Prevention of Chemotherapy-induced MyelosuppressionPhase 1NCT05622058
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
A Phase 1 study testing ALRN-6924 and TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2) in people with Prevention of Chemotherapy-induced Myelosuppression, run by Aileron Therapeutics, Inc. at 14 sites in 4 countries.
Trial summary
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Chemotherapy-induced Myelosuppression
- What is being tested?
- ALRN-6924 and TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 9 Jan 2023to 22 Feb 2023
- Phase
- Phase 1
- 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
- Females and males, age ≥18years.
- Patients who, in the investigator's judgment, are able to understand and willing to comply with the requirements of this clinical trial and to provide written informed consent.
- Histologically confirmed diagnosis of HER2 negative breast cancer
- Candidate to receive chemotherapy with TAC regimen
- Presence of p53 mutation(s) in tumor tissue as assessed by next generation sequencing (NGS).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2
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- Left ventricular ejection fraction > 55%.
- Laboratory results obtained within 14 days prior to the first study treatment administration (Cycle 1, Day 0) demonstrating:
- Absolute neutrophil count (ANC) ≥ 1500 cells/μL (without granulocyte colony stimulating factor [G-CSF] support within 2 weeks prior to the first study treatment administration)
- Platelet count ≥ 100,000/μL (without transfusion within 2 weeks prior to the first study treatment administration)
- Hemoglobin ≥ 10.0 g/dL
- AST, ALT, and alkaline phosphatase ≤ 2.5 x the upper limit of normal (ULN)
- Serum bilirubin ≤ 1.5× ULN (patients with known Gilbert's disease who have serum bilirubin level ≤ 3× ULN may be enrolled.)
- Patients who are not receiving therapeutic anticoagulation: Calculated creatinine clearance (CrCl) ≥ 30 mL/min (Cockcroft-Gault formula).
- Have not received prior chemotherapy or targeted systemic therapy for their breast cancer.
Who cannot join
- Known hypersensitivity to any component of study treatment.
- Prior chemotherapy for HER2 negative breast cancer.
- 1. Presence of distant metastases. Nodal involvement is acceptable.
- Uncontrolled intercurrent illness including but not limited to:
- Clinically significant, active, uncontrolled infection including human immunodeficiency virus (HIV), or hepatitis B or C
- Patients with HIV must be on effective antiretroviral therapy for ≥ 4 weeks prior to enrollment and have HIV viral load < 400 copies/mL, have had no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the past 12 months, and have CD4+ count ≥ 350 cells/μL.
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- Patients with chronic hepatitis B virus (HBV) must be on antiviral therapy and have HBV viral load below the limits of detection.
- Patients with hepatitis C virus (HCV) must be on or have completed antiviral therapy and have an HCV viral load below the limits of detection.
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker.
- Pregnant or lactating women.
- Hereditary angioedema of any severity or severe or life-threatening angioedema due to any cause.
- Treatment with an investigational agent for any indication within the shorter of 14 days or 5 half-lives, if the half-life is known.
- The required use of any concomitant medications that are predominantly cleared by hepatobiliary transporters, OATP members OATP1B1 and OATP1B3, on the day of the first ALRN-6924 infusion to within 48 hours after the last ALRN-6924 infusion in a treatment cycle. This criterion does not apply to the patients in the control group.
- Other medications, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Clinically evident alopecia of any grade at screening.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States5 sites
Gabrail Cancer Center
Canton, Ohio, 44718
Pennsylvania Cancer Specialists & Resesrach Institute
Gettysburg, Pennsylvania, 17325
Southern Oncology Specialists
Huntersville, North Carolina, 28078
Oncology and Hematology Associates of West Broward
Tamarac, Florida, 33321
Regional Medical Oncolgy Center
Wilson, North Carolina, 27893
Bosnia and Herzegovina4 sites
University Clinical Center of the Republic of Srpska
Banja Luka, 71000
University Clinical Hospital Mostar
Mostar, 88000
Clinical Center University of Sarajevo, Oncology Clinic
Sarajevo, 71000
University Clinical Center Tuzla
Tuzla, 75000
Serbia3 sites
Kliničko bolnički centar "Bežanijska kosa"
Belgrade, 11070
Oncology Institute of Vojvodina
Kamenitz, 21204
Univerzitetski Klinički centar Kragujevac
Kragujevac, 34000
Bulgaria2 sites
MBAL University Hospital OOD
Panagyurishte, 4500
KOC (Complex Oncology Center) Plovdiv
Plovdiv, 4000
About this study
Official title: A Phase 1b Clinical Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, as a Chemoprotection Agent in Patients With TP53-Mutated, HER2 Negative Breast Cancer Receiving Neoadjuvant or Adjuvant Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Chemotherapy affects cells that are dividing, whether they are tumor cells or healthy cells (including, bone marrow cells, hair follicle cells, and epithelial cells lining the gastrointestinal tract). ALRN-6924 is designed to stop cell division in healthy cells but not in tumor cells because they have a mutation of the TP53 gene. When this happens, tumor cells will still be destroyed by the chemotherapy but healthy cells that are not dividing may be spared from chemotherapy damage and the patient should have less side effects.
Read the detailed description
This is a Phase 1b, open-label, single-arm, multicenter clinical trial for evaluation of safety, tolerability and chemoprotection effects of ALRN-6924 combined with chemotherapy in patients with TP53-mutated, HER2 negative breast cancer without distant organ metastases. All patients will receive the neoadjuvant or adjuvant chemotherapy regimen known as TAC. TAC consists of doxorubicin 50 mg/m2 IV infusion, docetaxel 75mg/m2 IV infusion and cyclophosphamide 500 mg/m2 IV infusion, given on Day 1 of every 3-week cycle for a total of 4-6 treatment cycles according to each patient's individual needs, individual institutional policies and standards of care, as well as investigator discretion. ALRN-6924 1.2 mg/kg will be administered on 3 consecutive days in each treatment cycle, Days 0-2. Prophylactic administration of G-CSF prior to the first instance of Grade 4 neutropenia is not allowed in Cycle 1. Myeloid growth factor support with filgrastim should be administered immediately if a patient is diagnosed with Grade 4 neutropenia.
- Being tested
- ALRN-6924, TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
- Keywords
- ALRN-6924, Chemoprotection, Myelosuppression, Cell cycle arrest, p53 mutation, Breast cancer, Alopecia, Neutropenia
- Medical subject headings
- Breast Neoplasms, Alopecia, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALRN-6924Drug
ALRN-6924 administered in every chemotherapy treatment cycle as an IV infusion over 1 hour on Days 0 (approximately 18 hours prior to chemotherapy administration), 1 (approximately 1 hour prior to chemotherapy administration), and 2 (approximately 24 hours after the second infusion of ALRN-6924).
TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)Drug
TAC will be administered as an IV infusion on Day 1 of every 3-week treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| ALRN-6924 Dose plus TAC | Experimental | ALRN-6924 plus Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) Receives: Drug: ALRN-6924; Drug: TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ALRN-6924 in combination with TAC chemotherapy
Proportion of patients with Common Terminology Criteria for Adverse Events (CTCAE) Grade 3/4 treatment emergent adverse events (TEAEs); proportion of patients with treatment-related adverse events and serious adverse events as assessed by NCI CTCAE v5.0
Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). System Organ Class (SOC) and Preferred Term (PT) will be attached to the clinical database. AE severity will be graded using the CTCAE.
All AEs will be summarized (incidence) and listed by the System Organ Class (SOC), preferred term, toxicity/severity grade, and causal relationship to study medication. In addition, separate summaries of SAEs and Grade 3 and 4 AEs will be presented.
Measured: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on bone marrow toxicities
Incidence and duration of Grade 4 neutropenia in Cycle 1
for each treatment cycle and all cycles combined
Measured: Approximately 3 weeks for each patient
Secondary outcomes (17)
Chemoprotective effects of ALRN-6924 on alopecia induced by TAC
Incidence of Grade 2 alopecia after treatment with ALRN-6924 plus TAC
Measured: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on neutropenia
Incidence rate of grade 4 neutropenia for each treatment cycle and all cycles combined
Measured: Approximately 24 weeks
Time to absolute neutrophil count (ANC) recovery in Cycle 1
Time in days from ANC nadir to recovery
Measured: 3 weeks (cycle 1)
Depth of ANC nadir in Cycle 1
Lowest ANC count during cycle 1
Measured: 3 weeks (cycle 1)
Chemoprotective effects of ALRN-6924 on Grade ≥3 neutropenia for each cycle and all cycles
CTCAE v5 grade 3 neutropenia
Measured: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on thrombocytopenia
CTCAE v5 grade ≥3 thrombocytopenia
Measured: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on anemia
CTCAE v5 grade ≥3 anemia
Measured: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on febrile neutropenia
Incidence of febrile neutropenia for each cycle and all cycles
Measured: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on the need for chemotherapy dose reductions
Number of dose reductions of chemotherapy due to chemotherapy-related toxicity for each cycle and all cycles
Measured: Approximately 24 weeks
Use of myeloid growth factors
Number of instances of granulocyte colony-stimulating factors (G-CSF) use to treat Grade 4 neutropenia for each cycle and all cycles
Measured: Approximately 24 weeks
Need for red blood cell transfusions
Number of red blood cell (RBC) transfusions during each cycle and all cycles
Measured: Approximately 24 weeks
Need for platelet transfusions
Number of platelet transfusions during each cycle and all cycles
The ALRN-6924 PK profile with and without AC chemotherapy will be compared.
Measured: Approximately 24 weeks
PK of ALRN-6924
PK parameters (e.g., area-under-the-curve [AUC]) of ALRN-6924
Measured: Cycle 1 (each cycle is 21 days)
PK of ALRN-6924
PK parameters (e.g., maximum concentration [Cmax] of ALRN-6924
Measured: Cycle 1 (each cycle is 21 days)
PK of ALRN-6924
PK parameters (e.g., time of Cmax [tmax]) of ALRN-6924
Measured: Cycle 1 (each cycle is 21 days)
PK of ALRN-6924
PK parameters (e.g., half-life [t1/2]) of ALRN-6924
Measured: Cycle 1 (each cycle is 21 days)
Efficacy of chemotherapy
Tumor response after TAC chemotherapy: proportion of patients with pCR after completion of neoadjuvant chemotherapy and surgery, per local standard of care and institutional policies
Measured: Approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start9 Jan 2023
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Why it stopped: The study has been terminated early given that the first four patients enrolled have experienced Grade 4 neutropenia and alopecia after cycle 1 and as such failed to meet the primary endpoint and the main secondary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Chemotherapy-induced MyelosuppressionStudies 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aileron Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622058
- Sponsor's protocol ID
- ALRN-6924-1-05
- Other IDs
- 2022-000158-27
- Status last verified
- Feb 2023
- First submitted
- 1 Jun 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Clinical Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, as a Chemoprotection Agent in Patients With TP53-Mutated, HER2 Negative Breast Cancer Receiving Neoadjuvant or Adjuvant Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)
- ClinicalTrials.gov ID
- NCT05622058
- Acronym / sponsor ID
- ALRN-6924-1-05
- Keywords
- ALRN-6924, Chemoprotection, Myelosuppression, Cell cycle arrest, p53 mutation, Breast cancer, Alopecia, Neutropenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been terminated early given that the first four patients enrolled have experienced Grade 4 neutropenia and alopecia after cycle 1 and as such failed to meet the primary endpoint and the main secondary endpoint.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aileron Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 18 Nov 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.
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Chemotherapy affects cells that are dividing, whether they are tumor cells or healthy cells (including, bone marrow cells, hair follicle cells, and epithelial cells lining the gastrointestinal tract). ALRN-6924 is designed to stop cell division in healthy cells but not in tumor cells because they have a mutation of the TP53 gene. When this happens, tumor cells will still be destroyed by the chemotherapy but healthy cells that are not dividing may be spared from chemotherapy damage and the patient should have less side effects.
Detailed description
This is a Phase 1b, open-label, single-arm, multicenter clinical trial for evaluation of safety, tolerability and chemoprotection effects of ALRN-6924 combined with chemotherapy in patients with TP53-mutated, HER2 negative breast cancer without distant organ metastases. All patients will receive the neoadjuvant or adjuvant chemotherapy regimen known as TAC. TAC consists of doxorubicin 50 mg/m2 IV infusion, docetaxel 75mg/m2 IV infusion and cyclophosphamide 500 mg/m2 IV infusion, given on Day 1 of every 3-week cycle for a total of 4-6 treatment cycles according to each patient's individual needs, individual institutional policies and standards of care, as well as investigator discretion. ALRN-6924 1.2 mg/kg will be administered on 3 consecutive days in each treatment cycle, Days 0-2. Prophylactic administration of G-CSF prior to the first instance of Grade 4 neutropenia is not allowed in Cycle 1. Myeloid growth factor support with filgrastim should be administered immediately if a patient is diagnosed with Grade 4 neutropenia.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALRN-6924 Dose plus TAC | Experimental | Drug: ALRN-6924, Drug: TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)ALRN-6924 plus Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Females and males, age ≥18years.
- Patients who, in the investigator's judgment, are able to understand and willing to comply with the requirements of this clinical trial and to provide written informed consent.
- Histologically confirmed diagnosis of HER2 negative breast cancer
- Candidate to receive chemotherapy with TAC regimen
- Presence of p53 mutation(s) in tumor tissue as assessed by next generation sequencing (NGS).
Key exclusion criteria (17 listed)
- Known hypersensitivity to any component of study treatment.
- Prior chemotherapy for HER2 negative breast cancer.
- 1. Presence of distant metastases. Nodal involvement is acceptable.
- Uncontrolled intercurrent illness including but not limited to:
- Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker.
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 |
|---|---|---|
| ALRN-6924ALRN-6924 administered in every chemotherapy treatment cycle as an IV infusion over 1 hour on Days 0 (approximately 18 hours prior to chemotherapy administration), 1 (approximately 1 hour prior to chemotherapy administration), and 2 (approximately 24 hours after the second infusion of ALRN-6924). | Drug | ALRN-6924 Dose plus TAC |
| TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)TAC will be administered as an IV infusion on Day 1 of every 3-week treatment cycle | Drug | ALRN-6924 Dose plus TAC |
Primary outcome
Safety and tolerability of ALRN-6924 in combination with TAC chemotherapy
Time frame: Approximately 24 weeks
Proportion of patients with Common Terminology Criteria for Adverse Events (CTCAE) Grade 3/4 treatment emergent adverse events (TEAEs); proportion of patients with treatment-related adverse events and serious adverse events as assessed by NCI CTCAE v5.0 Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). System Organ Class (SOC) and Preferred Term (PT) will be attached to the clinical database. AE severity will be graded using the CTCAE. All AEs will be summarized (incidence) and listed by the System Organ Class (SOC), preferred term, toxicity/severity grade, and causal relationship to study medication. In addition, separate summaries of SAEs and Grade 3 and 4 AEs will be presented.
Chemoprotective effects of ALRN-6924 on bone marrow toxicities
Time frame: Approximately 3 weeks for each patient
Incidence and duration of Grade 4 neutropenia in Cycle 1 for each treatment cycle and all cycles combined
17 secondary outcomes
Chemoprotective effects of ALRN-6924 on alopecia induced by TAC
Time frame: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on neutropenia
Time frame: Approximately 24 weeks
Time to absolute neutrophil count (ANC) recovery in Cycle 1
Time frame: 3 weeks (cycle 1)
Depth of ANC nadir in Cycle 1
Time frame: 3 weeks (cycle 1)
Chemoprotective effects of ALRN-6924 on Grade ≥3 neutropenia for each cycle and all cycles
Time frame: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on thrombocytopenia
Time frame: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on anemia
Time frame: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on febrile neutropenia
Time frame: Approximately 24 weeks
Chemoprotective effects of ALRN-6924 on the need for chemotherapy dose reductions
Time frame: Approximately 24 weeks
Use of myeloid growth factors
Time frame: Approximately 24 weeks
Need for red blood cell transfusions
Time frame: Approximately 24 weeks
Need for platelet transfusions
Time frame: Approximately 24 weeks
PK of ALRN-6924
Time frame: Cycle 1 (each cycle is 21 days)
PK of ALRN-6924
Time frame: Cycle 1 (each cycle is 21 days)
PK of ALRN-6924
Time frame: Cycle 1 (each cycle is 21 days)
PK of ALRN-6924
Time frame: Cycle 1 (each cycle is 21 days)
Efficacy of chemotherapy
Time frame: Approximately 24 weeks
Results and safety
The study was stopped early (reason given: The study has been terminated early given that the first four patients enrolled have experienced Grade 4 neutropenia and alopecia after cycle 1 and as such failed to meet the primary endpoint and the main secondary endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALRN-6924 and TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2) in people with Prevention of Chemotherapy-induced Myelosuppression, run by Aileron Therapeutics, Inc. at 14 sites in 4 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 15 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 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Bosnia and Herzegovina, Serbia, Bulgaria. 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 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.
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 was stopped early (reason given: The study has been terminated early given that the first four patients enrolled have experienced Grade 4 neutropenia and alopecia after cycle 1 and as such failed to meet the primary endpoint and the main secondary endpoint.). 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?
Safety and tolerability of ALRN-6924 in combination with TAC chemotherapy (time frame: Approximately 24 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 27 Feb 2023.