Trial Outcomes & Findings for Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer (NCT NCT01277757)

Last Updated: 2018-12-19

Results Overview

Number of participants with response defined by RECIST version 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Up to 3 weeks after completion of study treatment, for up to 1 year

Results posted on

2018-12-19

Participant Flow

Recruitment Period: March 14, 2011 to November 27, 2013. Recruitment done at The University of Texas MD Anderson Cancer Center, Beth-Israel Deaconness, Columbia University Medical Center, Dana Farber Cancer Center and Vanderbilt University.

Of the 30 participants registered, two were ineligible, not treated therefore excluded from the trial outcomes.

Participant milestones

Participant milestones
Measure	Akt Inhibitor MK-2206 Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Akt Inhibitor MK-2206 Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Overall Study Disease Progression	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Akt Inhibitor MK-2206 n=30 Participants Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Age, Continuous	52.5 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 weeks after completion of study treatment, for up to 1 year

Population: Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.

Outcome measures

Outcome measures
Measure	Akt Inhibitor MK-2206 n=21 Participants Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST) Progressive Disease (PD)	20 participants
Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST) Stable Disease (SD)	0 participants
Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST) Complete Response (CR)	0 participants
Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST) Partial Response (PR)	1 participants

PRIMARY outcome

Timeframe: 4 weeks following beginning treatment, repeat confirmation 4-6 weeks following response, up to 1 year

Population: Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.

Only those participants who have measurable disease present at baseline, have received at least four doses of MK2206, and have had their disease re-evaluated will be considered evaluable for response. Response classified according the RECIST definitions, and re-evaluated for response every 12 weeks. (Note: Participants who exhibit objective disease progression prior to receiving four doses of therapy will also be considered evaluable.) In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response, and then revert to scheduled repeat imaging.

Outcome measures

Outcome measures
Measure	Akt Inhibitor MK-2206 n=21 Participants Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Number of Participants With Objective Response	8 participants

SECONDARY outcome

Timeframe: From start of treatment to time of progression or death or six months whichever occurs first, assessed at 6 months

Number of participants progression free at 6 months. PFS is defined as the duration of time from start of treatment, or time of progression or death, whichever occurs first. The PFS for this outcome was assessed at 6 months post treatment.

Outcome measures

Outcome measures
Measure	Akt Inhibitor MK-2206 n=27 Participants Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
6 Month Progression-free Survival (PFS)	0 participants

SECONDARY outcome

Timeframe: Response assessment 4 weeks from beginning of treatment, response recorded from the start of treatment until disease progression/recurrence, up to 1 year

Population: Two participants were not treated, and one was inevaluable.

The duration of the response is from the time response is achieved until disease progression is detected. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented. Response re-evaluated every 12 weeks. In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response.

Outcome measures

Outcome measures
Measure	Akt Inhibitor MK-2206 n=27 Participants Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Median Response Duration	5.8 months Interval 0.1 to 7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days after completion of study treatment, up to 1 year

Assessment of apoptosis by immunohistochemistry to active caspase-3. Initially, the goal was to look at predictors of response, but the number of responses was not enough to make a determination.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 2 weeks

Ki-67 will be scored as % positive cells to determine whether there is a change % Ki-67+ cells before treatment versus after 2 weeks of treatment. Initially, the goal was to look at predictors of response, but the number of responses was not enough to make a determination.

Outcome measures

Outcome data not reported

Adverse Events

Akt Inhibitor MK-2206

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Akt Inhibitor MK-2206 n=28 participants at risk Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Blood and lymphatic system disorders Hematocrit drop	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.

Other adverse events

Other adverse events
Measure	Akt Inhibitor MK-2206 n=28 participants at risk Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
Blood and lymphatic system disorders Examplex	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Abdominal pain	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Blood and lymphatic system disorders Activated partial thromboplastin time prolonged	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Alanine aminotransferase increased	7.1% 2/28 • Number of events 4 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Alkaline phosphatase increased	14.3% 4/28 • Number of events 6 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Skin and subcutaneous tissue disorders Alopecia	7.1% 2/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Blood and lymphatic system disorders Anemia	17.9% 5/28 • Number of events 9 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Anorexia	14.3% 4/28 • Number of events 20 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 2/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Aspartate aminotransferase increased	17.9% 5/28 • Number of events 10 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Musculoskeletal and connective tissue disorders Back pain	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Bloating	7.1% 2/28 • Number of events 3 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Blood bilirubin increased	3.6% 1/28 • Number of events 5 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Eye disorders Blurred vision	10.7% 3/28 • Number of events 4 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Musculoskeletal and connective tissue disorders Bone pain	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Reproductive system and breast disorders Breast pain	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Eye disorders Cataract	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
General disorders Chills	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Colonic obstruction	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Constipation	25.0% 7/28 • Number of events 9 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Cough	21.4% 6/28 • Number of events 6 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Creatinine increased	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Diarrhea	25.0% 7/28 • Number of events 35 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Nervous system disorders Dizziness	10.7% 3/28 • Number of events 3 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Eye disorders Dry eye	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Dry mouth	7.1% 2/28 • Number of events 4 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Skin and subcutaneous tissue disorders Dry skin	7.1% 2/28 • Number of events 3 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Dyspepsia	14.3% 4/28 • Number of events 15 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.7% 3/28 • Number of events 5 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
General disorders Edema limbs	10.7% 3/28 • Number of events 4 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
General disorders Fatigue	60.7% 17/28 • Number of events 52 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
General disorders Fever	14.3% 4/28 • Number of events 4 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
General disorders Flu like symptoms	3.6% 1/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Gastritis	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Gastroesophageal reflux disease	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Nervous system disorders Headache	14.3% 4/28 • Number of events 5 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Hiccups	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Hyperglycemia	14.3% 4/28 • Number of events 7 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Vascular disorders Hypertension	7.1% 2/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Hypoalbuminemia	7.1% 2/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Hypocalcemia	7.1% 2/28 • Number of events 3 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Metabolism and nutrition disorders Hypophosphatemia	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Vascular disorders Hypotension	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Infections and infestations Infections and infestations - (Other)	7.1% 2/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Psychiatric disorders Insomnia	10.7% 3/28 • Number of events 15 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Investigations Investigations - (Other)	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Infections and infestations Lung infection	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Mucositis oral	17.9% 5/28 • Number of events 12 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Musculoskeletal and connective tissue disorders Myalgia	17.9% 5/28 • Number of events 12 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Skin and subcutaneous tissue disorders Nail ridging	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.6% 1/28 • Number of events 3 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Nausea	35.7% 10/28 • Number of events 30 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - (Other)	7.1% 2/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Nervous system disorders Nervous system disorders - (Other)	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Investigations Neutrophil count decreased	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
General disorders Non-cardiac chest pain	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
General disorders Pain	32.1% 9/28 • Number of events 10 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 4/28 • Number of events 6 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Skin and subcutaneous tissue disorders Pain of skin	17.9% 5/28 • Number of events 7 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	3.6% 1/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Nervous system disorders Paresthesia	21.4% 6/28 • Number of events 16 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Nervous system disorders Peripheral sensory neuropathy	7.1% 2/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Investigations Platelet count decreased	3.6% 1/28 • Number of events 4 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Nervous system disorders Presyncope	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Skin and subcutaneous tissue disorders Pruritus	17.9% 5/28 • Number of events 6 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Skin and subcutaneous tissue disorders Rash maculo-papular	32.1% 9/28 • Number of events 38 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Eye disorders Scleral disorder	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Cardiac disorders Sinus bradycardia	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Cardiac disorders Sinus tachycardia	10.7% 3/28 • Number of events 6 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - (Other)	10.7% 3/28 • Number of events 4 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Respiratory, thoracic and mediastinal disorders Sore throat	10.7% 3/28 • Number of events 3 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Nervous system disorders Syncope	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Vascular disorders Thromboembolic event	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Eye disorders Vertigo	7.1% 2/28 • Number of events 2 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Gastrointestinal disorders Vomiting	28.6% 8/28 • Number of events 11 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Investigations Weight loss	7.1% 2/28 • Number of events 5 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.
Investigations White blood cell decreased	3.6% 1/28 • Number of events 1 • Adverse Event collection during each cycle, with a cycle duration being 28 days then followed for 3 weeks after removal from treatment or until death, whichever occurs first, for up to 1 year. Overall collection period: May 2011 to May 2014.

Additional Information

Funda Meric-Bernstam, MD/Chair, Investigational Cancer Therapeutics

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-563-4347

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60