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Acute Myeloid LeukemiaPhase 1/2NCT03055286

Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients

A Phase 1/2 study testing CWP232291 in people with Acute Myeloid Leukemia, run by JW Pharmaceutical at 5 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multicenter (S. Korea/US), Phase Ib, open-label, dose-finding study to assess safety, PK, PD, and preliminary efficacy of CWP232291 administered in combination with ara-C in subjects with relapsed or refractory AML. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
CWP232291
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
5 sitesin 2 countries
Study dates
6 Feb 2017to 26 Aug 2025
Phase
Phase 1/2
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

  • Understands and is willing to sign an informed consent form (ICF) prior to initiation of any study-specific procedure.
  • 18 years of age at the time of consenting.
  • A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification that is progressing.
  • Has failed (refractory) or relapsed after no more than 2 prior regimens, and for whom for whom no other standard therapy options are available.
  • Subjects with prior autologous and allogeneic hematopoietic stem cell transplantation (allo HSCT) are eligible.
  • Adequate laboratory results including the following:
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  • Serum creatinine ≤ 2.0 mg/dL
  • Total bilirubin ≤ 1.5 x upper limit of institutional normal (ULN), unless due to Gilbert's syndrome
  • Aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 x ULN, unless due to organ leukemic involvement
  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
  • The subject should be off any anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational agents for at least 14 days or 5 half lives, whichever is greater, prior to enrollment with the exception of hydroxyurea. All prior treatment-related non-hematologic toxicities must have resolved to ≤ grade 2 prior to screening.
  • Female subject of childbearing potential (ie, premenopausal or not surgically sterile) must agree to use effective contraception from Day 1 until 28 days after the last dose of study drug, and have a negative serum or urine pregnancy test within 2 weeks prior to Day 1. Sexually active male subjects must also use effective contraception from Day 1 until 90 days after the last dose of any study drug.
  • Female subject must agree not to breastfeed at screening and throughout the study period and for 45 days after the final study drug administration. Female subject must not donate ova starting at screening and throughout the study period and for 45 days after the final study drug administration.
  • Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
  • Agree to adhere to all study protocol requirements.

Who cannot join

  • Subject has BCR-ABL-positive leukemia (Chronic myeloid leukemia [CML] in blast crisis).
  • Subject is diagnosed as acute promyelocytic leukemia (APL).
  • Subject has AML secondary to prior chemotherapy.
  • Subject has active clinically significant graft versus host disease (GVHD) or is on treatment with systemic corticosteroids for GVHD (except grade 1 skin GVHD). At least 3 months must have elapsed since completion of allogeneic stem cell transplantation.
  • Subject had a myocardial infarction within 6 months of enrollment, heart failure (New York Heart Association (NYHA) Class III or IV), uncontrolled angina, severe uncontrolled ventricular arrhythmias, left ventricular ejection fraction (LVEF) ≤ 40% or evidence of acute ischemia or active conduction system abnormalities.
  • Presence of a systemic fungal, bacterial, viral or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
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  • Known in tolerance and allergy to cytarabine.
  • Active central nervous system (CNS) disease.
  • Known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C.
  • Prior exposure to CWP232291.
  • Pregnant or breastfeeding women.
  • Suitable for imminent bone marrow transplant, or within 4 weeks of one.
  • Major surgery within 4 weeks prior to the first study dose.
  • Concurrent other malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

South Korea3 sites

  • Samsung medical center

    Seoul, Gangnam-gu

  • Seoul National University Hospital

    Seoul, Jongno-gu

  • Asan Medical Center

    Seoul, Songpa-Gu

Other trials in South Korea

United States2 sites

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Phase 1b/2a Clinical Study of CWP232291 in Combination With Cytarabine in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)

This is a multicenter (S. Korea/US), Phase Ib, open-label, dose-finding study to assess safety, PK, PD, and preliminary efficacy of CWP232291 administered in combination with ara-C in subjects with relapsed or refractory AML.

The primary objectives in phase 2a is to assess the efficacy of CWP232291 administered in combination with cytarabine (response rate complete remission [RR-CR]/complete remission with incomplete blood count recovery [CRi]/partial remission [PR]).

Being tested
CWP232291
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • CWP232291Drug

    For cohort 1-3, a fixed dose of ara-C at 1 G/m2 will be administered IV over 2 hours daily from Day 1 to Day 5 following CWP232291 infusion.

    For cohort 4, a fixed dose of ara-C at 1 G/m2 will be administered IV over 2 hours daily from Day 1 to Day 7 following 250 mg/m2 CWP232291 infusion.

Study groups in NCT03055286
Study groupRoleWhat they receive
CWP232291 in combination with cytarabine (ara-C)ExperimentalNot described
Receives: Drug: CWP232291

What is being measured

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

  1. Recommended Phase 2 dose

    To be determinded Recommended Phase 2 dose (RP2D) of CWP232291 in combination with cytarabine (ara-C), administered to subjects with relapsed or refractory AML.

    Measured: up to 4 weeks

Secondary outcomes (6)

  1. Cmax as a Pharmacokinetic (PK) assessments for CWP232291

    maximum plasma concentration (Cmax)

    Measured: 3rd Cycle (each cycle = 28 days), Cycle 1 Day 1: Pre, 0.5hr, 1hr, 2hr, 3hr, 4hr, 5hr, 8hr, and 24hr after the start of infusion in Part A and at Cycle 1 Day 1: Pre, 2hr, 4hr, 8hr, and 24hr after the start of infusion in Part B.

  2. tmax as a Pharmacokinetic (PK) assessments for CWP232291

    time to maximum observed plasma concentration (tmax)

    Measured: 3rd Cycle (each cycle = 28 days), Cycle 1 Day 1: Pre, 0.5hr, 1hr, 2hr, 3hr, 4hr, 5hr, 8hr, and 24hr after the start of infusion in Part A and at Cycle 1 Day 1: Pre, 2hr, 4hr, 8hr, and 24hr after the start of infusion in Part B.

  3. AUC0-t as a Pharmacokinetic (PK) assessments for CWP232291

    area under the time-concentration curve from time zero to the last measurable concentration (AUC0-t)

    Measured: 3rd Cycle (each cycle = 28 days), Cycle 1 Day 1: Pre, 0.5hr, 1hr, 2hr, 3hr, 4hr, 5hr, 8hr, and 24hr after the start of infusion in Part A and at Cycle 1 Day 1: Pre, 2hr, 4hr, 8hr, and 24hr after the start of infusion in Part B.

  4. AUC0-∞ as a Pharmacokinetic (PK) assessments for CWP232291

    area under the time concentration curve from time zero to infinity (AUC0-∞)

    Measured: 3rd Cycle (each cycle = 28 days), Cycle 1 Day 1: Pre, 0.5hr, 1hr, 2hr, 3hr, 4hr, 5hr, 8hr, and 24hr after the start of infusion in Part A and at Cycle 1 Day 1: Pre, 2hr, 4hr, 8hr, and 24hr after the start of infusion in Part B.

  5. AUC0-τ as a Pharmacokinetic (PK) assessments for CWP232291

    area under the time concentration curve from time zero the end of the dosage interval (AUC0-τ)

    Measured: 3rd Cycle (each cycle = 28 days), Cycle 1 Day 1: Pre, 0.5hr, 1hr, 2hr, 3hr, 4hr, 5hr, 8hr, and 24hr after the start of infusion in Part A and at Cycle 1 Day 1: Pre, 2hr, 4hr, 8hr, and 24hr after the start of infusion in Part B.

  6. t½ as a Pharmacokinetic (PK) assessments for CWP232291

    terminal elimination half-life (t½)

    Measured: 3rd Cycle (each cycle = 28 days), Cycle 1 Day 1: Pre, 0.5hr, 1hr, 2hr, 3hr, 4hr, 5hr, 8hr, and 24hr after the start of infusion in Part A and at Cycle 1 Day 1: Pre, 2hr, 4hr, 8hr, and 24hr after the start of infusion in Part B.

Timeline

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

  1. First posted16 Feb 2017
  2. Study start6 Feb 2017
  3. Primary completion26 Aug 2025
  4. Study completion26 Aug 2025

Why it stopped: business/strategic reason

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03055286
Sponsor's protocol ID
JW-231A-103
Status last verified
Dec 2025
First submitted
3 Feb 2017
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CWP232291 in people with Acute Myeloid Leukemia, run by JW Pharmaceutical at 5 sites in 2 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 14 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea, 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?

The study was stopped early (reason given: business/strategic reason). 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?

Recommended Phase 2 dose (time frame: up to 4 weeks). 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 NCT03055286.

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 26 Dec 2025.

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