Colorectal CancerPhase 2NCT05593328
Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Participants With a Kirsten Rat Sarcoma Virus Gene (KRAS) or Neuroblastoma-RAS (NRAS) Mutation
A Phase 2 study testing Onvansertib, FOLFIRI and Bevacizumab in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Cardiff Oncology at 27 sites in United States.
Trial summary
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastatic Colorectal Cancer
- What is being tested?
- Onvansertib, FOLFIRI and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 27 sitesUnited States
- Study dates
- 17 Mar 2023to 9 Dec 2024
- Phase
- Phase 2
- 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 confirmed metastatic and/or unresectable colorectal cancer (CRC).
- Documentation of a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation in exon 2, 3, or 4 in primary tumor or metastasis, assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
- Age ≥ 18 years.
- Participants with tumors that have progressed on an oxaliplatin/fluoropyrimidine--based regimen with or without bevacizumab.
- Participants must have had systemic therapy within 180 days of the screening visit.
- Participants must have, at any time previously, received oxaliplatin-based chemotherapy with or without bevacizumab (≥ 6 weeks in duration).
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- Participants who received oxaliplatin/fluoropyrimidine-based neoadjuvant, adjuvant, and/or fluoropyrimidine maintenance or adjuvant therapy and have disease recurrence or progression > 6 months from their last dose of oxaliplatin will be required to have received oxaliplatin/fluoropyrimidine-based therapy with or without bevacizumab as first-line treatment for metastatic disease.
- Participants who received an oxaliplatin-based regimen in the first-line setting and discontinued oxaliplatin because of toxicity or who received oxaliplatin for maintenance therapy are eligible as long as progression occurred < 6 months after the last dose of oxaliplatin therapy for advanced metastatic disease. It is recommended that these participants be re-challenged (if feasible) with oxaliplatin/fluoropyrimidine therapy and subsequently progress prior to eligibility. Participants with oxaliplatin-related neuropathy or oxaliplatin infusion-related hypersensitivity that cannot be rechallenged with oxaliplatin are eligible.
- Participants must not have received prior treatment with irinotecan.
- FOLFIRI therapy is appropriate for the participant as determined by the Investigator.
- Imaging computed tomography (CT) or magnetic resonance imaging (MRI) of chest/abdomen/pelvis or other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib. Only participants with measurable disease as defined per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) are eligible for enrollment. CT is the preferred imaging modality, but MRI is also accepted. All subsequent scans must consistently use the same imaging modality for comparison with the Screening scan throughout the study.
- Must have acceptable organ function
- Signed informed consent to provide blood sample(s) for specific correlative assays
Who cannot join
- Concomitant KRAS or NRAS and BRAF-V600 mutation or Microsatellite Instability High/Deficient Mismatch Repair (MSI-H/dMMR).
- Anti-cancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug. The exception is a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before enrollment, provided it is not the target lesion.
- More than 1 prior chemotherapy regimen administered in the metastatic setting.
- Major surgery within 6 weeks prior to enrollment.
- Untreated or symptomatic brain metastasis.
- Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (e.g., intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection).
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- Unable or unwilling to swallow study drug.
- Known hypersensitivity to fluoropyrimidine or leucovorin.
- Known hypersensitivity to irinotecan.
- Abnormal glucuronidation of bilirubin; known Gilbert's syndrome.
- QT interval:
- Fridericia's correction (QTcF) > 470 milliseconds. The QTcF should be calculated as the arithmetic mean of the QTcF on triplicate electrocardiograms (ECGs). In the case of potentially correctible causes of QT prolongation that are readily corrected (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during Screening and that result may be used to determine eligibility.
- Planned concomitant use of medications known to prolong the QT/QTc interval according to institutional guidelines.
- Presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia.
- Use of strong cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19) inhibitors or strong CYP3A4 inducers. Participants currently receiving these agents who can be switched to alternate therapy are not excluded. Inhibitors should be stopped at least 1 week prior to the first dose of protocol therapy and inducers should be stopped at least 2 weeks prior to initiation of protocol therapy.
- The following are exclusion criteria for bevacizumab:
- History of cardiac disease: Congestive heart failure (CHF) Class II or higher according to the New York Heart Association (NYHA); active coronary artery disease, myocardial infarction within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of participants who have been receiving therapy and are deemed by the Investigator to have stable/controlled disease.
- Current uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management) and prior history of hypertensive crisis or hypertensive encephalopathy.
- History of arterial thrombotic or embolic events (within 6 months prior to study entry).
- Significant vascular disease (eg, aortic aneurysm, aortic dissection, symptomatic peripheral vascular disease).
- Evidence of bleeding diathesis or clinically significant coagulopathy.
- Major surgical procedure (including open biopsy, significant traumatic injury, etc) within 28 days, or anticipation of the need for major surgical procedure during the study, and minor surgical procedure (excluding placement of a vascular access device) within 7 days prior to study enrollment.
- Proteinuria at Screening as demonstrated by urinalysis with proteinuria ≥2+ (participants discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤1 g of protein in 24 hours to be eligible).
- Abdominal fistula, gastrointestinal perforation, peptic ulcer, or intra-abdominal abscess within the past 6 months.
- Ongoing serious, non-healing wound, ulcer, or bone fracture
- Known hypersensitivity to any component of bevacizumab
- History of reversible posterior leukoencephalopathy syndrome
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Pacific Cancer Medical Center
Anaheim, California, 92801
Comprehensive Blood and Cancer Center - Bakersfield
Bakersfield, California, 93309
Gabrail Cancer and Research Center
Canton, Ohio, 44718
University of Virginia School of Medicine
Charlottesville, Virginia, 22903
Trihealth Kenwood
Cincinnati, Ohio, 45236
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Englewood Health
Englewood, New Jersey, 07631
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
San Juan Oncology Associates
Farmington, New Mexico, 87401
West Cancer Center - East Campus
Germantown, Tennessee, 38138
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan, 49503
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Central Arkansas Radiation Therapy Institute - Cancer Center
Little Rock, Arkansas, 72205-6523
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Manhattan Hematology Oncology Associates
New York, New York, 10016
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy
Omaha, Nebraska, 68130
UCI Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868
Memorial Hospital West
Pembroke Pines, Florida, 33028
Mayo Clinic in Arizona - Phoenix Campus
Phoenix, Arizona, 85054
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Utah Cancer Specialists
Salt Lake City, Utah, 84106
UCLA Health - Santa Monica Parkside Cancer Care
Santa Monica, California, 90404
Washington University School of Medicine Center for Advanced Medicine
St Louis, Missouri, 63110
Torrance Memorial Physician Network - Cancer Care and Infusion Center
Torrance, California, 90505
PIH Health
Whittier, California, 90602
About this study
Official title: A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
- Conditions
- Colorectal Cancer, Metastatic Colorectal Cancer
- Being tested
- Onvansertib, FOLFIRI, Bevacizumab
- Keywords
- Colorectal Cancer, Metastatic Colorectal Cancer, KRAS Mutation, NRAS Mutation, Onvansertib, FOLFIRI, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnvansertibDrug
Oral capsule
FOLFIRIDrug
FOLFIRI (irinotecan + fluorouracil [5-FU] + leucovorin) as intravenous (IV) infusion
BevacizumabDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Onvansertib 20 mg + Standard of Care (SOC) | Experimental | Participants will receive 20 mg of onvansertib on Days 1 to 5 and 15 to 19 of a 28-day treatment cycle and SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle. Receives: Drug: Onvansertib; Drug: FOLFIRI; Drug: Bevacizumab |
| Onvansertib 30 mg + Standard of Care (SOC) | Experimental | Participants will receive 30 mg of onvansertib on Days 1 to 5 and 15 to 19 of a 28-day treatment cycle and SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle. Receives: Drug: Onvansertib; Drug: FOLFIRI; Drug: Bevacizumab |
| Standard of Care (SOC) | Active comparator | Participants will receive SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle. Receives: Drug: FOLFIRI; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Defined as complete response (CR) or partial response (PR) as determined according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by an independent central review.
Measured: Up to approximately 1 year
Secondary outcomes (14)
Progression-free Survival (PFS)
Defined from the date of first drug administration to progression or death, whichever occurs first.
Measured: Up to approximately 1 year
Number of Participants with an Adverse Event (AE)
Type, incidence, causality and severity of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Clinically significant changes from baseline in vital signs, laboratory parameters, electrocardiograms (ECGs), physical examinations, weight, and Eastern Cooperative Oncology Group (ECOG) performance status will be recorded as AEs.
Measured: Up to approximately 1 year
Disease Control Rate (DCR)
Defined as CR plus PR plus stable disease (SD).
Measured: Up to approximately 1 year
Duration of Response (DOR)
Defined from the date of first response (CR or PR) to disease progression (PD) or death, whichever occurs first.
Measured: Up to approximately 1 year
Overall Survival (OS)
Defined as the time from drug administration to death due to any cause.
Measured: Up to approximately 1 year
Overall Response (OR)
Defined as CR or PR, PFS, DCR, DOR, and OS associated with a reduction in mutation allele frequency (MAF).
Measured: Up to approximately 1 year
Maximum Concentration (Cmax) of Onvansertib
Measured: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Area Under The Plasma Concentration Curve (AUC) of Onvansertib
Measured: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Trough Concentration (Ctrough) of Onvansertib
Measured: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Maximum Concentration (Cmax) of Onvansertib Metabolites
Measured: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Area Under The Plasma Concentration Curve (AUC) of Onvansertib Metabolites
Measured: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Trough Concentration (Ctrough) of Onvansertib Metabolites
Measured: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Efficacy: Exposure Response Evaluation of Onvansertib
Correlation between onvansertib exposure and overall response rate.
Measured: Up to approximately 1 year
Safety: Exposure Response Evaluation of Onvansertib
Correlation between onvansertib exposure and the number of participants with an AE.
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start17 Mar 2023
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593328
- Sponsor's protocol ID
- CRDF-003
- Status last verified
- Jan 2025
- First submitted
- 20 Oct 2022
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation
- ClinicalTrials.gov ID
- NCT05593328
- Acronym / sponsor ID
- CRDF-003
- Conditions
- Colorectal Cancer, Metastatic Colorectal Cancer
- Keywords
- Colorectal Cancer, Metastatic Colorectal Cancer, KRAS Mutation, NRAS Mutation, Onvansertib, FOLFIRI, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cardiff OncologyIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 25 Oct 2022 (actual)
- 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.
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Onvansertib 20 mg + Standard of Care (SOC) | Experimental | Drug: Onvansertib, Drug: FOLFIRI, Drug: BevacizumabParticipants will receive 20 mg of onvansertib on Days 1 to 5 and 15 to 19 of a 28-day treatment cycle and SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle. |
| Onvansertib 30 mg + Standard of Care (SOC) | Experimental | Drug: Onvansertib, Drug: FOLFIRI, Drug: BevacizumabParticipants will receive 30 mg of onvansertib on Days 1 to 5 and 15 to 19 of a 28-day treatment cycle and SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle. |
| Standard of Care (SOC) | Active comparator | Drug: FOLFIRI, Drug: BevacizumabParticipants will receive SOC (FOLFIRI + bevacizumab) on Days 1 and 15 of each 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed metastatic and/or unresectable colorectal cancer (CRC).
- Documentation of a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation in exon 2, 3, or 4 in primary tumor or metastasis, assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
- Age ≥ 18 years.
- Participants with tumors that have progressed on an oxaliplatin/fluoropyrimidine--based regimen with or without bevacizumab.
- Participants must not have received prior treatment with irinotecan.
Key exclusion criteria (27 listed)
- Concomitant KRAS or NRAS and BRAF-V600 mutation or Microsatellite Instability High/Deficient Mismatch Repair (MSI-H/dMMR).
- Anti-cancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug. The exception is a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before enrollment, provided it is not the target lesion.
- More than 1 prior chemotherapy regimen administered in the metastatic setting.
- Major surgery within 6 weeks prior to enrollment.
- Untreated or symptomatic brain metastasis.
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 |
|---|---|---|
| OnvansertibOral capsule | Drug | Onvansertib 20 mg + Standard of Care (SOC), Onvansertib 30 mg + Standard of Care (SOC) |
| FOLFIRIFOLFIRI (irinotecan + fluorouracil [5-FU] + leucovorin) as intravenous (IV) infusion | Drug | Onvansertib 20 mg + Standard of Care (SOC), Onvansertib 30 mg + Standard of Care (SOC), Standard of Care (SOC) |
| BevacizumabIV infusion | Drug | Onvansertib 20 mg + Standard of Care (SOC), Onvansertib 30 mg + Standard of Care (SOC), Standard of Care (SOC) |
Primary outcome
Overall Response Rate
Time frame: Up to approximately 1 year
Defined as complete response (CR) or partial response (PR) as determined according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by an independent central review.
14 secondary outcomes
Progression-free Survival (PFS)
Time frame: Up to approximately 1 year
Number of Participants with an Adverse Event (AE)
Time frame: Up to approximately 1 year
Disease Control Rate (DCR)
Time frame: Up to approximately 1 year
Duration of Response (DOR)
Time frame: Up to approximately 1 year
Overall Survival (OS)
Time frame: Up to approximately 1 year
Overall Response (OR)
Time frame: Up to approximately 1 year
Maximum Concentration (Cmax) of Onvansertib
Time frame: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Area Under The Plasma Concentration Curve (AUC) of Onvansertib
Time frame: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Trough Concentration (Ctrough) of Onvansertib
Time frame: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Maximum Concentration (Cmax) of Onvansertib Metabolites
Time frame: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Area Under The Plasma Concentration Curve (AUC) of Onvansertib Metabolites
Time frame: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Trough Concentration (Ctrough) of Onvansertib Metabolites
Time frame: Day 1 and Day 5 of Cycle 1, and Day 5 of Cycle 3 (cycle is 28 days)
Efficacy: Exposure Response Evaluation of Onvansertib
Time frame: Up to approximately 1 year
Safety: Exposure Response Evaluation of Onvansertib
Time frame: Up to approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- 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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Onvansertib, FOLFIRI and Bevacizumab in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Cardiff Oncology at 27 sites in United States.
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 13 inclusion and 27 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Response Rate (time frame: Up to approximately 1 year). 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 10 Jan 2025.