GIST With D842V Mutated PDGFRA GenePhase 3NCT02847429
Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
A Phase 3 study testing Crenolanib in people with GIST With D842V Mutated PDGFRA Gene, run by Arog Pharmaceuticals, Inc. at 23 sites in 7 countries.
Trial summary
This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIST With D842V Mutated PDGFRA Gene
- What is being tested?
- Crenolanib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 23 sitesin 7 countries
- Study dates
- Aug 2016to Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
- Measurable disease as per modified RECIST 1.1
- A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization
- Subjects (male or female) ≥ 18 years of age
- Female subjects with reproductive potential must have negative serum or urine pregnancy test
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Who cannot join
- Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
- Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug's half-life in subject is known) prior to randomization, whichever is shorter
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
United States6 sites
Duke Cancer Institute
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
University of Miami
Miami, Florida, 33136
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health and Science University
Portland, Oregon, 97239
Sarcoma Oncology Center
Santa Monica, California, 90403
France4 sites
Institut Bergonie
Bordeaux
Centre Leon Berard
Lyon, 69008
La Timone University Hospital
Marseille
Centre Hospitalier Universitaire (CHU) de Reims
Reims
Italy4 sites
Policlinico S. Orsola-Malpighi
Bologna
Istituto Nazionale Tumori
Milan, 20133
Institut Regina Elena / IFO
Rome
Candiolo Cancer Institute - FPO, IRCCS
Turin
Spain4 sites
Vall d'Hebron University Hospital
Barcelona
Hospital Universitario Puerta de Hierro
Madrid
Hospital Virgen del Rocio
Seville
Fundación Instituto Valenciano de Oncología
Valencia
Germany3 sites
HELIOS Klinikum Berlin-Buch
Berlin
Mannheim University Medical Centre, University of Heidelberg
Mannheim, 68167
Universitätsklinikum München
Munich
Poland1 site
M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology
Warsaw
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Crenolanib in Subjects With Advanced or Metastatic Gastrointestinal Stromal Tumors With a D842V Mutation in the PDGFRA Gene
This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.
- Conditions
- GIST With D842V Mutated PDGFRA Gene
- Being tested
- Crenolanib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrenolanibDrug
Also called Crenolanib Besylate
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Crenolanib Arm | Experimental | Investigational product (crenolanib) Receives: Drug: Crenolanib |
| Placebo Arm | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) will be measured from the date of randomization to the date of the first objective radiological disease progression according to centralized committee assessment using modified RECIST version 1.1 or death.
Measured: 3 years
Secondary outcomes (1)
Overall survival (OS) will be measured from the date of randomization to the date of death from any cause. OS will be estimated using the Kaplan-Meier method.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GIST With D842V Mutated PDGFRA GeneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arog Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Leon Berard, Fox Chase Cancer Center
- Responsible party
- Sponsor
- Investigators
- Jean-Yves Blay, MD, Principal investigator, Centre Leon BerardMargaret von Mehren, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847429
- Sponsor's protocol ID
- ARO-012
- Other IDs
- 2015-000287-34, 2015
- Status last verified
- Jan 2021
- First submitted
- 21 Jul 2016
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Crenolanib in Subjects With Advanced or Metastatic Gastrointestinal Stromal Tumors With a D842V Mutation in the PDGFRA Gene
- ClinicalTrials.gov ID
- NCT02847429
- Acronym / sponsor ID
- ARO-012
- Conditions
- GIST With D842V Mutated PDGFRA Gene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Arog Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre Leon Berard, Fox Chase Cancer Center
- Study start
- Aug 2016
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crenolanib Arm | Experimental | Drug: CrenolanibInvestigational product (crenolanib) |
| Placebo Arm | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
- Measurable disease as per modified RECIST 1.1
- Subjects (male or female) ≥ 18 years of age
- Female subjects with reproductive potential must have negative serum or urine pregnancy test
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Key exclusion criteria (4 listed)
- Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
- Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug's half-life in subject is known) prior to randomization, whichever is shorter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrenolanibAlso: Crenolanib Besylate | Drug | Crenolanib Arm |
| Placebo | Drug | Placebo Arm |
Primary outcome
Progression-free survival (PFS) will be measured from the date of randomization to the date of the first objective radiological disease progression according to centralized committee assessment using modified RECIST version 1.1 or death.
Time frame: 3 years
1 secondary outcome
Overall survival (OS) will be measured from the date of randomization to the date of death from any cause. OS will be estimated using the Kaplan-Meier method.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Yves Blay, MD principal investigator
Centre Leon Berard
Margaret von Mehren, MD principal investigator
Fox Chase Cancer Center
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crenolanib in people with GIST With D842V Mutated PDGFRA Gene, run by Arog Pharmaceuticals, Inc. at 23 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Italy, Spain, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) will be measured from the date of randomization to the date of the first objective radiological disease progression according to centralized committee assessment using modified RECIST version 1.1 or death. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.