Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

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.

CWP232291

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 \[PR\]).

Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients

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

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

time to maximum observed plasma concentration (tmax)

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

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

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

JW Pharmaceutical

Symptoms and General Pathology

Syndrome

Preleukemia

Myelodysplastic Syndromes

Primary Myelofibrosis

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Bone Marrow Diseases

Precancerous Conditions

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

CWP232291 blocks proliferation of cancer cells via activation of caspases. Active caspase have been shown to target beta-catenin, the hallmark of canonical Wnt signaling, for degradation through caspase-directed cleavage. CWP232291 targets beta-catenin for degradation and thereby inhibits the expression of cell cycle and anti-apoptotic genes such as cyclin D1 and survivin.

Phase I Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients

A Phase I Clinical Study of CWP232291 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome Having Failed Hypomethylating Treatment, and High-Risk Myelofibrosis

If myelosuppression is DLT (Dose-Limiting Toxicity), it will be monitored up to 42 days after start of injection.

Peak Plasma Concentration (Cmax) of 'CWP232291'

Area under the plasma concentration versus time curve (AUC) of 'CWP232291'

Peak Plasma Concentration (Cmax) of metabolites of 'CWP232291'

Area under the plasma concentration versus time curve (AUC) of metabolites of 'CWP232291'

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients	NCT03055286	Acute Myeloid L...	CWP232291	18 Years -	JW Pharmaceutical
Phase I Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients	NCT01398462	Acute Myeloid L... Chronic Myelomo... Myelodysplastic... Myelofibrosis	CWP232291	18 Years -	JW Pharmaceutical
Phase I Clinical Study of CWP232291 in Acute Myeloid Leukemia Patients	NCT01398462	Acute Myeloid L... Chronic Myelomo... Myelodysplastic... Myelofibrosis	CWP232291	18 Years -	JW Pharmaceutical

Spots Global Cancer Trial Database for cwp232291

Every month we try and update this database with for cwp232291 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cwp232291

Every month we try and update this database with for cwp232291 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cwp232291 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.