Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Terminated
• CT.gov ID: NCT00718809
• Collaborator: (none)
• Enrollment: 21
• Locations: 2
• Arm: 1
• Duration (Months): 64
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This phase II trial is studying how well saracatinib works in treating patients with relapsed or refractory thymoma or thymic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Condition or Disease	Intervention/Treatment	Phase
Invasive Thymoma and Thymic Carcinoma; Recurrent Thymoma and Thymic Carcinoma; Stage III Thymoma; Stage IVA Thymoma; Stage IVB Thymoma	Drug: saracatinib	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To evaluate the objective response rate (complete response and partial response) in patients with relapsed or refractory thymoma or thymic carcinoma treated with AZD0530.

SECONDARY OBJECTIVES:

1. To evaluate the toxicity of AZD0530 in these patients. II. To evaluate the progression-free survival of these patients. III. To evaluate the overall survival of these patients. IV. To evaluate the disease control rate, defined as complete response, partial response, and stable disease, in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of AZD0530 for Patients With Relapsed/Refractory Thymic Malignancies (Thymoma and Thymic Carcinoma)
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Drug: saracatinib; Given orally; Other Names: AZD0530

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate (Complete and Partial Response) [Up to 5 years]

   Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.

Secondary Outcome Measures

1. Progression-free Survival [Time from the date of registration to the first reported outcome event, assessed up to 5 years]

   Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.

2. Overall Survival [Time from the date of registration to last reported date of survival, assessed up to 5 years]

   Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.

3. Disease Control Rate [Up to 5 years]

   Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis.

4. Expected Toxicities Including Skin Rashes and Diarrhea [Up to 5 years]

   Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed invasive thymoma or thymic carcinoma, meeting the following criteria:

• Relapsed or refractory disease

• Metastatic, unresectable disease

• Locally invasive disease allowed provided it is not resectable and has been previously treated

• Progressive disease

• Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan

• Must have received >= 1 prior chemotherapy regimen

• No active brain metastases

• Patients with previously treated brain metastases (surgical resection or radiotherapy) are eligible provided they have documented stable brain disease for >= 1 month after completion of therapy and are asymptomatic

• ECOG performance status 0-2

• Leukocytes >= 3,000/mm^3

• ANC >= 1,500/mm^3

• Platelet count >= 100,000/mm^3

• Hemoglobin > 9 g/dL

• Serum bilirubin < 2.0 times upper limit of normal (ULN)

• Transaminases =< 2.5 times ULN (< 5.0 times ULN if liver metastasis is present)

• Serum creatinine < 1.5 times ULN OR creatinine clearance > 50 mL/min

• Urine protein:creatinine ratio < 0.5 OR urine protein < 1,000 mg by 24-hour urine collection

• QTc < 460 msec

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 30 days after completion of study treatment

• No known history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530

• No other malignancies within the past 3 years, except curatively treated in situ carcinoma of the cervix or completely resected nonmelanoma skin cancer

• No concurrent active malignancies other than thymic malignancy

• No condition that impairs the ability to swallow AZD0350 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)

• No cardiac dysfunction including, but not limited to, any of the following:

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• History of ischemic heart disease

• Myocardial infarction within the past year

• No QTc prolongation or other significant ECG abnormalities

• No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 150 mm Hg or diastolic BP ≥ 95 mm Hg)

• No evidence of severe or uncontrolled systemic conditions that would make it undesirable to participate in the study or that would jeopardize compliance with the study, including any of the following:

• Severe hepatic impairment

• Interstitial lung disease (bilateral, diffuse, or parenchymal lung disease)

• Unstable or uncompensated respiratory condition

• Unstable or uncompensated cardiac condition

• No uncontrolled illness including, but not limited to, any of the following:

• Ongoing or active infection

• Mental health issues or social circumstances that would limit compliance with study requirements

• No prior src inhibitors

• At least 4 weeks since prior systemic therapy (6 weeks for carmustine or mitomycin C)

• At least 8 weeks since prior immunotherapy

• At least 4 weeks since prior octreotide

• Concurrent octreotide for pure red cell aplasia allowed provided patient continues on the same dose and schedule, has had a response to this drug, and has demonstrated progressive thymoma by radiography or physical exam

• At least 4 weeks since prior surgery and recovered

• At least 4 weeks since prior investigational agents

• At least 4 weeks since prior radiotherapy to measurable disease sites (2 weeks for palliative radiotherapy to metastatic sites) and recovered

• At least 7 days since prior and no concurrent active CYP3A4 agents or substances

• No other concurrent investigational or anticancer agents

• No concurrent combination antiretroviral therapy for HIV-positive patients

• Concurrent steroids allowed for treatment of a pre-existing autoimmune disorder or as antiemetic therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Hospitals and Clinics	Stanford	California	United States	94305
2	Indiana University Medical Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Patrick Loehrer, Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00718809
• Other Study ID Numbers: NCI-2009-00297; IUCRO-0214
• First Posted: Jul 21, 2008
• Last Update Posted: Jun 10, 2015
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: Carcinoma; Thymoma; Thymus Neoplasms; Saracatinib

Study Results

Participant Flow

Recruitment Details	This protocol was based on getting at least 12 eligible patients with thymoma to complete stage one. There are 12 eligible thymoma patients and also 9 thymic carcinoma patients. Since no patients in the thymoma group had a response of Complete or Partial response, the study ended without going to stage two.

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
STARTED	12	9
COMPLETED	0	0
NOT COMPLETED	12	9

Baseline Characteristics

Arm/Group Title	Thymoma	Thymic Carcinoma	Total
Arm/Group Description	Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Total of all reporting groups
Overall Participants	12	9	21
Age (Count of Participants)
<=18 years	0 0%	1 11.1%	1 4.8%
Between 18 and 65 years	11 91.7%	6 66.7%	17 81%
>=65 years	1 8.3%	2 22.2%	3 14.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.2 (12.25)	54.2 (17.94)	51.3 (14.76)
Sex: Female, Male (Count of Participants)
Female	7 58.3%	3 33.3%	10 47.6%
Male	5 41.7%	6 66.7%	11 52.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 8.3%	0 0%	1 4.8%
Not Hispanic or Latino	11 91.7%	9 100%	20 95.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 8.3%	2 22.2%	3 14.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 8.3%	0 0%	1 4.8%
White	8 66.7%	7 77.8%	15 71.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 16.7%	0 0%	2 9.5%

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate (Complete and Partial Response)
Description	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

All patients with at least one post baseline measurement.

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Measure Participants	12	9
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%

2. Secondary Outcome

Title	Progression-free Survival
Description	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.
Time Frame	Time from the date of registration to the first reported outcome event, assessed up to 5 years

Outcome Measure Data

Analysis Population Description

All patients who enrolled and received treatment.

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Measure Participants	12	9
Median (95% Confidence Interval) [months]	5.30	0.89

3. Secondary Outcome

Title	Overall Survival
Description	Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.
Time Frame	Time from the date of registration to last reported date of survival, assessed up to 5 years

Outcome Measure Data

Analysis Population Description

All patients who enrolled and received treatment

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Measure Participants	12	9
Median (95% Confidence Interval) [months]	37.47	6.68

4. Secondary Outcome

Title	Disease Control Rate
Description	Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

All patients who enrolled and received treatment

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Measure Participants	12	9
Median (95% Confidence Interval) [months]	5.72	3.55

5. Secondary Outcome

Title	Expected Toxicities Including Skin Rashes and Diarrhea
Description	Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

All patients

Arm/Group Title	Thymoma	Thymic Carcinoma
Arm/Group Description	Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Measure Participants	12	9
Number [participants]	10 83.3%	3 33.3%

Adverse Events

Time Frame	Beginning of treatment until the end of the study, up to 5 years
Arm/Group Title	Thymoma		Thymic Carcinoma
Arm/Group Description	Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.		Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All Cause Mortality
	Thymoma		Thymic Carcinoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Thymoma		Thymic Carcinoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)		1/9 (11.1%)
Gastrointestinal disorders
NAUSEA	1/12 (8.3%)	1	0/9 (0%)	0
VOMITING	1/12 (8.3%)	1	0/9 (0%)	0
Investigations
Unexpected Change in HEMOGLOBIN level	1/12 (8.3%)	1	0/9 (0%)	0
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	1/12 (8.3%)	1	0/9 (0%)	0
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)	0/12 (0%)	0	1/9 (11.1%)	1
PLEURAL EFFUSION (NON-MALIGNANT)	1/12 (8.3%)	1	0/9 (0%)	0
Vascular disorders
CNS CEREBROVASCULAR ISCHEMIA	1/12 (8.3%)	1	0/9 (0%)	0
THROMBOSIS/THROMBUS/EMBOLISM	1/12 (8.3%)	1	0/9 (0%)	0
VESSEL INJURY-VEIN - SVC	1/12 (8.3%)	1	0/9 (0%)	0
Other (Not Including Serious) Adverse Events
	Thymoma		Thymic Carcinoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/12 (100%)		9/9 (100%)
Blood and lymphatic system disorders
BLOOD/BONE MARROW	1/12 (8.3%)	1	0/9 (0%)	0
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)	1/12 (8.3%)	1	1/9 (11.1%)	1
LEUKOCYTES (TOTAL WBC)	1/12 (8.3%)	1	1/9 (11.1%)	1
LYMPHOPENIA	3/12 (25%)	3	1/9 (11.1%)	1
Cardiac disorders
MYOCARDITIS	1/12 (8.3%)	1	0/9 (0%)	0
PALPITATIONS	0/12 (0%)	0	1/9 (11.1%)	1
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA	1/12 (8.3%)	1	0/9 (0%)	0
Eye disorders
OCULAR/VISUAL	1/12 (8.3%)	1	0/9 (0%)	0
VISION-BLURRED VISION	1/12 (8.3%)	1	0/9 (0%)	0
Gastrointestinal disorders
ASCITES (NON-MALIGNANT)	0/12 (0%)	0	1/9 (11.1%)	1
CONSTIPATION	4/12 (33.3%)	4	1/9 (11.1%)	1
DIARRHEA	6/12 (50%)	6	3/9 (33.3%)	3
DISTENSION/BLOATING, ABDOMINAL	0/12 (0%)	0	1/9 (11.1%)	1
DYSPHAGIA (DIFFICULTY SWALLOWING)	0/12 (0%)	0	1/9 (11.1%)	1
FLATULENCE	0/12 (0%)	0	1/9 (11.1%)	1
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)	1/12 (8.3%)	1	0/9 (0%)	0
GASTROINTESTINAL - OTHER	0/12 (0%)	0	1/9 (11.1%)	1
HEARTBURN/DYSPEPSIA	4/12 (33.3%)	4	0/9 (0%)	0
HEMORRHAGE, GI - ANUS	0/12 (0%)	0	1/9 (11.1%)	1
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY	1/12 (8.3%)	1	0/9 (0%)	0
NAUSEA	11/12 (91.7%)	11	3/9 (33.3%)	3
PAIN - ABDOMEN NOS	4/12 (33.3%)	4	1/9 (11.1%)	1
TASTE ALTERATION (DYSGEUSIA)	3/12 (25%)	3	0/9 (0%)	0
VOMITING	6/12 (50%)	6	1/9 (11.1%)	1
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER	1/12 (8.3%)	1	2/9 (22.2%)	2
DYSPNEA (SHORTNESS OF BREATH)	1/12 (8.3%)	1	1/9 (11.1%)	1
EDEMA: HEAD AND NECK	1/12 (8.3%)	1	0/9 (0%)	0
EDEMA: LIMB	2/12 (16.7%)	2	1/9 (11.1%)	1
FATIGUE (ASTHENIA, LETHARGY, MALAISE)	9/12 (75%)	9	7/9 (77.8%)	7
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN)	3/12 (25%)	3	1/9 (11.1%)	1
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	1/12 (8.3%)	1	1/9 (11.1%)	1
PAIN - CHEST/THORAX NOS	4/12 (33.3%)	4	2/9 (22.2%)	2
PAIN - OTHER	0/12 (0%)	0	2/9 (22.2%)	2
RIGORS/CHILLS	3/12 (25%)	3	0/9 (0%)	0
SWEATING (DIAPHORESIS)	1/12 (8.3%)	1	0/9 (0%)	0
Infections and infestations
INFECTION - OTHER	1/12 (8.3%)	1	0/9 (0%)	0
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ORAL CAVITY-GUMS (GINGIVITIS)	1/12 (8.3%)	1	0/9 (0%)	0
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS	1/12 (8.3%)	1	0/9 (0%)	0
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS	1/12 (8.3%)	1	0/9 (0%)	0
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)	1/12 (8.3%)	1	1/9 (11.1%)	1
INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS)	1/12 (8.3%)	1	0/9 (0%)	0
INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS	1/12 (8.3%)	1	0/9 (0%)	0
Investigations
ALKALINE PHOSPHATASE	2/12 (16.7%)	2	3/9 (33.3%)	3
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)	2/12 (16.7%)	2	1/9 (11.1%)	1
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)	3/12 (25%)	3	2/9 (22.2%)	2
BICARBONATE, SERUM-LOW	1/12 (8.3%)	1	0/9 (0%)	0
CREATININE	1/12 (8.3%)	1	1/9 (11.1%)	1
HEMOGLOBIN	3/12 (25%)	3	1/9 (11.1%)	1
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - TRACHEA	1/12 (8.3%)	1	0/9 (0%)	0
NEUTROPHILS/GRANULOCYTES (ANC/AGC)	0/12 (0%)	0	1/9 (11.1%)	1
WEIGHT LOSS	2/12 (16.7%)	2	2/9 (22.2%)	2
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	1/12 (8.3%)	1	2/9 (22.2%)	2
ANOREXIA	7/12 (58.3%)	7	4/9 (44.4%)	4
CALCIUM, SERUM-LOW (HYPOCALCEMIA)	1/12 (8.3%)	1	0/9 (0%)	0
DEHYDRATION	0/12 (0%)	0	1/9 (11.1%)	1
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)	1/12 (8.3%)	1	0/9 (0%)	0
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)	4/12 (33.3%)	4	1/9 (11.1%)	1
POTASSIUM, SERUM-LOW (HYPOKALEMIA)	2/12 (16.7%)	2	1/9 (11.1%)	1
SODIUM, SERUM-LOW (HYPONATREMIA)	4/12 (33.3%)	4	1/9 (11.1%)	1
Musculoskeletal and connective tissue disorders
PAIN - BACK	4/12 (33.3%)	4	1/9 (11.1%)	1
PAIN - EXTREMITY-LIMB	1/12 (8.3%)	1	2/9 (22.2%)	2
PAIN - JOINT	1/12 (8.3%)	1	0/9 (0%)	0
PAIN - MUSCLE	1/12 (8.3%)	1	1/9 (11.1%)	1
Nervous system disorders
COGNITIVE DISTURBANCE	1/12 (8.3%)	1	0/9 (0%)	0
DIZZINESS	4/12 (33.3%)	4	0/9 (0%)	0
INSOMNIA	1/12 (8.3%)	1	0/9 (0%)	0
NEUROPATHY: SENSORY	1/12 (8.3%)	1	0/9 (0%)	0
PAIN - HEAD/HEADACHE	2/12 (16.7%)	2	1/9 (11.1%)	1
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS	0/12 (0%)	0	1/9 (11.1%)	1
SYNCOPE (FAINTING)	0/12 (0%)	0	1/9 (11.1%)	1
Psychiatric disorders
INSOMNIA	2/12 (16.7%)	2	0/9 (0%)	0
MENTAL STATUS	0/12 (0%)	0	1/9 (11.1%)	1
MOOD ALTERATION - ANXIETY	1/12 (8.3%)	1	0/9 (0%)	0
MOOD ALTERATION - DEPRESSION	1/12 (8.3%)	1	0/9 (0%)	0
Renal and urinary disorders
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS	1/12 (8.3%)	1	0/9 (0%)	0
PAIN - URETHRA	1/12 (8.3%)	1	0/9 (0%)	0
PROTEINURIA	3/12 (25%)	3	2/9 (22.2%)	2
RENAL/GENITOURINARY - OTHER	1/12 (8.3%)	1	0/9 (0%)	0
Reproductive system and breast disorders
PAIN - BREAST	1/12 (8.3%)	1	0/9 (0%)	0
PAIN - VAGINA	1/12 (8.3%)	1	0/9 (0%)	0
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS	1/12 (8.3%)	1	0/9 (0%)	0
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)	0/12 (0%)	0	1/9 (11.1%)	1
BRONCHOSPASM, WHEEZING	1/12 (8.3%)	1	0/9 (0%)	0
COUGH	8/12 (66.7%)	8	2/9 (22.2%)	2
DYSPNEA (SHORTNESS OF BREATH)	6/12 (50%)	6	5/9 (55.6%)	5
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - LUNG	1/12 (8.3%)	1	0/9 (0%)	0
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE	0/12 (0%)	0	1/9 (11.1%)	1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS	1/12 (8.3%)	1	0/9 (0%)	0
NASAL CAVITY/PARANASAL SINUS REACTIONS	1/12 (8.3%)	1	0/9 (0%)	0
PAIN - SINUS	1/12 (8.3%)	1	0/9 (0%)	0
PLEURAL EFFUSION (NON-MALIGNANT)	1/12 (8.3%)	1	1/9 (11.1%)	1
PNEUMONITIS/PULMONARY INFILTRATES	0/12 (0%)	0	1/9 (11.1%)	1
PNEUMOTHORAX	0/12 (0%)	0	1/9 (11.1%)	1
PULMONARY/UPPER RESPIRATORY - OTHER	2/12 (16.7%)	2	0/9 (0%)	0
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)	1/12 (8.3%)	1	0/9 (0%)	0
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)	2/12 (16.7%)	2	1/9 (11.1%)	1
PRURITUS/ITCHING	3/12 (25%)	3	0/9 (0%)	0
RASH/DESQUAMATION	2/12 (16.7%)	2	0/9 (0%)	0
RASH: ACNE/ACNEIFORM	4/12 (33.3%)	4	0/9 (0%)	0
SWEATING (DIAPHORESIS)	1/12 (8.3%)	1	0/9 (0%)	0
Vascular disorders
HYPOTENSION	0/12 (0%)	0	1/9 (11.1%)	1
THROMBOSIS/THROMBUS/EMBOLISM	1/12 (8.3%)	1	0/9 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.