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Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies (INVICTUS)

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ClinicalTrials.gov Identifier: NCT03353753
Recruitment Status : Active, not recruiting
First Posted : November 27, 2017
Results First Posted : April 23, 2021
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gastrointestinal Stromal Tumors
Interventions Drug: DCC-2618
Drug: Placebo Oral Tablet
Enrollment 129
Recruitment Details The first patient enrolled on 27 Feb 2018, with the last patient in (LPI) on 16 Nov 2018. The study is ongoing; Data cutoff date of 31 May 2019. Of the 129 patients enrolled in the double-blind period (ITT population), 85 patients were randomized to the ripretinib arm and 44 patients were randomized to the placebo arm.
Pre-assignment Details  
Arm/Group Title Ripretinib Placebo
Hide Arm/Group Description Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio
Period Title: Overall Study
Started 85 44 [1]
Completed [2] 46 35
Not Completed 39 9
[1]
1 patient was randomized but not dosed
[2]
Completed patients of the double-blind period are those that have entered the open-label period, or discontinued treatment due to death or confirmed progressive disease by IRR as of the cutoff of May 31, 2019.
Arm/Group Title Ripretinib Placebo Total
Hide Arm/Group Description Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Ripretinib vs. Placebo 2:1 ratio Total of all reporting groups
Overall Number of Baseline Participants 85 44 129
Hide Baseline Analysis Population Description
The baseline analysis population was the intent-to-treat (ITT) population, defined as those who signed the ICF and were randomized
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Category (years) Number Analyzed 85 participants 44 participants 129 participants
18 - 64 Years
57
  67.1%
22
  50.0%
79
  61.2%
65 - 74 Years
20
  23.5%
12
  27.3%
32
  24.8%
75 Years or Older
8
   9.4%
10
  22.7%
18
  14.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 44 participants 129 participants
Female
38
  44.7%
18
  40.9%
56
  43.4%
Male
47
  55.3%
26
  59.1%
73
  56.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 44 participants 129 participants
Hispanic or Latino
1
   1.2%
0
   0.0%
1
   0.8%
Not Hispanic or Latino
76
  89.4%
38
  86.4%
114
  88.4%
Unknown or Not Reported
8
   9.4%
6
  13.6%
14
  10.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 85 participants 44 participants 129 participants
Asian
4
   4.7%
5
  11.4%
9
   7.0%
Black or African American
8
   9.4%
2
   4.5%
10
   7.8%
White
64
  75.3%
33
  75.0%
97
  75.2%
Not Reported
8
   9.4%
4
   9.1%
12
   9.3%
Other
1
   1.2%
0
   0.0%
1
   0.8%
Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 44 participants 129 participants
US
40
  47.1%
20
  45.5%
60
  46.5%
Non-US
45
  52.9%
24
  54.5%
69
  53.5%
Number of Prior Systemic Anticancer Treatments  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 44 participants 129 participants
3
54
  63.5%
27
  61.4%
81
  62.8%
≥ 4
31
  36.5%
17
  38.6%
48
  37.2%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time interval between the date of randomization and the earliest documented evidence of the first disease progression based on the independent radiologic review or death due to any cause on initially assigned study treatment, whichever comes earlier, assessed at 26, 39, and 52 weeks.
Time Frame From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Ripretinib Placebo
Hide Arm/Group Description:
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Overall Number of Participants Analyzed 85 44
Median (95% Confidence Interval)
Unit of Measure: Weeks
27.6
(20.0 to 29.9)
4.1
(4.0 to 7.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided P-value
Method Log Rank
Comments Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)
Method of Estimation Estimation Parameter Hazard Ratio, log
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
0.09 to 0.25
Estimation Comments Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors [prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)]
2.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description The percentage of patients with a confirmed complete response or PR (CR: Disappearance of all target lesions and non-target lesions (if present at baseline); all lymph nodes must be non-pathological in size) or partial response (PR: >=30% decrease in the Sum of Diameters of target lesions and non-target lesions non-PD or NE or none at baseline; or target lesions CR and non-target lesions non-CR/Non-PD or NE) based on the independent radiologic review and during the initially assigned study treatment. To be assigned a status of a CR or PR, changes in tumor measurements must be confirmed by repeat CT or MRI assessments that must be performed at least 4 weeks after the criteria for response are first met.
Time Frame From date of randomization to the earliest date of disease progression or death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Ripretinib Placebo
Hide Arm/Group Description:
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Overall Number of Participants Analyzed 85 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
9.4
(4.2 to 17.7)
0
(0.0 to 8.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0504
Comments Two-sided P-value
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Time to Tumor Progression (TTP) Based on Independent Radiologic Review
Hide Description TTP is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review.
Time Frame From date of randomization to the earliest date of disease progression [through database cutoff 31-May-2019 (up to approximately 15 months)].
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Ripretinib Placebo
Hide Arm/Group Description:
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Overall Number of Participants Analyzed 85 44
Median (95% Confidence Interval)
Unit of Measure: Weeks
28
(20.0 to 36.4)
4.1
(4.0 to 7.6)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the interval between the date of randomization until the date of death or the date of last follow-up.
Time Frame From the date of randomization to the date of death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Ripretinib Placebo
Hide Arm/Group Description:
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Overall Number of Participants Analyzed 85 44
Median (95% Confidence Interval)
Unit of Measure: weeks
65.6
(53.6 to 65.6)
28.6
(17.9 to 50.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR and OS.
Method Log Rank
Comments Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.21 to 0.62
Estimation Comments Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors [prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)]
5.Secondary Outcome
Title Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning
Hide Description Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-item - Role Functioning. For the ripretinib arm the minimum and maximum for the outcome were -67 to 67; the placebo arm had a range of -83 to 67. The higher value represents a higher quality of life in disease-related symptoms.
Time Frame From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Ripretinib Placebo
Hide Arm/Group Description:
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Overall Number of Participants Analyzed 85 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.5  (27.31) -17.1  (30.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.
Method ANCOVA
Comments Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)
6.Secondary Outcome
Title Quality of Life & Disease-Related Symptoms - Physical Functioning
Hide Description Changes from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Physical Functioning. For the ripretinib arm, the minimum and maximum for the outcome were -33 to 53; the placebo arm had a range of -47 to 20. The higher value represents a higher quality of life in disease-related symptoms.
Time Frame From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Ripretinib Placebo
Hide Arm/Group Description:
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Overall Number of Participants Analyzed 85 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (16.03) -8.9  (19.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.
Method ANCOVA
Comments Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)
7.Secondary Outcome
Title Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale
Hide Description Change from baseline in EuroQol Visual Analogue Scale. For the ripretinib arm the minimum and maximum for the outcome were -43 to 91; the placebo arm had a range of -68 to 23. The higher value represents a higher quality of life in disease-related symptoms.
Time Frame From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Ripretinib Placebo
Hide Arm/Group Description:
Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
Overall Number of Participants Analyzed 85 43
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
3.7  (20.36) -8.9  (19.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame After Administration of the first dose of study drug and through 30 days after the last dose of study drug. A median of 28 weeks per participant for the ripretinib arm, and a median of 10 weeks per participant for the placebo arm.
Adverse Event Reporting Description Treatment-Emergent Adverse Events (TEAEs) are defined as any adverse event (all grades) that occurs after administration of the first dose of study drug and through 30 days after the last dose of study drug (Safety Population).The median treatment duration of the safety population for ripretinib arm was 23.86 weeks and placebo was 6 weeks during the double-blind period.
 
Arm/Group Title Ripretinib Placebo
Hide Arm/Group Description Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib). Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
All-Cause Mortality
Ripretinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   26/85 (30.59%)   26/43 (60.47%) 
Hide Serious Adverse Events
Ripretinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   26/85 (30.59%)   19/43 (44.19%) 
Blood and lymphatic system disorders     
Anemia † 1  3/85 (3.53%)  1/43 (2.33%) 
Cardiac disorders     
Cardiac Failure † 1  1/85 (1.18%)  0/43 (0.00%) 
Pericardial Effusion † 1  1/85 (1.18%)  0/43 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain † 1  4/85 (4.71%)  2/43 (4.65%) 
Nausea † 1  2/85 (2.35%)  0/43 (0.00%) 
Vomiting † 1  2/85 (2.35%)  0/43 (0.00%) 
Ascites † 1  1/85 (1.18%)  1/43 (2.33%) 
Constipation † 1  1/85 (1.18%)  0/43 (0.00%) 
Duodenal Ulcer † 1  1/85 (1.18%)  0/43 (0.00%) 
Fecaloma † 1  1/85 (1.18%)  0/43 (0.00%) 
Gastrointestinal Fistula † 1  1/85 (1.18%)  1/43 (2.33%) 
Gastroesophageal Reflux Disease † 1  1/85 (1.18%)  0/43 (0.00%) 
Small Intestinal Obstruction † 1  1/85 (1.18%)  1/43 (2.33%) 
Upper Gastrointestinal Hemorrhage † 1  1/85 (1.18%)  0/43 (0.00%) 
Gastrointestinal Perforation † 1  0/85 (0.00%)  1/43 (2.33%) 
General disorders     
Death † 1  3/85 (3.53%)  4/43 (9.30%) 
General Physical Health Deterioration † 1  1/85 (1.18%)  0/43 (0.00%) 
Asthenia † 1  0/85 (0.00%)  2/43 (4.65%) 
Pyrexia † 1  0/85 (0.00%)  1/43 (2.33%) 
Systemic Inflammatory Response Syndrome † 1  0/85 (0.00%)  1/43 (2.33%) 
Infections and infestations     
Liver Abscess † 1  1/85 (1.18%)  0/43 (0.00%) 
Sepsis † 1  1/85 (1.18%)  2/43 (4.65%) 
Upper Respiratory Tract Infection † 1  1/85 (1.18%)  0/43 (0.00%) 
Urinary Tract Infection † 1  1/85 (1.18%)  1/43 (2.33%) 
Septic Shock † 1  0/85 (0.00%)  1/43 (2.33%) 
Injury, poisoning and procedural complications     
Facial Bones Fracture † 1  0/85 (0.00%)  1/43 (2.33%) 
Investigations     
Blood Bilirubin Increased † 1  1/85 (1.18%)  0/43 (0.00%) 
Blood Creatinine Increased † 1  0/85 (0.00%)  1/43 (2.33%) 
Metabolism and nutrition disorders     
Hyperkaliemia † 1  1/85 (1.18%)  1/43 (2.33%) 
Hypoglycemia † 1  1/85 (1.18%)  0/43 (0.00%) 
Hypophosphatasemia † 1  1/85 (1.18%)  0/43 (0.00%) 
Dehydration † 1  0/85 (0.00%)  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal Chest Pain † 1  1/85 (1.18%)  0/43 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain † 1  0/85 (0.00%)  1/43 (2.33%) 
Psychiatric disorders     
Hallucinations, mixed † 1  1/85 (1.18%)  0/43 (0.00%) 
Mental Status Changes † 1  1/85 (1.18%)  0/43 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury † 1  1/85 (1.18%)  2/43 (4.65%) 
Urinary Retention † 1  0/85 (0.00%)  1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea † 1  1/85 (1.18%)  0/43 (0.00%) 
Hemoptysis † 1  0/85 (0.00%)  1/43 (2.33%) 
Pulmonary Edema † 1  0/85 (0.00%)  1/43 (2.33%) 
Vascular disorders     
Embolism † 1  1/85 (1.18%)  0/43 (0.00%) 
1
Term from vocabulary, MedDRA version 21.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ripretinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   84/85 (98.82%)   42/43 (97.67%) 
Blood and lymphatic system disorders     
Anemia † 1  12/85 (14.12%)  8/43 (18.60%) 
Gastrointestinal disorders     
Nausea † 1  33/85 (38.82%)  5/43 (11.63%) 
Abdominal Pain † 1  31/85 (36.47%)  13/43 (30.23%) 
Constipation † 1  29/85 (34.12%)  8/43 (18.60%) 
Diarrhea † 1  24/85 (28.24%)  6/43 (13.95%) 
Vomiting † 1  18/85 (21.18%)  3/43 (6.98%) 
Stomatitis † 1  9/85 (10.59%)  0/43 (0.00%) 
Abdominal Pain (Upper) † 1  8/85 (9.41%)  2/43 (4.65%) 
Dyspepsia † 1  7/85 (8.24%)  6/43 (13.95%) 
General disorders     
Fatigue † 1  36/85 (42.35%)  10/43 (23.26%) 
Peripheral Edema † 1  14/85 (16.47%)  3/43 (6.98%) 
Asthenia † 1  11/85 (12.94%)  6/43 (13.95%) 
Pyrexia † 1  6/85 (7.06%)  2/43 (4.65%) 
Investigations     
Weight Decreased † 1  16/85 (18.82%)  5/43 (11.63%) 
Blood Bilirubin Increased † 1  14/85 (16.47%)  0/43 (0.00%) 
Lipase Increased † 1  9/85 (10.59%)  0/43 (0.00%) 
Aspartate Aminotransferase Increased † 1  6/85 (7.06%)  2/43 (4.65%) 
Blood Alkaline Phosphatase Increased † 1  6/85 (7.06%)  1/43 (2.33%) 
Alanine Aminotransferase Increased † 1  5/85 (5.88%)  1/43 (2.33%) 
Metabolism and nutrition disorders     
Decreased Appetite † 1  23/85 (27.06%)  9/43 (20.93%) 
Hypophosphatemia † 1  9/85 (10.59%)  0/43 (0.00%) 
Hypokalemia † 1  5/85 (5.88%)  1/43 (2.33%) 
Musculoskeletal and connective tissue disorders     
Myalgia † 1  27/85 (31.76%)  5/43 (11.63%) 
Arthralgia † 1  15/85 (17.65%)  2/43 (4.65%) 
Muscle Spasms † 1  13/85 (15.29%)  2/43 (4.65%) 
Back Pain † 1  8/85 (9.41%)  2/43 (4.65%) 
Pain in Extremity † 1  8/85 (9.41%)  2/43 (4.65%) 
Musculoskeletal pain † 1  5/85 (5.88%)  3/43 (6.98%) 
Nervous system disorders     
Headache † 1  16/85 (18.82%)  2/43 (4.65%) 
Dizziness † 1  7/85 (8.24%)  3/43 (6.98%) 
Peripheral Sensory Neuropathy † 1  6/85 (7.06%)  1/43 (2.33%) 
Psychiatric disorders     
Insomnia † 1  8/85 (9.41%)  6/43 (13.95%) 
Anxiety † 1  7/85 (8.24%)  4/43 (9.30%) 
Depression † 1  6/85 (7.06%)  0/43 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea † 1  11/85 (12.94%)  0/43 (0.00%) 
Cough † 1  6/85 (7.06%)  1/43 (2.33%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  44/85 (51.76%)  2/43 (4.65%) 
Palmar-Plantar Erythrodysesthesia Syndrome † 1  18/85 (21.18%)  0/43 (0.00%) 
Dry Skin † 1  11/85 (12.94%)  3/43 (6.98%) 
Pruritus † 1  9/85 (10.59%)  2/43 (4.65%) 
Actinic keratosis † 1  5/85 (5.88%)  1/43 (2.33%) 
Dermatitis Acneiform † 1  5/85 (5.88%)  0/43 (0.00%) 
Hyperkeratosis † 1  5/85 (5.88%)  0/43 (0.00%) 
Pruritus Generalized † 1  5/85 (5.88%)  1/43 (2.33%) 
Rash Maculo-Papular † 1  5/85 (5.88%)  0/43 (0.00%) 
Vascular disorders     
Hypertension † 1  12/85 (14.12%)  2/43 (4.65%) 
1
Term from vocabulary, MedDRA version 21.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Neither Institution nor Investigator will submit for publication or public disclosure any publication or disclosure based on the results of the Study until after the first to occur of (a) publication of the Multi-Center Clinical Trial results; (b) notification by Sponsor that the Multi-Center Clinical Trial submission is no longer planned; or (c) the 12 month anniversary of the completion or early termination of the Multi-Center Clinical Trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: INVICTUS Clinical Team
Organization: Deciphera Pharmaceuticals, LLC
Phone: 7812096400
EMail: clinicaltrials@deciphera.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03353753    
Other Study ID Numbers: DCC-2618-03-001
First Submitted: November 20, 2017
First Posted: November 27, 2017
Results First Submitted: February 19, 2021
Results First Posted: April 23, 2021
Last Update Posted: May 12, 2021