Myelodysplastic Syndromes (MDS)Phase 1/2NCT03593915
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
A Phase 1/2 study testing Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine in people with Myelodysplastic Syndromes (MDS), run by Sumitomo Pharma America, Inc. at 12 sites in United States.
Trial summary
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS. Patients with IPSS-R intermediate and above MDS have an increased risk of developing AML and may be treated with the same chemotherapy regimens used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes (MDS)
- What is being tested?
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 12 sitesUnited States
- Study dates
- 29 Aug 2018to 16 Aug 2021
- Phase
- Phase 1/2
- 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
- Aged ≥18 years
- Phase 1b Dose Escalation: Patients with previously untreated MDS and patients with MDS who received fewer than six (6) cycles of previous HMAs. Phase 1b Expansion: Untreated patients with de novo or secondary MDS. Phase 2: Untreated patients with de novo or secondary MDS
- Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score ≤2 at enrollment
- Provide written informed consent prior to any study-related procedure. (In the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.)
- Patients with a life expectancy of ≥3 months (90 days)
- Patients with adequate major organ functions meeting the following criteria on the basis of laboratory data within 4 weeks (28 days) before enrollment (if multiple data are available, most recent data during the period):
Show all 12Show fewer
- Serum creatinine: ≤1.8× the upper limit of the normal (ULN) range
- Total bilirubin: ≤2× the ULN
- Aspartate transaminase (AST) and alanine transaminase (ALT): ≤3× the ULN
- Left ventricular ejection fraction (LVEF) >45% by echocardiogram or multigated acquisition (MUGA) scan
- Be able to comply with the requirements of the entire study.
- Patients with Revised International Prognostic Scoring System (IPSS-R) intermediate-, high-, and very high-risk MDS
Who cannot join
- Presence of concomitant severe cardiovascular disease:
- Patients who had myocardial infarction within 6 months (180 days) before enrollment
- Patients with significant diseases at enrollment that may affect study treatment, such as New York Heart Association (NYHA) Functional Class III or IV heart disease, National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≥3 arrhythmia, angina pectoris, abnormal electrocardiogram findings, interstitial pneumonia or pulmonary fibrosis
- Presence of concomitant malignancy requiring chemotherapy or any malignancy (except basal and squamous cell carcinoma of the skin) for which the patient received chemotherapy within 6 months prior to enrollment. NOTE: Diagnosis of any previous or concomitant malignancy is thus not an exclusion criterion.
- Presence of uncontrolled or uncontrollable infection(s); or ≥Grade 3 infection according to NCI CTCAE v5.0
- Presence of any psychological, familial, sociological or geographical condition that, in the opinion of the investigator, could potentially hinder compliance with the study protocol and follow-up schedule
Show all 17Show fewer
- Patients with a dry tap on bone marrow aspiration before enrollment
- Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, or patients who require long-term systemic steroid therapy greater than the equivalent of 20 mg of prednisone daily (excluding therapy given on an 'as needed' [PRN] basis)
- Patients with other documented malignancies within past year aside from synchronous or metachronous multiple cancers with a disease-free period of ≤5 years (excluding carcinoma in situ, mucosal carcinoma, or other such carcinomas curatively treated with local therapy)
- Patients with ≥Grade 2 hemorrhage according to NCI CTCAE v5.0
- Patients who have previously received alvocidib or another cyclin-dependent kinase 9 (CDK9) inhibitor
- Patients who are pregnant or breastfeeding
- Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception associated with a low failure rate prior to study entry, for the duration of study participation and for at least 6 months after the last dose of study drug. (Patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy, or bilateral tubal ligation / salphingectomy, or postmenopausal for at least 2 years.)
- Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception during the trial and for at least 3 months after the last administration of study treatment.
- Patients who are inappropriate for participation in the study for other reasons in the opinion of the investigator or sub-investigator(s)
- Patients with a known hypersensitivity to decitabine (those patients enrolled in escalation) or azacitidine or mannitol
- Patients who have received erythropoietin-stimulating agents (ESAs) within 2 weeks (14 days) prior to Cycle 1/Day 1
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
US Oncology - Texas Oncology - Austin Midtown
Austin, Texas, 78705
Johns Hopkins
Baltimore, Maryland, 21218
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Chicago
Chicago, Illinois, 60637
US Oncology - Texas Oncology - Baylor University Medical Center
Dallas, Texas, 75246
US Oncology - Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
US Oncology - Texas Oncology - Fort Worth
Fort Worth, Texas, 76104
University of Iowa
Iowa City, Iowa, 52242
Columbia University
New York, New York, 10032
US Oncology - Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78240
US Oncology - Texas Oncology - Tyler
Tyler, Texas, 75702
US Oncology - Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
About this study
Official title: A Phase 1b/2, Open-label Clinical Study to Determine Preliminary Safety and Efficacy of Alvocidib When Administered in Sequence After Decitabine or Azacitidine in Patients With MDS
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS. Patients with IPSS-R intermediate and above MDS have an increased risk of developing AML and may be treated with the same chemotherapy regimens used in patients with AML. Eight Phase I or II clinical trials have been completed in patients with AML, totaling more than 400 patients with both relapsed/refractory or newly diagnosed AML.
Preclinical studies have demonstrated that decitabine exposure increased the expression of NOXA, which is a specific antagonist of the survival factor MCL 1. Pharmacologic downregulation of MCL-1 via CDK 9 inhibition, as well as upregulation of the MCL-1 antagonist, NOXA, following decitabine exposure may result in enhanced antileukemic activity in MCL-1-dependent malignancies.
Read the detailed description
PHASE 1b:
Patients will be enrolled in cohorts of 3-6 patients. Escalation of the alvocidib dose will follow a standard 3+3 design with sequential cohorts of 3 patients treated with incrementally higher doses of alvocidib administered in sequence after decitabine (during dose escalation) or azacitidine until a dose-limiting toxicity (DLT) is observed and the MTD is established.
Once the MTD or preliminary RP2D of alvocidib administered via hybrid dosing is identified, 2 cohorts of at least 3 patients each will receive azacitadine followed by alvocidib administered as a 30-60 minute IV infusion.
Expansion at MTD Once the MTD or preliminary RP2D of alvocidib administered as a 30-to-60 minute IV infusion is determined, up to 25 patients will be enrolled in an Expansion cohort to receive alvocidib following azacitadine to confirm safety, explore potential biomarkers, and evaluate potential signals of alvocidib activity. Once this Expansion cohort is completed, the study will progress to Phase 2
PHASE 2:
Phase 2 design is based on the Simon 2-stage minimax design (Simon 1989).
- Stage 1: Up to 15 evaluable patients will be enrolled and treated at the RP2D identified in the Phase 1b study.
- Stage 2: Ten patients will be enrolled to bring the total enrollment in Phase 2 (including Stage-1 patients) to 25 evaluable patients. Stage-2 patients will also receive the RP2D dose of alvocidib administered by 30-to-60 minute IV infusion identified in the Phase 1b study. If 6 or more responses are observed in 25 patients, the conclusion will be that the combination regimen is worthy of further investigation.
- Conditions
- Myelodysplastic Syndromes (MDS)
- Being tested
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- Keywords
- Previously untreated MDS, MDS who have received <6 cycles of treatment with hypomethylating agents (HMAs), De novo or secondary MDS (treatment-related) who are not eligible for intensive induction chemotherapy or stem cell transplant, FAB subtypes: refractory anemia [RA], RA w/ ringed sideroblasts, RA w/ excess blasts, RA w/ excess blasts in transformation or chronic myelomonocytic leukemia, Intermediate and above per the Revised International Prognostic Scoring System (IPSS-R) groups, Sumitomo Oncology SMPO, Cancer, Phase 1b/2
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alvocidib Plus Decitabine (during dose escalation only) or AzacitidineCombination product
PHASE 1b:
Decitabine administered as an intravenous (IV) infusion daily for 5 days at a dose of 20 mg/m2 followed on Day 8 by alvocidib as a loading dose over 30 minutes followed by a 4-hour IV infusion (hybrid dosing) Once the maximum dose of alvocidib administered via hybrid dosing has been determined, 2 cohorts of patients will receive azacitidine followed by alvocidib administered as an IV infusion. Azacitidine may be administered as either an IV bolus over 10 to 40 minutes or as a subcutaneous (SC) injection on either a 7 day or 5-2 2 schedule. Regardless of which azacitidine schedule or route of administration is used, alvocidib will be given on Day 10 as a 30-to-60 minute IVI
PHASE 2:
The Phase 2 study will use the RP2D from the Phase 1b study and follow a Simon 2-stage minimax design using the RP2D of alvocidib administered as a 30-to-60 minute IV infusion determined in the Ph1b study to explore efficacy of alvocidib when administered in sequence after azacitidine.
| Study group | Role | What they receive |
|---|---|---|
| Ph 1b and 2: MDS | Experimental | * Patients with previously untreated MDS
* Patients with MDS who have received <6 cycles of HMAs (during dose escalation only)
* Patients with de novo (cause unknown) or secondary MDS (treatment-related) who are not eligible for intensive induction chemotherapy or stem cell transplant
* All French-American-British (FAB) subtypes
* Intermediate and above per IPSS-R groups Receives: Combination Product: Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events and Serious Adverse Events
Assessment of safety of alvocidib administered in combination with either decitabine (DEC) or azacitidine (AZA) by reporting of adverse events and serious adverse events
Measured: From the time of first dose to 30 days after the last dose, an average of 33.7 weeks.
Tolerability of Alvocidib as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) as Observed in Cycle 1
The DLTs are defined as follows based on the NCI CTCAE v5.0: Must be at least possibly related to Alvocidib; Any Gr 4 nonhematologic toxicity; Gr 3 nonhematologic toxicity that does not resolve to ≤Gr 2 in 48 hours; Gr 3 diarrhea, mucositis, nausea, or vomiting will be considered dose limiting only if resolution to ≤Gr 2 requires >7 days; and ≥Grade 3 creatinine elevation that does not resolve to <G2 within 7 days.
Measured: Cycle 1 (28 days)
Secondary outcomes (2)
Determination of the Complete Response Rate
The calculation for Complete Response Rate is as follows: complete response [CR] / complete response with incomplete blood count recovery [CRi] / CRmarrow / partial response [PR] / hematologic improvement [HI]
Measured: From the date of first treatment, every 8 weeks, for the first 6 cycles, for an average of 26 weeks
Improvement in Transfusion Dependence
Determine if treatment with alvocidib administered in sequence after DEC or AZA resulted in improvements in transfusion dependence
Measured: Duration of study treatment up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start29 Aug 2018
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Why it stopped: The sponsor decided not to continue the study based on the overall company strategy in AML.
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.
- Other trials for Myelodysplastic Syndromes (MDS)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Anthony, DO, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593915
- Sponsor's protocol ID
- TPI-ALV-102
- Status last verified
- Nov 2023
- First submitted
- 24 May 2018
- Last updated
- 9 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open-label Clinical Study to Determine Preliminary Safety and Efficacy of Alvocidib When Administered in Sequence After Decitabine or Azacitidine in Patients With MDS
- ClinicalTrials.gov ID
- NCT03593915
- Acronym / sponsor ID
- TPI-ALV-102
- Conditions
- Myelodysplastic Syndromes (MDS)
- Keywords
- Previously untreated MDS, MDS who have received <6 cycles of treatment with hypomethylating agents (HMAs), De novo or secondary MDS (treatment-related) who are not eligible for intensive induction chemotherapy or stem cell transplant, FAB subtypes: refractory anemia [RA], RA w/ ringed sideroblasts, RA w/ excess blasts, RA w/ excess blasts in transformation or chronic myelomonocytic leukemia, Intermediate and above per the Revised International Prognostic Scoring System (IPSS-R) groups, Sumitomo Oncology SMPO, Cancer, Phase 1b/2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided not to continue the study based on the overall company strategy in AML.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 21 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS. Patients with IPSS-R intermediate and above MDS have an increased risk of developing AML and may be treated with the same chemotherapy regimens used in patients with AML. Eight Phase I or II clinical trials have been completed in patients with AML, totaling more than 400 patients with both relapsed/refractory or newly diagnosed AML.
Preclinical studies have demonstrated that decitabine exposure increased the expression of NOXA, which is a specific antagonist of the survival factor MCL 1. Pharmacologic downregulation of MCL-1 via CDK 9 inhibition, as well as upregulation of the MCL-1 antagonist, NOXA, following decitabine exposure may result in enhanced antileukemic activity in MCL-1-dependent malignancies.
Detailed description
PHASE 1b:
Patients will be enrolled in cohorts of 3-6 patients. Escalation of the alvocidib dose will follow a standard 3+3 design with sequential cohorts of 3 patients treated with incrementally higher doses of alvocidib administered in sequence after decitabine (during dose escalation) or azacitidine until a dose-limiting toxicity (DLT) is observed and the MTD is established.
Once the MTD or preliminary RP2D of alvocidib administered via hybrid dosing is identified, 2 cohorts of at least 3 patients each will receive azacitadine followed by alvocidib administered as a 30-60 minute IV infusion.
Expansion at MTD Once the MTD or preliminary RP2D of alvocidib administered as a 30-to-60 minute IV infusion is determined, up to 25 patients will be enrolled in an Expansion cohort to receive alvocidib following azacitadine to confirm safety, explore potential biomarkers, and evaluate potential signals of alvocidib activity. Once this Expansion cohort is completed, the study will progress to Phase 2
PHASE 2:
Phase 2 design is based on the Simon 2-stage minimax design (Simon 1989).
- Stage 1: Up to 15 evaluable patients will be enrolled and treated at the RP2D identified in the Phase 1b study.
- Stage 2: Ten patients will be enrolled to bring the total enrollment in Phase 2 (including Stage-1 patients) to 25 evaluable patients. Stage-2 patients will also receive the RP2D dose of alvocidib administered by 30-to-60 minute IV infusion identified in the Phase 1b study. If 6 or more responses are observed in 25 patients, the conclusion will be that the combination regimen is worthy of further investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ph 1b and 2: MDS | Experimental | Combination Product: Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine* Patients with previously untreated MDS * Patients with MDS who have received <6 cycles of HMAs (during dose escalation only) * Patients with de novo (cause unknown) or secondary MDS (treatment-related) who are not eligible for intensive induction chemotherapy or stem cell transplant * All French-American-British (FAB) subtypes * Intermediate and above per IPSS-R groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged ≥18 years
- Phase 1b Dose Escalation: Patients with previously untreated MDS and patients with MDS who received fewer than six (6) cycles of previous HMAs. Phase 1b Expansion: Untreated patients with de novo or secondary MDS. Phase 2: Untreated patients with de novo or secondary MDS
- Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score ≤2 at enrollment
- Provide written informed consent prior to any study-related procedure. (In the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.)
- Patients with a life expectancy of ≥3 months (90 days)
Key exclusion criteria (17 listed)
- Presence of concomitant severe cardiovascular disease:
- Presence of concomitant malignancy requiring chemotherapy or any malignancy (except basal and squamous cell carcinoma of the skin) for which the patient received chemotherapy within 6 months prior to enrollment. NOTE: Diagnosis of any previous or concomitant malignancy is thus not an exclusion criterion.
- Presence of uncontrolled or uncontrollable infection(s); or ≥Grade 3 infection according to NCI CTCAE v5.0
- Presence of any psychological, familial, sociological or geographical condition that, in the opinion of the investigator, could potentially hinder compliance with the study protocol and follow-up schedule
- Patients with a dry tap on bone marrow aspiration before enrollment
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 |
|---|---|---|
| Alvocidib Plus Decitabine (during dose escalation only) or AzacitidinePHASE 1b: Decitabine administered as an intravenous (IV) infusion daily for 5 days at a dose of 20 mg/m2 followed on Day 8 by alvocidib as a loading dose over 30 minutes followed by a 4-hour IV infusion (hybrid dosing) Once the maximum dose of alvocidib administered via hybrid dosing has been determined, 2 cohorts of patients will receive azacitidine followed by alvocidib administered as an IV infusion. Azacitidine may be administered as either an IV bolus over 10 to 40 minutes or as a subcutaneous (SC) injection on either a 7 day or 5-2 2 schedule. Regardless of which azacitidine schedule or route of administration is used, alvocidib will be given on Day 10 as a 30-to-60 minute IVI PHASE 2: The Phase 2 study will use the RP2D from the Phase 1b study and follow a Simon 2-stage minimax design using the RP2D of alvocidib administered as a 30-to-60 minute IV infusion determined in the Ph1b study to explore efficacy of alvocidib when administered in sequence after azacitidine. | Combination product | Ph 1b and 2: MDS |
Primary outcome
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: From the time of first dose to 30 days after the last dose, an average of 33.7 weeks.
Assessment of safety of alvocidib administered in combination with either decitabine (DEC) or azacitidine (AZA) by reporting of adverse events and serious adverse events
Tolerability of Alvocidib as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) as Observed in Cycle 1
Time frame: Cycle 1 (28 days)
The DLTs are defined as follows based on the NCI CTCAE v5.0: Must be at least possibly related to Alvocidib; Any Gr 4 nonhematologic toxicity; Gr 3 nonhematologic toxicity that does not resolve to ≤Gr 2 in 48 hours; Gr 3 diarrhea, mucositis, nausea, or vomiting will be considered dose limiting only if resolution to ≤Gr 2 requires >7 days; and ≥Grade 3 creatinine elevation that does not resolve to <G2 within 7 days.
2 secondary outcomes
Determination of the Complete Response Rate
Time frame: From the date of first treatment, every 8 weeks, for the first 6 cycles, for an average of 26 weeks
Improvement in Transfusion Dependence
Time frame: Duration of study treatment up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Stephen Anthony, DO study director
Sumitomo Pharma America, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine in people with Myelodysplastic Syndromes (MDS), run by Sumitomo Pharma America, Inc. at 12 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 12 inclusion and 17 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: stopped early, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 21 Oct 2022). 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?
Number of Participants With Adverse Events and Serious Adverse Events (time frame: From the time of first dose to 30 days after the last dose, an average of 33.7 weeks.). The study lists 2 primary outcomes in all. 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 9 Nov 2023.