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 :
Completed
First Posted : November 27, 2017
Results First Posted : April 23, 2021
Last Update Posted : November 21, 2022
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Sponsor:
Deciphera Pharmaceuticals LLC
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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.
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Baseline Characteristics
Arm/Group Title | Ripretinib | Placebo | Total | |
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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 | |
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
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Age Category (years) | Number Analyzed | 85 participants | 44 participants | 129 participants |
18 - 64 Years |
57 67.1%
|
22 50.0%
|
79 61.2%
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65 - 74 Years |
20 23.5%
|
12 27.3%
|
32 24.8%
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75 Years or Older |
8 9.4%
|
10 22.7%
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18 14.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 44 participants | 129 participants | |
Female |
38 44.7%
|
18 40.9%
|
56 43.4%
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Male |
47 55.3%
|
26 59.1%
|
73 56.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 44 participants | 129 participants | |
Hispanic or Latino |
1 1.2%
|
0 0.0%
|
1 0.8%
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Not Hispanic or Latino |
76 89.4%
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38 86.4%
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114 88.4%
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Unknown or Not Reported |
8 9.4%
|
6 13.6%
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14 10.9%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 85 participants | 44 participants | 129 participants |
Asian |
4 4.7%
|
5 11.4%
|
9 7.0%
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Black or African American |
8 9.4%
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2 4.5%
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10 7.8%
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White |
64 75.3%
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33 75.0%
|
97 75.2%
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Not Reported |
8 9.4%
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4 9.1%
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12 9.3%
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Other |
1 1.2%
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0 0.0%
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1 0.8%
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Region
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 44 participants | 129 participants | |
US |
40 47.1%
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20 45.5%
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60 46.5%
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Non-US |
45 52.9%
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24 54.5%
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69 53.5%
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Number of Prior Systemic Anticancer Treatments
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 85 participants | 44 participants | 129 participants | |
3 |
54 63.5%
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27 61.4%
|
81 62.8%
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≥ 4 |
31 36.5%
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17 38.6%
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48 37.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
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):
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: | November 21, 2022 |