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Trial record 78 of 317 for:    colon cancer | ( Map: Canada )

Phase II Study of Perindopril and Regorafenib in mCRC (PARICCA)

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ClinicalTrials.gov Identifier: NCT02651415
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
British Columbia Cancer Agency

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: Regorafenib
Drug: Perindopril
Enrollment 12
Recruitment Details Study conducted from August 2016 - November 2018. 12 Patients were enrolled but only 10 were evaluable.
Pre-assignment Details  
Arm/Group Title Single Arm Trial
Hide Arm/Group Description All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
Period Title: Overall Study
Started 12 [1]
Completed 10 [2]
Not Completed 2
[1]
12 patients were enrolled.
[2]
10 patients were evaluable.
Arm/Group Title Regorafenib and Perindopril
Hide Arm/Group Description

Phase II, open label, single arm trial of patient with refractory metastatic colorectal carcinoma (mCRC) treated with regorafenib (10 mg/day) and perindopril (4 mg/day). There will be no stratification in this study.

Regorafenib: Stivarga® will be used as per the marketed indication (“on label”), Coversyl will be used off-label and as such a Clinical Trial Application will be filed with Health Canada.

Regorafenib will be administered 160 mg daily for 21 days of a 28 day cycle. Regorafenib will be administered with low fat breakfast, one hour after perindopril. A low fat breakfast as defined by the Stivarga ® (regorafenib) Product Monograph is one that is <30% fat, ~300-550 calories.

Perindopril: COVERSYL® (perindopril erbumine) 4 mg will be administered daily for 21 days of a 28 day cycle. Perindopril will be administered orally, first thing in the morning on an empty stomach.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  60.0%
>=65 years
4
  40.0%
[1]
Measure Description: Number of participants aged less than or equal to 18 years, between 18 and 65 years, and greater than or equal to 65 years.
[2]
Measure Analysis Population Description: 12 participants were enrolled but only 10 participants were evaluable.
Age, Continuous   [1] [2] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
60.65
(49 to 72)
[1]
Measure Description: Median age of participants
[2]
Measure Analysis Population Description: 12 participants were enrolled but only 10 participants were evaluable.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
[1]
Measure Description: Number of male and female participants.
[2]
Measure Analysis Population Description: 12 participants were enrolled but only 10 participants were evaluable.
Race/Ethnicity, Customized   [1] [2] 
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 10 participants
5
Black Number Analyzed 10 participants
1
Caucasian Number Analyzed 10 participants
4
[1]
Measure Description: Number of Asian, Black, and Caucasian participants.
[2]
Measure Analysis Population Description: 12 participants were enrolled but only 10 participants were evaluable.
Region of Enrollment   [1] [2] 
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 10 participants
10
[1]
Measure Description: Number of participants for which regional information was collected.
[2]
Measure Analysis Population Description: 12 participants were enrolled but only 10 participants were evaluable.
1.Primary Outcome
Title Number of Participants That Have Any Grade HFSR Toxicity
Hide Description

The trial will measure the toxicities of HFSR in participants receiving both perindopril and regorafenib using the CTCAE v4.03 criteria.

The toxicity of HFSR will be expressed based on the number of participants in the study (N=10) who are experiencing HFSR of all grades.

Time Frame Up to Safety Follow-Up Visit (30 days +/- 7 days after permanently stopping study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:
All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
2.Secondary Outcome
Title The Number of Participants That Experienced Any Grade of Hypertension as Assessed by CTCAE v4.03 Criteria When Treated With a Combination of Regorafenib and Perindopril
Hide Description All grades of hypertension will be evaluated using CTCAE v4.03, weekly for the first six weeks while they are on the study drug, then every second week and during the 30-day follow-up period (Post therapy).
Time Frame Weekly for the first six weeks while on the study drug, then every second week and during the 30-day follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:
All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
6
  60.0%
3.Secondary Outcome
Title The Number of Participants That Experienced All Grade Toxicities as Assessed by CTCAE v4.03 Criteria When Treated With a Combination of Regorafenib and Perindopril
Hide Description All grades of adverse events (including HFSR) will be evaluated using CTCAE v4.03, at baseline and at D1 of each cycle while they are on the study drug and during the 30-day follow-up period (Post therapy).
Time Frame At baseline and at D1 of each cycle while on the study drug and during the 30-day follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:
All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
10
4.Secondary Outcome
Title Number of Participants With Maximal Severity of HFSR as Assessed by CTCAE v4.03 Criteria When Treated With a Combination of Regorafenib and Perindopril
Hide Description The number of participants that experienced an HFSR of grade 3 or above as assessed by CTCAE v4.03 criteria when treated with a combination of regorafenib and perindopril.
Time Frame Up to Safety Follow-Up Visit (30 days +/- 7 days after permanently stopping study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:
All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
5
  50.0%
5.Secondary Outcome
Title Median Time Course to Development of Worst Grade (Grade 3) HFSR as Assessed by CTCAE v4.03 Criteria When Treated With a Combination of Regorafenib and Perindopril
Hide Description Median time course for participants to develop worst grade 3 HFSR toxicity is defined as the time (days) from start date of study drug to date of first documented grade 3 HFSR toxicity and will be calculated only for patients who had a HFSR toxicity grade 3.
Time Frame p to Safety Follow-Up Visit (30 days +/- 7 days after permanently stopping study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:
All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: days
12
(9 to 83)
6.Secondary Outcome
Title Median Time to Progression Free Survival (PFS)
Hide Description Median time (in months) to PFS. PFS is defined as the time from start date of study drugs to the date of first documented disease progression (radiological or clinical) or death due to any cause, if death occurs before progression is documented. PFS will be evaluated based on RECIST v1.1 criteria, 20% progression or any new lesion.
Time Frame From start date of study drugs to the date of first documented disease progression or death due to any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:
All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: Months
2.60
(1.74 to 3.61)
Time Frame The PARICCA study was conducted from August 2016 to November 2018 and during this time period, adverse event (AE) data were collected. All grades of AE (including HFSR) were evaluated using CTCAE v4.03, at baseline and at D1 of each cycle while they are on the study drug and during the 30-day follow up period (Post therapy).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm Trial
Hide Arm/Group Description All patients in this single-arm trial will receive treatment with regorafenib and perindopril.
All-Cause Mortality
Single Arm Trial
Affected / at Risk (%)
Total   10/10 (100.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm Trial
Affected / at Risk (%)
Total   1/10 (10.00%) 
Gastrointestinal disorders   
RUQ Abdominal Pain; Pneumonia  1 [1]  1/10 (10.00%) 
Malignant Neoplasm, Grade 5  1 [2]  1/10 (10.00%) 
1
Term from vocabulary, CTCAE 4.03
Indicates events were collected by systematic assessment
[1]
Right Upper Quadrant (RUQ) Abdominal Pain; Pneumonia
[2]
Malignant Neoplasm, Grade 5
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm Trial
Affected / at Risk (%)
Total   10/10 (100.00%) 
Gastrointestinal disorders   
Abdominal pain  1 [1]  5/10 (50.00%) 
Mucositis oral  1 [2]  6/10 (60.00%) 
Diarrhea  1 [3]  5/10 (50.00%) 
Nausea  1 [4]  4/10 (40.00%) 
Constipation  1 [5]  4/10 (40.00%) 
Vomiting  1 [6]  3/10 (30.00%) 
Ascites  1 [7]  3/10 (30.00%) 
Rectal pain  1 [8]  2/10 (20.00%) 
Dysphagia  1 [9]  2/10 (20.00%) 
General disorders   
Fatigue  1 [10]  7/10 (70.00%) 
Fever  1 [11]  3/10 (30.00%) 
Non-cardiac chest pain  1 [12]  2/10 (20.00%) 
Localized edema  1 [13]  2/10 (20.00%) 
Pain  1 [14]  1/10 (10.00%) 
Chills  1 [15]  1/10 (10.00%) 
Infections and infestations   
Urinary tract infection  1 [16]  3/10 (30.00%) 
Investigations   
Increased AST  1 [17]  3/10 (30.00%) 
Weight loss  1 [18]  1/10 (10.00%) 
Blood bilirubin increased  1 [19]  2/10 (20.00%) 
Alkaline phosphatase increased  1 [20]  1/10 (10.00%) 
Lipase increased  1 [21]  1/10 (10.00%) 
INR increased  1 [22]  1/10 (10.00%) 
Metabolism and nutrition disorders   
Anorexia  1 [23]  6/10 (60.00%) 
Hypokalemia  1 [24]  2/10 (20.00%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1 [25]  5/10 (50.00%) 
Arthralgia  1 [26]  4/10 (40.00%) 
Pain in extremity  1 [27]  3/10 (30.00%) 
Back pain  1 [28]  2/10 (20.00%) 
Generalized muscle weakness  1 [29]  1/10 (10.00%) 
Cramps (leg)  1 [30]  1/10 (10.00%) 
Nervous system disorders   
Headache  1 [31]  3/10 (30.00%) 
Paresthesia  1 [32]  1/10 (10.00%) 
Psychiatric disorders   
Insomnia  1 [33]  1/10 (10.00%) 
Renal and urinary disorders   
Hematuria  1 [34]  1/10 (10.00%) 
Reproductive system and breast disorders   
Pelvic pain  1 [35]  2/10 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Hoarseness  1 [36]  4/10 (40.00%) 
Dyspnea  1 [37]  2/10 (20.00%) 
Cough  1 [38]  2/10 (20.00%) 
Epistaxis  1 [39]  1/10 (10.00%) 
Haemoptysis  1 [40]  1/10 (10.00%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome  1 [41]  7/10 (70.00%) 
Rash maculo-papular  1 [42]  4/10 (40.00%) 
Dry skin  1 [43]  3/10 (30.00%) 
Erythema multiforme  1 [44]  1/10 (10.00%) 
Pruritus  1 [45]  1/10 (10.00%) 
Vascular disorders   
Hypertension  1 [46]  6/10 (60.00%) 
1
Term from vocabulary, CTCAE 4.03
Indicates events were collected by systematic assessment
[1]
Pain, abdomen
[2]
Oral mucositis (dry mouth, sore throat, mucosal infection)
[3]
Diarrhoea
[4]
Nausea
[5]
Constipation
[6]
Vomiting
[7]
Ascites
[8]
Rectal/anal pain
[9]
Dysphagia (difficulty swallowing)
[10]
Fatigue
[11]
Fever (pyrexia)
[12]
Non-cardiac chest pain
[13]
Oedema (ankle)
[14]
Pain, soles of feet, toe
[15]
Chills
[16]
Infection (UTI)
[17]
Increased aspartate aminotransferase (AST)
[18]
Weight loss
[19]
Hyperbilirubinaemia
[20]
Increased alkaline phosphatase
[21]
Increased lipase
[22]
Elevated international normalized ratio (INR)
[23]
Anorexia
[24]
Hypokalaemia
[25]
Muscle pain (myalgia)
[26]
Arthralgia (joint pain)
[27]
Pain extremity/neuralgia
[28]
Back pain
[29]
Weakness
[30]
Cramps (leg)
[31]
Headache
[32]
Paraesthesia
[33]
Insomnia
[34]
Haematuria
[35]
Thigh, groin, pelvic pain
[36]
Voice changes/hoarse voice
[37]
Dyspnoea (shortness of breath)
[38]
Dry cough
[39]
Nose bleed (epistaxis)
[40]
Haemoptysis (spitting blood)
[41]
Hand-foot skin reaction
[42]
Rash or desquamation
[43]
Dry skin
[44]
Erythaema face
[45]
Pruritis (itchy)
[46]
Hypertension
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Barbara Melosky
Organization: BC Cancer
Phone: 604-877-6000
EMail: bmelosky@bccancer.bc.ca
Publications:
Li J, Qin S, Yau T et al. CONCUR: a randomized double-blind placebo controlled phase 3 study of regorafenib monotherapy in Asian patients with previously treated metastatic colorectal cancer (mCRC). Ann Oncol 2014; 25 (Suppl 2): ii114-ii115.
Taddei S: New evidence for entothelial protection. Medicographia, a Servier publication Vol 34:17-23, 2012
Layout table for additonal information
Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02651415     History of Changes
Other Study ID Numbers: H15-02424
First Submitted: January 6, 2016
First Posted: January 11, 2016
Results First Submitted: January 25, 2019
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019