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Clinical Study of CWP232291 in Relapsed or Refractory Myeloma Patients

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ClinicalTrials.gov Identifier: NCT02426723
Recruitment Status : Recruiting
First Posted : April 27, 2015
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical

Brief Summary:

This is a Phase 1a/1b, multicenter, open-label, two-part study in subjects with relapsed or refractory MM:

  • Phase 1a: single agent CWP232291. Dose-finding followed by cohort expansion at the maximum tolerated dose (MTD) or optimal dose as determined by the Safety Review Committee (SRC).
  • Phase 1b: CWP232291 in combination with lenalidomide and dexamethasone. Dose-finding followed by cohort expansion at the combination therapy MTD or optimal dose as determined by the SRC.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Phase 1a: CWP232291 Drug: Phase 1b: CWP232291, Lenalidomide, Dexamethasone Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Multicenter, Open Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CWP232291 Administered Intravenously Either Alone or in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Myeloma (MM)
Study Start Date : October 2015
Estimated Primary Completion Date : September 2019
Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: CWP232291

Phase 1a: single administration of CWP232291 ,

Phase 1b: CWP232291 combination with Lenalidomide and Dexamethasone

Drug: Phase 1a: CWP232291
CWP232291 administered alone twice weekly every 4 weeks.

Drug: Phase 1b: CWP232291, Lenalidomide, Dexamethasone
CWP232291 administered twice weekly every 4 weeks. Lenalidomide and Dexamethasone administered per standard therapy.




Primary Outcome Measures :
  1. Recommended dose of Phase 2 trial of CWP232291 [ Time Frame: up to 4 weeks ]

Secondary Outcome Measures :
  1. Cmax as a pharmacokinetic parameter of 'CWP232291' [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion ]
    Peak plasma concentration(Cmax) of 'CWP232291'

  2. AUC as a pharmacokinetic parameter of 'CWP232291' [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion ]
    Area under the plasma concentration versus time curve (AUC) of 'CWP232291'

  3. Cmax as a pharmacokinetic parameter of metabolites of ' CWP232204' [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion ]
    Peak Plasma Concentration (Cmax) of metabolites of 'CWP232291'

  4. AUC as a pharmacokinetic parameter of metabolites of ' CWP232204' [ Time Frame: Predose, 0.25, 0.5, 0.75, 1, 1.5 , 2 , 4 , 8, 12, 24 hours after the start of infusion ]
    Area under the plasma concentration versus time curve (AUC) of metabolites of 'CWP232291'



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to understand and then sign an informed consent form (ICF) prior to initiation of any study-specific procedure and treatment.
  2. ≥ 18 years of age.
  3. Confirmed measurable MM based on the following:

    • Serum M component (≥ 0.5 g/dL), or
    • Urine M protein ≥ 200 mg/24 hours), or
    • Serum immunoglobulin free light chains ≥ 10 mg/dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio), or
    • Non-secretory disease measurable with bone marrow biopsy or radiography.
  4. Failed 2 or more prior standard MM therapies, and >100 days post autologous bone marrow transplant prior to first dose for transplanted subjects. Prior lenalidomide is permitted.
  5. In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be ≥ 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. Persistent clinically significant toxicities from prior chemotherapy or radiotherapy must not be greater than Grade 1.
  6. Eastern Cooperative Oncology Group (ECOG) performance score 0-2 (Appendix 3).
  7. Adequate bone marrow function:

    • Absolute neutrophil count (ANC) ≥ 1000/mm3, independent of growth factor support;
    • Platelet count ≥ 75,000/mm3;
    • Hb ≥ 9 g/dL (independent of transfusions or erythropoiesis-stimulating agents [ESA]).
  8. Adequate renal function:

    • Serum creatinine ≤ 2.5 mg/dL;
    • Creatinine clearance (CrCl) ≥ 60 mL/minute (Cockcroft-Gault).
  9. Adequate hepatic function:

    • Total bilirubin < 2.5 x upper limit of normal (ULN); direct bilirubin < 2 x ULN for Gilbert's syndrome;
    • Alkaline phosphatase (AP) ≤ 2.5 x ULN, unless considered due to organ leukemic involvement;
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x ULN.

11. Women of child-bearing potential (ie, women who are premenopausal or not surgically sterile):

  • Two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 4 weeks after discontinuing study drugs, and
  • Negative serum or urine pregnancy tests during screening and then within 3 days prior to Day 1. 12. Sexually active men - effective contraceptive methods in subject and partner from the time of informed consent and until ≥ 4 weeks after discontinuing study drugs. 13. Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  1. Chemotherapy or immunotherapy < 5 half-lives prior to screening.
  2. Not recovered to Grade 1 from adverse effects of prior myeloma therapy or radiotherapy prior to screening.
  3. Systemic corticosteroids < 1 week prior to Day 1 in Phase 1a. Subjects may receive stable physiologic replacement doses of glucocorticoids (up to the equivalent of 10 mg daily prednisone) as maintenance therapy for adrenal insufficiency.
  4. Uncontrolled intercurrent illness including infections and psychiatric illness/social situations that may limit compliance with protocol requirements or the evaluation of study drugs.
  5. Active cardiovascular disease including myocardial infarction (MI) < 6 months of screening, symptomatic coronary artery disease (CAD), arrhythmias, hypertension, or heart failure not controlled by medication.
  6. History of deep venous thrombosis and pulmonary embolism (Phase 1b).
  7. Anticoagulants < 7 days prior to Day 1. Aspirin is permitted in Phase 1b per standard of care with lenalidomide-based therapy.
  8. Active central nervous system (CNS) disease.
  9. Known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C.
  10. Pregnant or nursing women.
  11. History of hypersensitivity to lenalidomide (Part B only)
  12. History of other active malignancies < 3 years prior to screening except basal cell carcinoma, low grade Gleason score ≤ 6 prostate cancer that has been removed with undetectable prostate-specific antigen (PSA), and in situ cervical carcinoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426723


Contacts
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Contact: Sandra Silberman, MD, PhD Sandra.Silberman@synteracthcr.com

Locations
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United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Elisabet Manasanch, MD         
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Sung-Soo Yoon, MD         
Seoul St.Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chang-Ki Min, MD         
Yonsei Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jin Seok Kim, MD         
Sponsors and Collaborators
JW Pharmaceutical
Investigators
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Principal Investigator: Chang-Ki Min, MD Seoul St. Mary's Hospital
Principal Investigator: Sung-Soo Yoon, MD Seoul National University Hospital
Principal Investigator: Jin Seok Kim, MD Severance Hospital
Principal Investigator: Elisabet Manasanch, MD M.D. Anderson Cancer Center

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Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT02426723     History of Changes
Other Study ID Numbers: JW-231MM-102
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2016

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors