse events
Measure	Phase I, Arm A (Completed) n=17 participants at risk Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride once on days 2, 9, and 16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase I, Arm B (Completed) n=25 participants at risk Patients receive docetaxel as in group I and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients may then continue to receive erlotinib hydrochloride alone in the absence of unacceptable toxicity or disease progression. docetaxel: Given IV erlotinib hydrochloride: Given orally	Phase II n=39 participants at risk Patients receive docetaxel IV over 1 hour on day 1 and oral erlotinib hydrochloride at the MTD determined in group II of phase I once daily on days 2-16. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive erlotinib hydrochloride alone in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV erlotinib hydrochloride: Given orally
Blood and lymphatic system disorders Neutropenia	58.8% 10/17	64.0% 16/25	35.9% 14/39
Blood and lymphatic system disorders Febrile Neutropenia	17.6% 3/17	16.0% 4/25	10.3% 4/39
Blood and lymphatic system disorders Hemoglobin	0.00% 0/17	4.0% 1/25	0.00% 0/39
Blood and lymphatic system disorders Platelets	0.00% 0/17	0.00% 0/25	2.6% 1/39
Gastrointestinal disorders Diarrhea	0.00% 0/17	12.0% 3/25	17.9% 7/39
Metabolism and nutrition disorders Dehydration	0.00% 0/17	0.00% 0/25	5.1% 2/39
General disorders Fatigue	0.00% 0/17	4.0% 1/25	5.1% 2/39
Infections and infestations Infection (without neutropenia)	5.9% 1/17	12.0% 3/25	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Mucositis	0.00% 0/17	4.0% 1/25	0.00% 0/39
Gastrointestinal disorders Nausea	5.9% 1/17	0.00% 0/25	2.6% 1/39
Skin and subcutaneous tissue disorders Rash	0.00% 0/17	4.0% 1/25	0.00% 0/39
Metabolism and nutrition disorders Hypokalemia	0.00% 0/17	0.00% 0/25	2.6% 1/39
Metabolism and nutrition disorders Hyponatremia	0.00% 0/17	0.00% 0/25	2.6% 1/39
Musculoskeletal and connective tissue disorders Myalgias	0.00% 0/17	0.00% 0/25	2.6% 1/39
Eye disorders Ocular	0.00% 0/17	0.00% 0/25	2.6% 1/39
General disorders Pain	0.00% 0/17	0.00% 0/25	2.6% 1/39
Gastrointestinal disorders Stomatitis	0.00% 0/17	0.00% 0/25	2.6% 1/39

Additional Information

Analyst

University of California, Davis

Phone: 916-734-8053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place