Trial Outcomes & Findings for Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer (NCT NCT01260701)

NCT ID: NCT01260701

Last Updated: 2016-01-18

Results Overview

Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 75 participants
• Primary outcome timeframe: Up to 2 years
• Results posted on: 2016-01-18

Participant Flow

Participant milestones

Measure	MK-2206 Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	75
Overall Study Eligible	71
Overall Study Eligible and Began Protocol Therapy	70
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	75

Reasons for withdrawal

Measure	MK-2206 Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	9
Overall Study Withdrawal by Subject	2
Overall Study Progression	53
Overall Study Death	2
Overall Study Not protocol specified	3
Overall Study Under review	1
Overall Study Ineligible	4
Overall Study Did not begin protocol therapy	1

Baseline Characteristics

Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Measure	MK-2206 n=70 Participants Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race/Ethnicity, Customized White	62 participants n=5 Participants
Race/Ethnicity, Customized Asian	5 participants n=5 Participants
Race/Ethnicity, Customized Unknown	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: Eligible patients who began protocol therapy.

Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Measure	MK-2206 n=70 Participants Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS)	5 months Interval 4.0 to 9.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: Eligible patients who began protocol therapy

PFS is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and without report of progression are censored at date of last contact. Progression is one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Outcome measures

Measure	MK-2206 n=70 Participants Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression Free Survival (PFS)	1.8 months Interval 1.7 to 1.8

SECONDARY outcome

Timeframe: Up to 2 years

Population: Eligible patients who began protocol therapy and were assessed for response.

Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. Any lymph nodes must have reduction in short axis to < 1.0 cm. Partial response (PR) is >= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed CR is two or more statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Confirmed PR is two or more statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Unconfirmed CR is one status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.

Outcome measures

Measure	MK-2206 n=68 Participants Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Response Rate (Complete and Partial, Confirmed and Unconfirmed)	1.5 percentage of participants Interval 0.0 to 7.9

SECONDARY outcome

Timeframe: Up to 2 years

Population: Eligible patients who received any treatment and were assessed for adverse events are included in this summary.

Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were possibly, probably or definitely related to protocol treatment are included.

Outcome measures

Measure	MK-2206 n=70 Participants Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Adult respiratory distress syndrome	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Alanine aminotransferase increased	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Alkaline phosphatase increased	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Allergic reaction	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Anemia	3 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Anorexia	3 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Aspartate aminotransferase increased	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Blood and lymphatic system disorders - Other	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Blood bilirubin increased	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Cardiac arrest	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dehydration	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Dyspnea	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Fatigue	4 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Gastric hemorrhage	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Gastroesophageal reflux disease	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hyperglycemia	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hypokalemia	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hyponatremia	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Hypoxia	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Lung infection	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Lymphocyte count decreased	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Nausea	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Non-cardiac chest pain	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pleural effusion	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pneumonitis	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Pruritus	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash acneiform	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Rash maculo-papular	2 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Respiratory failure	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Sinus bradycardia	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Sinus tachycardia	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Stroke	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Upper gastrointestinal hemorrhage	1 Participants
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Vomiting	2 Participants

Adverse Events

MK-2206

Serious events: 31 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK-2206 n=70 participants at risk Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Cardiac disorders Cardiac arrest	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Cardiac disorders Sinus tachycardia	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Abdominal distension	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Abdominal pain	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Colonic obstruction	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Constipation	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Dysphagia	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Esophageal hemorrhage	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Gastric hemorrhage	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Nausea	7.1% 5/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Obstruction gastric	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Rectal hemorrhage	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Small intestinal obstruction	4.3% 3/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Vomiting	4.3% 3/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Fatigue	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Non-cardiac chest pain	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Hepatobiliary disorders Cholecystitis	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Infections and infestations Lung infection	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Infections and infestations Peritoneal infection	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Infections and infestations Sepsis	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Infections and infestations Urinary tract infection	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Blood bilirubin increased	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Creatinine increased	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Anorexia	4.3% 3/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Dehydration	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Hyperglycemia	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Hypoalbuminemia	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Hypokalemia	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Musculoskeletal and connective tissue disorders Chest wall pain	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	12.9% 9/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Nervous system disorders Stroke	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Renal and urinary disorders Acute kidney injury	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Aspiration	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Skin and subcutaneous tissue disorders Pruritus	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Skin and subcutaneous tissue disorders Rash acneiform	1.4% 1/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Vascular disorders Thromboembolic event	2.9% 2/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.

Other adverse events

Measure	MK-2206 n=70 participants at risk Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	31.4% 22/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Cardiac disorders Sinus bradycardia	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Abdominal distension	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Abdominal pain	38.6% 27/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Constipation	22.9% 16/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Diarrhea	31.4% 22/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Dyspepsia	10.0% 7/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Dysphagia	14.3% 10/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Gastroesophageal reflux disease	11.4% 8/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Mucositis oral	10.0% 7/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Nausea	45.7% 32/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Gastrointestinal disorders Vomiting	27.1% 19/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Edema limbs	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Fatigue	68.6% 48/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Fever	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
General disorders Pain	8.6% 6/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Alanine aminotransferase increased	11.4% 8/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Alkaline phosphatase increased	30.0% 21/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Aspartate aminotransferase increased	15.7% 11/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Blood bilirubin increased	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Creatinine increased	10.0% 7/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Electrocardiogram QT corrected interval prolonged	11.4% 8/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Lymphocyte count decreased	20.0% 14/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Platelet count decreased	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations Weight loss	25.7% 18/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Investigations White blood cell decreased	10.0% 7/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Anorexia	38.6% 27/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Dehydration	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Hyperglycemia	40.0% 28/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Hypoalbuminemia	17.1% 12/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Hypocalcemia	10.0% 7/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Hypokalemia	8.6% 6/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Metabolism and nutrition disorders Hyponatremia	22.9% 16/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Musculoskeletal and connective tissue disorders Back pain	14.3% 10/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 5/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 5/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Nervous system disorders Dizziness	8.6% 6/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Nervous system disorders Headache	10.0% 7/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Nervous system disorders Peripheral sensory neuropathy	12.9% 9/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Psychiatric disorders Anxiety	11.4% 8/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Psychiatric disorders Depression	5.7% 4/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Psychiatric disorders Insomnia	10.0% 7/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Cough	8.6% 6/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.6% 6/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Skin and subcutaneous tissue disorders Dry skin	18.6% 13/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Skin and subcutaneous tissue disorders Pruritus	22.9% 16/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Skin and subcutaneous tissue disorders Rash acneiform	10.0% 7/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Skin and subcutaneous tissue disorders Rash maculo-papular	31.4% 22/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	7.1% 5/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Vascular disorders Hypertension	12.9% 9/70 • Up to 2 years Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.

Additional Information

Study Statistician

SWOG Statistical Center

Phone: 206-667-4623

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60