Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Fruquintinib in Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02196688
Recruitment Status : Completed
First Posted : July 22, 2014
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Fudan University
Sun Yat-sen University
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: fruquintinib
Drug: placebo
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Arm Control Arm
Hide 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
Arm/Group Title Treatment Arm Control Arm Total
Hide 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 Number of Baseline Participants 47 24 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 24 participants 71 participants
<=18 years
0
   0.0%
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 24 participants 71 participants
Female
12
  25.5%
7
  29.2%
19
  26.8%
Male
35
  74.5%
17
  70.8%
52
  73.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 24 participants 71 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
47
 100.0%
24
 100.0%
71
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
ETHNICITY Number Analyzed 47 participants 24 participants 71 participants
HAN
47
 100.0%
24
 100.0%
71
 100.0%
NOT HAN
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 47 participants 24 participants 71 participants
47 24 71
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 47 24
Median (95% Confidence Interval)
Unit of Measure: months
4.731
(2.858 to 5.585)
0.986
(0.953 to 1.577)
2.Secondary Outcome
Title Objective Response Rate (ORR)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Control Arm
Hide 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

Overall Number of Participants Analyzed 47 24
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.1%
0
   0.0%
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Control Arm
Hide 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

Overall Number of Participants Analyzed 47 24
Measure Type: Count of Participants
Unit of Measure: Participants
32
  68.1%
5
  20.8%
4.Secondary Outcome
Title Over Survival (OS)
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm Control Arm
Hide 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

Overall Number of Participants Analyzed 47 24
Median (95% Confidence Interval)
Unit of Measure: months
7.721
(6.899 to 10.283)
5.520
(3.614 to 11.302)
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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm Control Arm
Hide 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 (%) Affected / at Risk (%)
Total   38/47 (80.85%)   19/24 (79.17%) 
Hide Serious Adverse Events
Treatment Arm Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   12/47 (25.53%)   5/24 (20.83%) 
Gastrointestinal disorders     
Obstruction intestinal  1  2/47 (4.26%)  0/24 (0.00%) 
Pancreatitis acute  1  1/47 (2.13%)  0/24 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/47 (2.13%)  0/24 (0.00%) 
Functional ileus  1  0/47 (0.00%)  1/24 (4.17%) 
General disorders     
Pyrexia  1  2/47 (4.26%)  0/24 (0.00%) 
Sudden death  1  0/47 (0.00%)  1/24 (4.17%) 
Platelet count decreased  1  0/47 (0.00%)  1/24 (4.17%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  1/47 (2.13%)  0/24 (0.00%) 
Hepatic damage  1  1/47 (2.13%)  0/24 (0.00%) 
Jaundice cholestatic  1  1/47 (2.13%)  0/24 (0.00%) 
Investigations     
Blood bilirubin increased  1  2/47 (4.26%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness  1  0/47 (0.00%)  1/24 (4.17%) 
Nervous system disorders     
Dyskinesia  1  1/47 (2.13%)  0/24 (0.00%) 
Hepatic coma  1  0/47 (0.00%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis  1  1/47 (2.13%)  0/24 (0.00%) 
Vascular disorders     
Hypertension  1  3/47 (6.38%)  0/24 (0.00%) 
Embolism arterial  1  1/47 (2.13%)  0/24 (0.00%) 
Superior vena cava syndrome  1  1/47 (2.13%)  0/24 (0.00%) 
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   47/47 (100.00%)   20/24 (83.33%) 
Blood and lymphatic system disorders     
ANAEMIA  1  7/47 (14.89%)  1/24 (4.17%) 
Cardiac disorders     
SINUS TACHYCARDIA  1  3/47 (6.38%)  1/24 (4.17%) 
Ear and labyrinth disorders     
TINNITUS  1  5/47 (10.64%)  0/24 (0.00%) 
Endocrine disorders     
HYPOTHYROIDISM  1  3/47 (6.38%)  0/24 (0.00%) 
Gastrointestinal disorders     
DIARRHOEA  1  15/47 (31.91%)  3/24 (12.50%) 
STOMATITIS  1  12/47 (25.53%)  1/24 (4.17%) 
CONSTIPATION  1  7/47 (14.89%)  1/24 (4.17%) 
ABDOMINAL PAIN UPPER  1  6/47 (12.77%)  2/24 (8.33%) 
VOMITING  1  6/47 (12.77%)  1/24 (4.17%) 
ABDOMINAL PAIN  1  5/47 (10.64%)  2/24 (8.33%) 
NAUSEA  1  5/47 (10.64%)  2/24 (8.33%) 
ABDOMINAL DISTENSION  1  3/47 (6.38%)  2/24 (8.33%) 
APHTHOUS STOMATITIS  1  3/47 (6.38%)  0/24 (0.00%) 
General disorders     
FATIGUE  1  15/47 (31.91%)  2/24 (8.33%) 
MALAISE  1  10/47 (21.28%)  2/24 (8.33%) 
PYREXIA  1  8/47 (17.02%)  3/24 (12.50%) 
ASTHENIA  1  5/47 (10.64%)  2/24 (8.33%) 
INFLUENZA LIKE ILLNESS  1  3/47 (6.38%)  1/24 (4.17%) 
Hepatobiliary disorders     
HEPATIC PAIN  1  2/47 (4.26%)  2/24 (8.33%) 
Infections and infestations     
UPPER RESPIRATORY TRACT INFECTION  1  7/47 (14.89%)  1/24 (4.17%) 
URINARY TRACT INFECTION  1  4/47 (8.51%)  0/24 (0.00%) 
Investigations     
ASPARTATE AMINOTRANSFERASE INCREASED  1  15/47 (31.91%)  3/24 (12.50%) 
BLOOD THYROID STIMULATING HORMONE INCREASED  1  11/47 (23.40%)  1/24 (4.17%) 
ALANINE AMINOTRANSFERASE INCREASED  1  9/47 (19.15%)  1/24 (4.17%) 
BLOOD BILIRUBIN INCREASED  1  9/47 (19.15%)  3/24 (12.50%) 
OCCULT BLOOD POSITIVE  1  8/47 (17.02%)  3/24 (12.50%) 
PLATELET COUNT DECREASED  1  8/47 (17.02%)  1/24 (4.17%) 
BLOOD ALKALINE PHOSPHATASE  1  7/47 (14.89%)  3/24 (12.50%) 
WHITE BLOOD CELL COUNT DECREASED  1  6/47 (12.77%)  0/24 (0.00%) 
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED  1  5/47 (10.64%)  0/24 (0.00%) 
NEUTROPHIL COUNT DECREASED  1  5/47 (10.64%)  0/24 (0.00%) 
WEIGHT DECREASED  1  5/47 (10.64%)  0/24 (0.00%) 
BLOOD PRESSURE INCREASED  1  4/47 (8.51%)  0/24 (0.00%) 
BLOOD URINE PRESENT  1  3/47 (6.38%)  1/24 (4.17%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  0/47 (0.00%)  2/24 (8.33%) 
BLOOD POTASSIUM DECREASED  1  0/47 (0.00%)  2/24 (8.33%) 
HAEMOGLOBIN DECREASED  1  0/47 (0.00%)  3/24 (12.50%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  14/47 (29.79%)  4/24 (16.67%) 
HYPOALBUMINAEMIA  1  8/47 (17.02%)  1/24 (4.17%) 
HYPERGLYCAEMIA  1  4/47 (8.51%)  0/24 (0.00%) 
HYPOKALAEMIA  1  4/47 (8.51%)  0/24 (0.00%) 
HYPONATRAEMIA  1  2/47 (4.26%)  2/24 (8.33%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  8/47 (17.02%)  0/24 (0.00%) 
BACK PAIN  1  8/47 (17.02%)  2/24 (8.33%) 
MYALGIA  1  2/47 (4.26%)  2/24 (8.33%) 
PAIN IN EXTREMITY  1  2/47 (4.26%)  2/24 (8.33%) 
Nervous system disorders     
DIZZINESS  1  3/47 (6.38%)  0/24 (0.00%) 
Psychiatric disorders     
INSOMNIA  1  3/47 (6.38%)  1/24 (4.17%) 
Renal and urinary disorders     
PROTEINURIA  1  22/47 (46.81%)  5/24 (20.83%) 
HAEMATURIA  1  6/47 (12.77%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
DYSPHONIA  1  25/47 (53.19%)  2/24 (8.33%) 
COUGH  1  9/47 (19.15%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders     
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  30/47 (63.83%)  2/24 (8.33%) 
NAIL DISCOLOURATION  1  9/47 (19.15%)  0/24 (0.00%) 
RASH  1  7/47 (14.89%)  0/24 (0.00%) 
DERMATITIS ACNEIFORM  1  5/47 (10.64%)  2/24 (8.33%) 
RASH MACULO-PAPULAR  1  3/47 (6.38%)  0/24 (0.00%) 
Vascular disorders     
HYPERTENSION  1  21/47 (44.68%)  3/24 (12.50%) 
1
Term from vocabulary, MedDRA (17.1)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Songhua Fan
Organization: Hutchison Medipharma Ltd
Phone: +86 21 2067 3058 ext 5058
EMail: songhuaf@hmplglobal.com
Layout table for additonal information
Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02196688    
Other Study ID Numbers: 2012-013-00CH1
First Submitted: July 14, 2014
First Posted: July 22, 2014
Results First Submitted: June 24, 2019
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019