A Study of LY2835219 in Japanese Participants With Advanced Cancer

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02014129
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 3
• Actual Duration (Months): 68.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Metastasis; Lymphoma	Drug: LY2835219	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of LY2835219 in Japanese Patients With Advanced Cancer
• Actual Study Start Date: Dec 18, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Aug 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 - 100 mg Abemaciclib 100 milligram (mg) abemaciclib administered orally every 12 hours (Q12H) in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	Drug: LY2835219; Administered orally; Other Names: abemaciclib
Experimental: Cohort 2 - 150 mg Abemaciclib 150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	Drug: LY2835219; Administered orally; Other Names: abemaciclib
Experimental: Cohort 3 - 200 mg Abemaciclib 200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	Drug: LY2835219; Administered orally; Other Names: abemaciclib

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT) [Cycle 1 = 32 days]

   DLT is defined as an adverse event between Day -3 and Day 29 of Cycle 1 that is possibly related to the study drug and fulfills any one of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

Secondary Outcome Measures

1. Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib [Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hours (hr) postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days)]

   Maximum plasma concentration on Day -3 and Day 28 of Cycle 1.

2. Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of Abemaciclib [Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hr postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days)]

   AUC on Day -3 and Day 28 of Cycle 1 are AUC from time zero to infinity [AUC(0-∞)] and AUC during one dosing interval at steady state (AUCτ,ss), respectively.

3. Percentage of Participants With a Tumor Response: Objective Response Rate (ORR) [Baseline to Measured Progressive Disease (Up To 24 months)]

   Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have histological or cytological evidence of a diagnosis of cancer (either a solid tumor or a lymphoma) that is advanced and/or metastatic

• Must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to provide clinical benefit for their disease

• Have the presence of measurable or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1, or the Revised Response Criteria for Malignant Lymphoma Guideline

• Have adequate organ function

• Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, and investigational therapy, for at least 21 days before the first dose of study drug and recovered from the acute effects of any such therapy

• Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug

• Females with child bearing potential: must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.

• A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 3 months after the last administration

• Have an estimated life expectancy of ≥12 weeks

• Are able to swallow capsules

Exclusion Criteria:

• Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication

• Have a medical history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (e.g., ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest

• Have a baseline with any of the following findings on screening electrocardiogram (ECG): ventricular tachycardia, ventricular fibrillation, abnormal QTc using Bazett's formula (QTcB) (defined as ≥470 milliseconds), or evidence of acute myocardial ischemia

• Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel)

• Have symptomatic central nervous system (CNS) malignancy or metastasis. For asymptomatic participants without history of CNS malignancy or metastases

• Have evidence or history of a leukemia

• Have received a stem-cell transplant. As an exception, a participant with lymphoma who received an autologous stem-cell transplant is eligible for the study, if more than 75 days have passed before the initial dose of study drug

• Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV], hepatitis B, or hepatitis C)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.	Tokyo		Japan	104-0045

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02014129
• Other Study ID Numbers: 15154; I3Y-JE-JPBC
• First Posted: Dec 18, 2013
• Last Update Posted: Aug 24, 2020
• Last Verified: Sep 15, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

Participant Flow

Recruitment Details	Participants completed the trial if they received at least one dose of study drug and met discontinuation criteria.

Arm/Group Title	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Arm/Group Description	100 milligram (mg) abemaciclib administered orally every 12 hours (Q12H) in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Period Title: Overall Study
STARTED	3	3	6
Received at Least One Dose of Study Drug	3	3	6
COMPLETED	3	3	6
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib	Total
Arm/Group Description	100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	Total of all reporting groups
Overall Participants	3	3	6	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (11.06)	63.0 (1.00)	56.0 (11.70)	59.1 (9.77)
Sex: Female, Male (Count of Participants)
Female	1 33.3%	1 33.3%	5 83.3%	7 58.3%
Male	2 66.7%	2 66.7%	1 16.7%	5 41.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	3 100%	3 100%	6 100%	12 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Japan	3 100%	3 100%	6 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Abemaciclib Dose-Limiting Toxicity (DLT)
Description	DLT is defined as an adverse event between Day -3 and Day 29 of Cycle 1 that is possibly related to the study drug and fulfills any one of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
Time Frame	Cycle 1 = 32 days

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and took at least 75% of planned dose in Cycle 1 or experienced a DLT in Cycle 1.

Arm/Group Title	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Arm/Group Description	100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Measure Participants	3	3	6
Count of Participants [Participants]	0 0%	0 0%	1 16.7%

2. Secondary Outcome

Title	Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Abemaciclib
Description	Maximum plasma concentration on Day -3 and Day 28 of Cycle 1.
Time Frame	Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hours (hr) postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable data for Cmax.

Arm/Group Title	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Arm/Group Description	100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Measure Participants	3	3	6
Cycle 1 Day -3	127 (51)	167 (40)	214 (87)
Cycle 1 Day 28	NA (NA)	NA (NA)	298 (64)

3. Secondary Outcome

Title	Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of Abemaciclib
Description	AUC on Day -3 and Day 28 of Cycle 1 are AUC from time zero to infinity [AUC(0-∞)] and AUC during one dosing interval at steady state (AUCτ,ss), respectively.
Time Frame	Cycle 1 Day -3: Predose, 1, 2, 4, 6, 8, 10, 24, 48 and 72 hr postdose; Cycle 1 Day 28: Predose, 1, 2, 4, 6, 8, 10 and 24 hr postdose (Cycle 1 = 32 days)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug and had evaluable data for AUC.

Arm/Group Title	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Arm/Group Description	100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Measure Participants	3	3	6
AUC(0-∞)	NA (NA)	4450 (39)	5480 (95)
AUCτ,ss (n=2,2,5)	NA (NA)	NA (NA)	3020 (73)

4. Secondary Outcome

Title	Percentage of Participants With a Tumor Response: Objective Response Rate (ORR)
Description	Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions.
Time Frame	Baseline to Measured Progressive Disease (Up To 24 months)

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Cohort 1 - 100 mg Abemaciclib	Cohort 2 - 150 mg Abemaciclib	Cohort 3 - 200 mg Abemaciclib
Arm/Group Description	100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.	200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
Measure Participants	3	3	6
Number [percentage of participants]	0 0%	0 0%	0 0%

Adverse Events

Adverse Event Reporting Description	All participants who received at least one dose of study drug.
Arm/Group Title	Cohort 1 - 100 mg Abemaciclib		Cohort 2 - 150 mg Abemaciclib		Cohort 3 - 200 mg Abemaciclib
Arm/Group Description	100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.		150 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.		200 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.
All Cause Mortality
	Cohort 1 - 100 mg Abemaciclib		Cohort 2 - 150 mg Abemaciclib		Cohort 3 - 200 mg Abemaciclib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cohort 1 - 100 mg Abemaciclib		Cohort 2 - 150 mg Abemaciclib		Cohort 3 - 200 mg Abemaciclib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		2/3 (66.7%)		2/6 (33.3%)
Gastrointestinal disorders
Gastric fistula	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0
Infections and infestations
Biliary tract infection	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0
Lung infection	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Vascular disorders
Deep vein thrombosis	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	Cohort 1 - 100 mg Abemaciclib		Cohort 2 - 150 mg Abemaciclib		Cohort 3 - 200 mg Abemaciclib
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)		6/6 (100%)
Blood and lymphatic system disorders
Anaemia	0/3 (0%)	0	1/3 (33.3%)	1	1/6 (16.7%)	1
Leukopenia	2/3 (66.7%)	2	0/3 (0%)	0	1/6 (16.7%)	12
Neutropenia	2/3 (66.7%)	2	1/3 (33.3%)	1	2/6 (33.3%)	12
Thrombocytopenia	2/3 (66.7%)	2	1/3 (33.3%)	1	0/6 (0%)	0
Eye disorders
Lacrimation increased	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Vitreous floaters	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Gastrointestinal disorders
Anal inflammation	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Ascites	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Constipation	0/3 (0%)	0	1/3 (33.3%)	1	2/6 (33.3%)	2
Diarrhoea	1/3 (33.3%)	1	2/3 (66.7%)	3	6/6 (100%)	8
Gastritis	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Nausea	1/3 (33.3%)	1	0/3 (0%)	0	3/6 (50%)	5
Stomatitis	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	3
Toothache	0/3 (0%)	0	1/3 (33.3%)	1	1/6 (16.7%)	1
Vomiting	1/3 (33.3%)	1	0/3 (0%)	0	4/6 (66.7%)	6
General disorders
Chest pain	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0
Fatigue	1/3 (33.3%)	1	0/3 (0%)	0	2/6 (33.3%)	2
Malaise	1/3 (33.3%)	1	0/3 (0%)	0	2/6 (33.3%)	3
Mucosal inflammation	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	2
Oedema peripheral	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Performance status decreased	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Pyrexia	1/3 (33.3%)	1	1/3 (33.3%)	1	2/6 (33.3%)	3
Immune system disorders
Seasonal allergy	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Infections and infestations
Biliary tract infection	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0
Cystitis	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Hordeolum	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Influenza	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Nasopharyngitis	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	3
Paronychia	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Rhinitis	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0
Skin infection	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0
Injury, poisoning and procedural complications
Post procedural haemorrhage	1/3 (33.3%)	1	1/3 (33.3%)	1	0/6 (0%)	0
Investigations
Alanine aminotransferase increased	0/3 (0%)	0	1/3 (33.3%)	1	1/6 (16.7%)	2
Aspartate aminotransferase increased	0/3 (0%)	0	2/3 (66.7%)	2	1/6 (16.7%)	1
Blood alkaline phosphatase increased	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Blood creatinine increased	2/3 (66.7%)	2	2/3 (66.7%)	2	5/6 (83.3%)	6
Electrocardiogram qt prolonged	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0
Haemoglobin decreased	0/3 (0%)	0	1/3 (33.3%)	1	2/6 (33.3%)	2
Lymphocyte count decreased	1/3 (33.3%)	2	1/3 (33.3%)	2	0/6 (0%)	0
Neutrophil count decreased	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	3
Platelet count decreased	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	4
Weight decreased	1/3 (33.3%)	1	1/3 (33.3%)	1	2/6 (33.3%)	2
White blood cell count decreased	0/3 (0%)	0	1/3 (33.3%)	1	4/6 (66.7%)	6
White blood cell count increased	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	2/3 (66.7%)	2	1/3 (33.3%)	1	3/6 (50%)	3
Dehydration	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0
Hypoalbuminaemia	1/3 (33.3%)	1	0/3 (0%)	0	1/6 (16.7%)	1
Hyponatraemia	1/3 (33.3%)	1	1/3 (33.3%)	1	0/6 (0%)	0
Musculoskeletal and connective tissue disorders
Myalgia	0/3 (0%)	0	1/3 (33.3%)	1	2/6 (33.3%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Tumour associated fever	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0
Nervous system disorders
Dysgeusia	0/3 (0%)	0	0/3 (0%)	0	3/6 (50%)	3
Headache	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	4
Somnolence	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	2
Psychiatric disorders
Insomnia	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	2
Renal and urinary disorders
Cystitis noninfective	0/3 (0%)	0	0/3 (0%)	0	2/6 (33.3%)	2
Proteinuria	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dysphonia	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Dyspnoea	0/3 (0%)	0	1/3 (33.3%)	1	1/6 (16.7%)	1
Hiccups	1/3 (33.3%)	1	0/3 (0%)	0	0/6 (0%)	0
Pleural effusion	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Rhinitis allergic	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1
Skin and subcutaneous tissue disorders
Dermatitis contact	0/3 (0%)	0	1/3 (33.3%)	1	0/6 (0%)	0
Pruritus	0/3 (0%)	0	1/3 (33.3%)	1	1/6 (16.7%)	1
Rash	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.