Gastrointestinal Stromal TumorsPhase 3INVICTUSNCT03353753
Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies
A Phase 3 study testing DCC-2618 in people with Gastrointestinal Stromal Tumors, run by Deciphera Pharmaceuticals, LLC at 35 sites in 13 countries.
Trial summary
This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- DCC-2618
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 35 sitesin 13 countries
- Study dates
- 27 Feb 2018to 11 May 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologic diagnosis of GIST
- Patients must have progressed on imatinib, sunitinib, and regorafenib or have documented intolerance to any of these treatments.
- ECOG PS of 0 to 2 at screening.
- Able to provide an archival tumor tissue sample if no anticancer therapy was administered since the sample was collected; otherwise, a fresh tumor tissue sample is required prior to the first dose of study drug.
- Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotrophin (β-hCG) pregnancy test at screening and negative urine pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
- Patients of reproductive potential must agree to follow the contraception requirements.
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- The patient is capable of understanding and complying with the protocol and has signed the informed consent document. A signed informed consent form must be obtained before any study-specific procedures are performed.
- At least 1 measurable lesion according to modified RECIST Version 1.1 (non-nodal lesions must be ≥1.0 cm in the long axis or ≥double the slide thickness in the long axis) within 21 days prior to the first dose of study drug.
- Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments performed at screening.
- Absolute neutrophil count ≥1000/uL
- Hemoglobin ≥8 g/dL
- Platelet count ≥75,000/uL
- Total bilirubin ≤1.5 x the upper limit of normal (ULN)
- Aspartate transaminase or alanine transaminase ≤3 x ULN (≤5x ULN in the presence of hepatic metastases)
- Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min based on either urine collection or Cockcroft Gault estimation.
- Prothrombin time (PT) or international normalized ratio (INR) or partial thromboplastin time ≤1.5 x ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to study drug administration may have PT/INR measurements >1.5 x ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to randomization.
- Resolution of all toxicities from prior therapy to ≤Grade 1 (or baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).
Who cannot join
- Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug. For prior biological therapies, eg, monoclonal antibodies with a half-life longer than 3 days, the interval must be at least 28 days prior to the first dose of study drug.
- Prior treatment with DCC-2618
- Prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of DCC-2618. Patients receiving adjuvant cancer treatment are not eligible if those medications are potentially active against GIST or excluded per protocol.
- Patient has known active central nervous system metastases.
- New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
- Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
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- Venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) within 3 months before the first dose of study drug. Patients with venous thrombotic events ≥3 months before the first dose of study drug on stable anticoagulation therapy are eligible.
- 12-lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula >450 ms in males or >470 ms in females at screening or history of long QT interval corrected syndrome.
- Left ventricular ejection fraction (LVEF) <50% at screening.
- Use of proton-pump inhibitors within 4 days prior to the first dose of study drug. Other medications that increase gastric pH, ie, histamine H2 receptor antagonists and antacids may be taken provided they are not administered within 2 hours before or after administration of study drug.
- Use of strong or moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4, including certain herbal medications (eg, St. John's Wort) and consumption of grapefruit or grapefruit juice within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
- Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug. Following major surgeries, >4 weeks prior to the first dose of study drug, all surgical wounds must be healed and free of infection or dehiscence.
- Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
- Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, active hepatitis B, or active hepatitis C infection.
- If female, the patient is pregnant or lactating.
- Known allergy or hypersensitivity to any component of the investigational drug product. Patients with a history of Stevens-Johnson syndrome on a prior TKI are excluded.
- Gastrointestinal abnormalities including but not limited to:
- inability to take oral medication
- malabsorption syndromes
- requirement for intravenous alimentation
- Any active bleeding excluding hemorrhoidal or gum bleeding.
Trial locations and contacts
35 sites in 13 countries.
35 sites in 13 countries
United States15 sites
Georgia Cancer Specialists
Atlanta, Georgia, 30341
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
University of Southern California - Norris
Los Angeles, California, 90033
UCLA
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia
New York, New York, 10027
MSKCC
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
HonorHealth
Scottsdale, Arizona, 85260
Stanford
Stanford, California, 94305
France3 sites
Institut Bergonié
Bordeaux
Le Centre Léon Bérard
Lyon
Gustave-Roussy
Villejuif
Germany3 sites
Sarcoma Center Brandenburg
Brandenburg
University Hospital Essen
Essen
Universitätsmedizin Mannheim
Mannheim
Canada2 sites
Cross Cancer Center
Edmonton, Alberta
Princess Margaret Hospital
Toronto
Italy2 sites
Istituto Nazionale dei Tumori
Milan
Università Campus Bio-Medico di Roma
Rome
Spain2 sites
Vall d'Hebron
Barcelona
Hospitalario Universitario Virgen del Rocío
Seville
United Kingdom2 sites
Royal Marsden
London
University of Sheffield
Sheffield
About this study
Official title: A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies
This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- DCC-2618, Placebo Oral Tablet
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCC-2618Drug
Also called ripretinib
Oral KIT/PDGFRA kinase inhibitor
Placebo Oral TabletDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 150 mg QD DCC-2618 Receives: Drug: DCC-2618 |
| Arm 2 | Placebo comparator | Placebo Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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.
Measured: 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)].
Secondary outcomes (6)
Objective Response Rate (ORR)
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.
Measured: 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)].
Time to Tumor Progression (TTP) Based on Independent Radiologic Review
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.
Measured: From date of randomization to the earliest date of disease progression [through database cutoff 31-May-2019 (up to approximately 15 months)].
Overall Survival (OS)
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.
Measured: From the date of randomization to the date of death from any cause [through database cutoff 31-May-2019 (up to approximately 15 months)].
Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning
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.
Measured: From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Quality of Life & Disease-Related Symptoms - Physical Functioning
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.
Measured: From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale
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.
Measured: From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start27 Feb 2018
- Primary completion31 May 2019
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by Deciphera Pharmaceuticals, LLCThe sponsor's other registered studies.
- 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353753
- Sponsor's protocol ID
- DCC-2618-03-001
- Acronym
- INVICTUS
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2017
- Last updated
- 21 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schoffski P, George S, Heinrich MC, Zalcberg JR, Bauer S, Gelderblom H, Serrano C, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Becker C, Shi K, Meade J, Ruiz-Soto R, Blay JY, von Mehren M. Patient-reported outcomes in individuals with advanced gastrointestinal stromal tumor treated with ripretinib in the fourth-line setting: analysis from the phase 3 INVICTUS trial. BMC Cancer. 2022 Dec 13;22(1):1302. doi: 10.1186/s12885-022-10379-9.
PubMed 36514034Symcox M, Somaiah N. Ripretinib for advanced gastrointestinal stromal tumor: Plain language summary of the INVICTUS study. Future Oncol. 2021 Dec 1;17(36):5007-5012. doi: 10.2217/fon-2021-0803. Epub 2021 Oct 18.
PubMed 34661454Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schoffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. doi: 10.1016/S1470-2045(20)30168-6. Epub 2020 Jun 5.
PubMed 32511981
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies
- ClinicalTrials.gov ID
- NCT03353753
- Acronym / sponsor ID
- INVICTUS / DCC-2618-03-001
- Conditions
- Gastrointestinal Stromal Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Posted 23 Apr 2021
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 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo
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 |
|---|---|---|
| Arm 1 | Active comparator | Drug: DCC-2618150 mg QD DCC-2618 |
| Arm 2 | Placebo comparator | Drug: Placebo Oral TabletPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologic diagnosis of GIST
- Patients must have progressed on imatinib, sunitinib, and regorafenib or have documented intolerance to any of these treatments.
- ECOG PS of 0 to 2 at screening.
- Able to provide an archival tumor tissue sample if no anticancer therapy was administered since the sample was collected; otherwise, a fresh tumor tissue sample is required prior to the first dose of study drug.
- Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotrophin (β-hCG) pregnancy test at screening and negative urine pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
Key exclusion criteria (22 listed)
- Treatment with anticancer therapy, including investigational therapy, or investigational procedures within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug. For prior biological therapies, eg, monoclonal antibodies with a half-life longer than 3 days, the interval must be at least 28 days prior to the first dose of study drug.
- Prior treatment with DCC-2618
- Prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of DCC-2618. Patients receiving adjuvant cancer treatment are not eligible if those medications are potentially active against GIST or excluded per protocol.
- Patient has known active central nervous system metastases.
- New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
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 |
|---|---|---|
| DCC-2618Also: ripretinibOral KIT/PDGFRA kinase inhibitor | Drug | Arm 1 |
| Placebo Oral TabletPlacebo | Drug | Arm 2 |
Primary outcome
Progression-Free Survival (PFS)
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)].
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.
6 secondary outcomes
Objective Response Rate (ORR)
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)].
Time to Tumor Progression (TTP) Based on 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)].
Overall Survival (OS)
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)].
Quality of Life & Disease-Related Symptoms - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30-Item - Role Functioning
Time frame: From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Quality of Life & Disease-Related Symptoms - Physical Functioning
Time frame: From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale
Time frame: From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36514034Schoffski P, George S, Heinrich MC, Zalcberg JR, Bauer S, Gelderblom H, Serrano C, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Becker C, Shi K, Meade J, Ruiz-Soto R, Blay JY, von Mehren M. Patient-reported outcomes in individuals with advanced gastrointestinal stromal tumor treated with ripretinib in the fourth-line setting: analysis from the phase 3 INVICTUS trial. BMC Cancer. 2022 Dec 13;22(1):1302. doi: 10.1186/s12885-022-10379-9.
- Derived from this study: PubMed 34661454Symcox M, Somaiah N. Ripretinib for advanced gastrointestinal stromal tumor: Plain language summary of the INVICTUS study. Future Oncol. 2021 Dec 1;17(36):5007-5012. doi: 10.2217/fon-2021-0803. Epub 2021 Oct 18.
- Derived from this study: PubMed 32511981Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schoffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. doi: 10.1016/S1470-2045(20)30168-6. Epub 2020 Jun 5.
- Deciphera Company WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DCC-2618 in people with Gastrointestinal Stromal Tumors, run by Deciphera Pharmaceuticals, LLC at 35 sites in 13 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 17 inclusion and 22 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: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, France, Germany, Canada, Italy and 8 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?
Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) (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)].). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353753, which also lists 3 linked publications.
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 21 Nov 2022.