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Acute Myeloid LeukemiaPhase 1NCT02909972

Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

A Phase 1 study testing ALRN-6924 and ALRN-6924 in combination with cytarabine in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Aileron Therapeutics, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 alone or in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia or advanced… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ALRN-6924 and ALRN-6924 in combination with cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
6 sitesUnited States
Study dates
Sep 2016to Aug 2019
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

  • Relapsed or refractory acute myeloid leukemia or IPSS-R intermediate/high/very high-risk MDS patients
  • Confirmed or anticipated wild-type TP53
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • Adequate hepatic and renal function
  • Acceptable coagulation function
  • Negative serum or urine pregnancy test within 7 days prior to the first dose of ALRN-6924 for women of child-bearing potential
  • Sufficient wash out from prior therapies and recovery from all significant toxicities

Who cannot join

  • Patients are eligible for available approved standard therapies
  • Prior treatment with MDM2 inhibitor, with protocol specified exceptions
  • Patients with history of allogeneic stem cell transplantation
  • Leukemic blast counts of >25,000/µl
  • Deletion of chromosome 17, or del(17p)
  • Patients with evidence of current central nervous system leukemic involvement
Show all 15Show fewer
  • Known hypersensitivity to any study drug component
  • History of coagulopathy
  • Prior specified cardiovascular risk factors
  • Clinically significant gastrointestinal bleeding within 6 months
  • Clinically significant third-space fluid accumulation
  • Pregnant or lactating females
  • Evidence of any serious and/or unstable pre-existing medical condition that would interfere with patient safety ability to provide informed consent
  • Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C
  • Second malignancy within one year, with protocol specified exceptions

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Denver, Colorado, 80218

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Portland, Oregon, 97239-3098

  • Study site

    Tampa, Florida, 33612

  • Study site

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: A Phase 1/1b Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 Alone and in Combination With Cytarabine (Ara-C) in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome With Wild-Type TP53

Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 alone or in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (WT) TP53

Read the detailed description

Phase I, open label, multi-center dose escalation (DEP) and dose expansion (EXP) study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 in patients with acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (WT) TP53. ALRN-6924 is a stabilized cell-permeating peptide designed to disrupt interaction between the p53 tumor suppression protein and its endogenous inhibitors murine double minute 2 (MDM2) and murine double minute X (MDMX)

Men and women 18 years of age and older with relapsed or refractory acute myeloid leukemia or advanced myelodysplastic syndrome and for which standard treatment(s) are not available or are no longer effective can be enrolled. Treatment of patients in the DEP and EXP phases will continue in the study until documentation of disease progression, unacceptable toxicity, or patient or physician decision to discontinue study participation is made.

Being tested
ALRN-6924, ALRN-6924 in combination with cytarabine
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALRN-6924Drug

    Fixed dose of ALRN-6924 per cohort, administered IV, Days 1, 8, and 15 every 28 days.

  • ALRN-6924 in combination with cytarabineDrug

    Also called ALRN-6924 in combination with Ara-C

    Cytarabine (100 or 200 mg/m2) will be administered as an IV infusion followed by ALRN-6924 on Days 1, 8, and 15 every 28 days.

Study groups in NCT02909972
Study groupRoleWhat they receive
ALRN-6924ExperimentalFixed dose of ALRN-6924 per cohort, administered IV, Days 1, 8, and 15 every 28 days
Receives: Drug: ALRN-6924
ALRN-6924 in combination with cytarabineExperimentalCytarabine (100 or 200 mg/m2) will be administered as an IV infusion followed by ALRN-6924 on Days 1, 8, and 15 every 28 days.
Receives: Drug: ALRN-6924 in combination with cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety and tolerability of ALRN-6924 alone and in combination with cytarabine

    Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0

    Measured: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle is 28 days)

  2. Determine maximum tolerated dose (MTD)

    Determine the dose limiting toxicities (DLT) and the maximum tolerated dose (MTD) or the optimal biological dose (OBD) of ALRN-6924 in adult patients with AML or MDS

    Measured: From the first dose until the end of Cycle 2 (each cycle is 28 days)

Secondary outcomes (6)

  1. Determine PK parameters of ALRN-6924 when administered to patients with acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS)

    Peak Plasma Concentration (Cmax)

    Measured: First 2 cycles (each cycle is 28 days)

  2. Determine PK parameters of ALRN-6924 when administered to patients with acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS)

    Area under the plasma concentration versus time curve [AUC]

    Measured: First 2 cycles (each cycle is 28 days)

  3. Determine immunogenicity of ALRN-6924

    Incidence of anti-ALRN-6924 antibodies

    Measured: Approximately 16 weeks

  4. Determine best overall response, duration of response, morphologic leukemia-free state, leukemia free survival, percentage of MDA patients who have achieved hematologic improvement, changes in transfusion rate and early death rate

    International Working Group (IWG) Criteria (Cheson et al, 2006)

    Measured: Approximately 16 weeks

  5. Determine best overall response, duration of response, morphologic leukemia-free state, leukemia free survival, percentage of MDA patients who have achieved hematologic improvement, changes in transfusion rate and early death rate

    AML response criteria (Dohner et al, 2010)

    Measured: Approximately 16 weeks

  6. Determine best overall response, duration of response, morphologic leukemia-free state, leukemia free survival, percentage of MDA patients who have achieved hematologic improvement, changes in transfusion rate and early death rate

    International Working Group (IWG) Criteria for hematological improvement in MDS (Cheson et al, 2000)

    Measured: Approximately 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionApr 2019
  4. Study completionAug 2019

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02909972
Sponsor's protocol ID
ALRN-6924-1-02
Status last verified
Nov 2019
First submitted
9 Sep 2016
Last updated
19 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALRN-6924 and ALRN-6924 in combination with cytarabine in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Aileron Therapeutics, Inc. at 6 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 7 inclusion and 15 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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 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?

Evaluate the safety and tolerability of ALRN-6924 alone and in combination with cytarabine (time frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle is 28 days)). 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?

On the ClinicalTrials.gov record for NCT02909972.

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 19 Nov 2019.

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