Study of Fruquintinib in Patients With Metastatic Colorectal Cancer

• Sponsor: Hutchison Medipharma Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02196688
• Collaborator: Fudan University (Other), Sun Yat-sen University (Other)
• Enrollment: 71
• Locations: 5
• Arms: 2
• Duration (Months): 19
• Patients Per Site: 14.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study.

This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after metastatic CRC second line or above standard chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: fruquintinib; Drug: placebo	Phase 2

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial to compare the efficacy and safety of Fruquintinib plus Best Supportive Care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy.

After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1.

Primary Efficacy Endpoint:

Progression free survival (PFS) (According to RECIST Version 1.1).

Secondary Efficacy Endpoints:

Objective Response Rate (ORR), Disease Control Rate (DCR), Overall Survival (OS).

Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI common terminology criteria for adverse events (CTC AE) Version 4.0.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial to Compare the Efficacy and Safety of Fruquintinib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Colorectal Cancer as 3rd or Above Therapy
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: treatment arm treatment arm- subjects will receive Fruquintinib 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.	Drug: fruquintinib; fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off; Other Names: HMPL-013
Placebo Comparator: control arm control arm- subjects will receive Fruquintinib placebo 5mg orally, once daily (QD), plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.	Drug: placebo; Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off; Other Names: HMPL-013 placebo

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [From randomization until the date of first documented progression or date of death from any cause, whichever came first.]

   PFS refers to the time interval between the randomization date and the initial record of PD or date of death, whichever is earlier. The presence of PD shall be determined in accordance with the result of the evaluation performed by the investigator, using with RECIST v1.1 criteria. The date of final tumor evaluation will be used as the censoring date for subjects who have not presented with disease progression or death by that date. The date of randomization will be used as the censoring date for subjects which have no death and post-baseline tumor evaluation. If a subject has no post-baseline tumor evaluation but recorded as dead, death will be count as PFS event.

Secondary Outcome Measures

1. Objective Response Rate (ORR) [From randomization up to progressive disease or end of treatment (EOT) due to any cause.]

   The ORR is defined as the rate of complete response (CR) or partial response (PR) as the best overall response (BOR), based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined by RECIST v1.1, for the ITT set of response evaluable subjects. Subjects who have no post-baseline tumor evaluation shall be regarded as subjects without ORR. Subjects who qualify for evaluation of CR or PR should have at least one available lesion for measurement with RECIST v1.1.

2. Disease Control Rate (DCR) [From randomization up to progressive disease or EOT due to any cause.]

   The DCR is defined as the rate of corroborant CR, PR and stable disease (SD) as the BOR, based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined according to RECIST v1.1, for the ITT set of response evaluable subjects.

3. Over Survival (OS) [From randomization until death due to any cause.]

   The OS refers to the time interval between the randomization date and the date of death (any cause). The final known date of survival will be used as the censoring date for subjects that have not been reported to have died by the time of analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ≥ 18 and ≤ 75 years of age , with ≥ 40 Kg

• Histological or cytological confirmed metastatic colorectal cancer

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Failed 2 or more lines of chemotherapy

• Adequate hepatic, renal, heart, and hematologic functions

• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)

• Signed and dated informed consent.

• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

Exclusion Criteria:

• Pregnant or lactating women

• Any factors that influence the usage of oral administration

• Central nervous system (CNS) metastasis

• One of the following conditions: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure

• Abuse of alcohol or drugs

• Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition

• Disability of serious uncontrolled intercurrence infection

• Proteinuria ≥ 2+ (1.0g/24hr)

• Evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness

• History of artery/venous thromboembolic events in 12 months, such as cerebral vascular accident (including transient ischemic attack) etc.

• History of acute myocardial infarction, acute coronary syndrome or coronary artery bypass graft (CABG) in 6 months

• Bone fracture or wounds that was not cured for a long time

• Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hutchison Medi Pharma Investigational Site	Beijing	Beijing	China	100071
2	Hutchison Medi Pharma Investigational Site	Guangzhou	Guangdong	China	510060
3	Hutchison Medi Pharma	Harbin	Heilongjiang	China	150081
4	Hutchison Medi Pharma Investigational Site	Hangzhou	Zhejiang	China	310016
5	Hutchison Medi Pharma Investigational Site	Shanghai		China	200032

Sponsors and Collaborators

• Hutchison Medipharma Limited
• Fudan University
• Sun Yat-sen University

Investigators

• Principal Investigator: Jin Li, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hutchison Medipharma Limited
• ClinicalTrials.gov Identifier: NCT02196688
• Other Study ID Numbers: 2012-013-00CH1
• First Posted: Jul 22, 2014
• Last Update Posted: Jun 16, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Hutchison Medipharma Limited: Colorectal cancer; Fruquintinib; 013
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

Participant Flow

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	treatment arm- subjects will receive Fruquintinib 5mg orally, Once Daily (QD), plus Best Supportive Care (BSC) for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off	control arm- subjects will receive Fruquintinib placebo 5mg orally, Once Daily (QD), plus Best Supportive Care (BSC) for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Period Title: Overall Study
STARTED	47	24
COMPLETED	40	23
NOT COMPLETED	7	1

Baseline Characteristics

Arm/Group Title	Treatment Arm	Control Arm	Total
Arm/Group Description	treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off	control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off	Total of all reporting groups
Overall Participants	47	24	71
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	41 87.2%	20 83.3%	61 85.9%
>=65 years	6 12.8%	4 16.7%	10 14.1%
Sex: Female, Male (Count of Participants)
Female	12 25.5%	7 29.2%	19 26.8%
Male	35 74.5%	17 70.8%	52 73.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	47 100%	24 100%	71 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
HAN	47 100%	24 100%	71 100%
NOT HAN	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	47 100%	24 100%	71 100%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Description	PFS refers to the time interval between the randomization date and the initial record of PD or date of death, whichever is earlier. The presence of PD shall be determined in accordance with the result of the evaluation performed by the investigator, using with RECIST v1.1 criteria. The date of final tumor evaluation will be used as the censoring date for subjects who have not presented with disease progression or death by that date. The date of randomization will be used as the censoring date for subjects which have no death and post-baseline tumor evaluation. If a subject has no post-baseline tumor evaluation but recorded as dead, death will be count as PFS event.
Time Frame	From randomization until the date of first documented progression or date of death from any cause, whichever came first.

Outcome Measure Data

Analysis Population Description

The intention-to-treat set will contain all subjects in the Randomized set (RND) set subjects will be classified according to randomized treatment. The intent-to-treat principle is preserved. The Intention to Treat (ITT) will be used for analyses of PFS, OS, ORR and DCR.

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off	control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Measure Participants	47	24
Median (95% Confidence Interval) [months]	4.731	0.986

2. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	The ORR is defined as the rate of complete response (CR) or partial response (PR) as the best overall response (BOR), based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined by RECIST v1.1, for the ITT set of response evaluable subjects. Subjects who have no post-baseline tumor evaluation shall be regarded as subjects without ORR. Subjects who qualify for evaluation of CR or PR should have at least one available lesion for measurement with RECIST v1.1.
Time Frame	From randomization up to progressive disease or end of treatment (EOT) due to any cause.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off	control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Measure Participants	47	24
Count of Participants [Participants]	1 2.1%	0 0%

3. Secondary Outcome

Title	Disease Control Rate (DCR)
Description	The DCR is defined as the rate of corroborant CR, PR and stable disease (SD) as the BOR, based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined according to RECIST v1.1, for the ITT set of response evaluable subjects.
Time Frame	From randomization up to progressive disease or EOT due to any cause.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off	control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Measure Participants	47	24
Count of Participants [Participants]	32 68.1%	5 20.8%

4. Secondary Outcome

Title	Over Survival (OS)
Description	The OS refers to the time interval between the randomization date and the date of death (any cause). The final known date of survival will be used as the censoring date for subjects that have not been reported to have died by the time of analysis.
Time Frame	From randomization until death due to any cause.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off	control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Measure Participants	47	24
Median (95% Confidence Interval) [months]	7.721	5.520

Adverse Events

Time Frame	Adverse event (AE) should be collected from first dose to 30 days after EOT. AEs and laboratory abnormalities that could not be restored or unexplained needed to be collected till recovery or until they could be explained. Serious adverse event (SAE) was collected from informed consent. Only SAEs related to the study drugs should be collected until 30 days after the last dose.
Arm/Group Title	Treatment Arm		Control Arm
Arm/Group Description	treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. fruquintinib: fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off		control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria. placebo: Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
All Cause Mortality
	Treatment Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/47 (80.9%)		19/24 (79.2%)
Serious Adverse Events
	Treatment Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/47 (25.5%)		5/24 (20.8%)
Gastrointestinal disorders
Obstruction intestinal	2/47 (4.3%)		0/24 (0%)
Pancreatitis acute	1/47 (2.1%)		0/24 (0%)
Upper gastrointestinal haemorrhage	1/47 (2.1%)		0/24 (0%)
Functional ileus	0/47 (0%)		1/24 (4.2%)
General disorders
Pyrexia	2/47 (4.3%)		0/24 (0%)
Sudden death	0/47 (0%)		1/24 (4.2%)
Platelet count decreased	0/47 (0%)		1/24 (4.2%)
Hepatobiliary disorders
Hepatic function abnormal	1/47 (2.1%)		0/24 (0%)
Hepatic damage	1/47 (2.1%)		0/24 (0%)
Jaundice cholestatic	1/47 (2.1%)		0/24 (0%)
Investigations
Blood bilirubin increased	2/47 (4.3%)		0/24 (0%)
Musculoskeletal and connective tissue disorders
Muscle weakness	0/47 (0%)		1/24 (4.2%)
Nervous system disorders
Dyskinesia	1/47 (2.1%)		0/24 (0%)
Hepatic coma	0/47 (0%)		1/24 (4.2%)
Respiratory, thoracic and mediastinal disorders
Haemoptysis	1/47 (2.1%)		0/24 (0%)
Vascular disorders
Hypertension	3/47 (6.4%)		0/24 (0%)
Embolism arterial	1/47 (2.1%)		0/24 (0%)
Superior vena cava syndrome	1/47 (2.1%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/47 (100%)		20/24 (83.3%)
Blood and lymphatic system disorders
ANAEMIA	7/47 (14.9%)		1/24 (4.2%)
Cardiac disorders
SINUS TACHYCARDIA	3/47 (6.4%)		1/24 (4.2%)
Ear and labyrinth disorders
TINNITUS	5/47 (10.6%)		0/24 (0%)
Endocrine disorders
HYPOTHYROIDISM	3/47 (6.4%)		0/24 (0%)
Gastrointestinal disorders
DIARRHOEA	15/47 (31.9%)		3/24 (12.5%)
STOMATITIS	12/47 (25.5%)		1/24 (4.2%)
CONSTIPATION	7/47 (14.9%)		1/24 (4.2%)
ABDOMINAL PAIN UPPER	6/47 (12.8%)		2/24 (8.3%)
VOMITING	6/47 (12.8%)		1/24 (4.2%)
ABDOMINAL PAIN	5/47 (10.6%)		2/24 (8.3%)
NAUSEA	5/47 (10.6%)		2/24 (8.3%)
ABDOMINAL DISTENSION	3/47 (6.4%)		2/24 (8.3%)
APHTHOUS STOMATITIS	3/47 (6.4%)		0/24 (0%)
General disorders
FATIGUE	15/47 (31.9%)		2/24 (8.3%)
MALAISE	10/47 (21.3%)		2/24 (8.3%)
PYREXIA	8/47 (17%)		3/24 (12.5%)
ASTHENIA	5/47 (10.6%)		2/24 (8.3%)
INFLUENZA LIKE ILLNESS	3/47 (6.4%)		1/24 (4.2%)
Hepatobiliary disorders
HEPATIC PAIN	2/47 (4.3%)		2/24 (8.3%)
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION	7/47 (14.9%)		1/24 (4.2%)
URINARY TRACT INFECTION	4/47 (8.5%)		0/24 (0%)
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED	15/47 (31.9%)		3/24 (12.5%)
BLOOD THYROID STIMULATING HORMONE INCREASED	11/47 (23.4%)		1/24 (4.2%)
ALANINE AMINOTRANSFERASE INCREASED	9/47 (19.1%)		1/24 (4.2%)
BLOOD BILIRUBIN INCREASED	9/47 (19.1%)		3/24 (12.5%)
OCCULT BLOOD POSITIVE	8/47 (17%)		3/24 (12.5%)
PLATELET COUNT DECREASED	8/47 (17%)		1/24 (4.2%)
BLOOD ALKALINE PHOSPHATASE	7/47 (14.9%)		3/24 (12.5%)
WHITE BLOOD CELL COUNT DECREASED	6/47 (12.8%)		0/24 (0%)
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED	5/47 (10.6%)		0/24 (0%)
NEUTROPHIL COUNT DECREASED	5/47 (10.6%)		0/24 (0%)
WEIGHT DECREASED	5/47 (10.6%)		0/24 (0%)
BLOOD PRESSURE INCREASED	4/47 (8.5%)		0/24 (0%)
BLOOD URINE PRESENT	3/47 (6.4%)		1/24 (4.2%)
GAMMA-GLUTAMYLTRANSFERASE INCREASED	0/47 (0%)		2/24 (8.3%)
BLOOD POTASSIUM DECREASED	0/47 (0%)		2/24 (8.3%)
HAEMOGLOBIN DECREASED	0/47 (0%)		3/24 (12.5%)
Metabolism and nutrition disorders
DECREASED APPETITE	14/47 (29.8%)		4/24 (16.7%)
HYPOALBUMINAEMIA	8/47 (17%)		1/24 (4.2%)
HYPERGLYCAEMIA	4/47 (8.5%)		0/24 (0%)
HYPOKALAEMIA	4/47 (8.5%)		0/24 (0%)
HYPONATRAEMIA	2/47 (4.3%)		2/24 (8.3%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	8/47 (17%)		0/24 (0%)
BACK PAIN	8/47 (17%)		2/24 (8.3%)
MYALGIA	2/47 (4.3%)		2/24 (8.3%)
PAIN IN EXTREMITY	2/47 (4.3%)		2/24 (8.3%)
Nervous system disorders
DIZZINESS	3/47 (6.4%)		0/24 (0%)
Psychiatric disorders
INSOMNIA	3/47 (6.4%)		1/24 (4.2%)
Renal and urinary disorders
PROTEINURIA	22/47 (46.8%)		5/24 (20.8%)
HAEMATURIA	6/47 (12.8%)		1/24 (4.2%)
Respiratory, thoracic and mediastinal disorders
DYSPHONIA	25/47 (53.2%)		2/24 (8.3%)
COUGH	9/47 (19.1%)		0/24 (0%)
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	30/47 (63.8%)		2/24 (8.3%)
NAIL DISCOLOURATION	9/47 (19.1%)		0/24 (0%)
RASH	7/47 (14.9%)		0/24 (0%)
DERMATITIS ACNEIFORM	5/47 (10.6%)		2/24 (8.3%)
RASH MACULO-PAPULAR	3/47 (6.4%)		0/24 (0%)
Vascular disorders
HYPERTENSION	21/47 (44.7%)		3/24 (12.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.