Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 50 for:    acalabrutinib

Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03932331
Recruitment Status : Not yet recruiting
First Posted : April 30, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is an open-label, two-part study to assess the safety, tolerability, pharmacokinetics and clinical efficacy of acalabrutinib in Chinese adult subjects with R/R MCL, CLL and other B-cell malignancies. The study is divided into 2 parts: Phase 1 portion and Phase 2 portion.

Condition or disease Intervention/treatment Phase
Phase I: Relapsed or Refractory B-cell Malignancies Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia Drug: Acalabrutinib Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : October 28, 2022


Arm Intervention/treatment
Experimental: Acalabrutinib
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity.
Drug: Acalabrutinib
Acalabrutinib 100 mg orally twice daily




Primary Outcome Measures :
  1. Phase 1: Number of participants with Adverse Events (AEs) [ Time Frame: approximately 2 years. ]
  2. Phase 2: Overall Response Rate (ORR) [ Time Frame: up to 3 years ]
  3. Phase 1: Pharmacokinetics Characterization after single dose, AUC (Area under the plasma concentration-time curve (from zero to infinity) ) [ Time Frame: approximately 1 month. ]
  4. Phase 1: Pharmacokinetics Characterization after single dose, AUC0-12 (Area under the plasma concentration-time curve (from zero to 12 hours)) [ Time Frame: approximately 1 month. ]
  5. Phase 1: Pharmacokinetics Characterization after single dose, AUC0-t (Area under the plasma concentration-time curve (from zero to the time of the last measurable concentration)) [ Time Frame: approximately 1 month. ]
  6. Phase 1: Pharmacokinetics Characterization after single dose, Cmax (Maximum observed plasma concentration) [ Time Frame: approximately 1 month. ]
  7. Phase 1: Pharmacokinetics Characterization after single dose, tmax (Time to maximum concentration) [ Time Frame: approximately 1 month. ]
  8. Phase 1: Pharmacokinetics Characterization after single dose, CL/F (Oral clearance) [ Time Frame: approximately 1 month. ]
  9. Phase 1: Pharmacokinetics Characterization after single dose, Vz/F (Volume of distribution) [ Time Frame: approximately 1 month. ]
  10. Phase 1: Pharmacokinetics Characterization after single dose, λz (Terminal rate constant) [ Time Frame: approximately 1 month. ]
  11. Phase 1: Pharmacokinetics Characterization after single dose, t1/2 (Terminal half life) [ Time Frame: approximately 1 month. ]
  12. Phase 1: Pharmacokinetics Characterization after single dose, MR_Cmax (metabolite-to-parent ratio, Maximum observed plasma concentration) [ Time Frame: approximately 1 month. ]
  13. Phase 1: Pharmacokinetics Characterization after single dose, MR_AUC (metabolite-to-parent ratio, Area under the plasma concentration-time curve (from zero to infinity)) [ Time Frame: approximately 1 month. ]
  14. Phase 1: Pharmacokinetics Characterization after multiple doses, AUCτ,ss (Area under the plasma concentration-time curve across the dosing interval at steady state) [ Time Frame: approximately 1 month. ]
  15. Phase 1: Pharmacokinetics Characterization after multiple doses, Cmax,ss (Maximum observed plasma concentration at steady state) [ Time Frame: approximately 1 month. ]
  16. Phase 1: Pharmacokinetics Characterization after multiple doses, Cmin,ss (Minimum observed plasma drug concentration at steady state) [ Time Frame: approximately 1 month. ]
  17. Phase 1: Pharmacokinetics Characterization after multiple doses, tmax,ss (Time to maximum concentration at steady stage) [ Time Frame: approximately 1 month. ]
  18. Phase 1: Pharmacokinetics Characterization after multiple doses, CLss/F (Oral clearance at steady stage) [ Time Frame: approximately 1 month. ]
  19. Phase 1: Pharmacokinetics Characterization after multiple doses, MR_ AUCτ (metabolite-to-parent ratio, Area under the plasma concentration-time curve across the dosing interval) [ Time Frame: approximately 1 month. ]
  20. Phase 1: Pharmacokinetics Characterization after multiple doses, TCP (Temporal change parameter in systemic exposure (also known as: time dependency, temporal parameter change, linearity index); calculated as AUCτ(steady state)/AUC(first dose)) [ Time Frame: approximately 1 month. ]
  21. Phase 1: Pharmacokinetics Characterization after multiple doses, Rac(AUC) (Accumulation ratio calculated as AUCτ(steady state)/AUCτ(first dose)) [ Time Frame: approximately 1 month. ]
  22. Phase 1: Pharmacokinetics Characterization after multiple doses, Rac(Cmax) (Accumulation ratio calculated as Cmax,ss/Cmax) [ Time Frame: approximately 1 month. ]

Secondary Outcome Measures :
  1. Phase 1: Tumor response (number of patients with Complete Response (CR), Partial Response (PR), Stable Diseaase (SD), Progression of Disease (PD)) [ Time Frame: up to 2 years. ]
  2. Phase 2: Number of participants with Adverse Events (AEs) [ Time Frame: approximately 2 year. ]
  3. Phase 2: Plasma concentration of acalabrutinib and its major metabolite (sparse sampling) [ Time Frame: up to 1 month. ]
  4. Phase 2: Progression free survival (PFS) [ Time Frame: up to 3 years ]
  5. Phase 2: Duration of Response (DoR) [ Time Frame: up to 3 years ]
  6. Phase 2: Time To Response (TTR) [ Time Frame: up to 3 years ]
  7. Phase 2: Overall Survival (OS) [ Time Frame: up to 3 years ]
  8. Phase 2: Time to Next Treatment (for R/R CLL only) [ Time Frame: up to 3 years ]
  9. Phase 2: Minimum Residual Disease Rate (for R/R CLL only) [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria

  1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  2. Chinese subjects at least 18 years of age at the time of study entry.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  4. Adequate hematological and organ function.
  5. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
  6. Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14) (q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5). Disease had relapsed after or been refractory to previous treatment.
  7. Diagnosis of CLL that meets published diagnostic criteria. Must have received ≥ 1 prior systemic therapies for CLL.
  8. Active disease per iwCLL 2018 criteria that requires treatment. (CLL only)
  9. Other relapsed/refractory B-cell malignancies without stand of care (phase 1 only).

Exclusion criteria

  1. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject had been disease free for ≥2 years or which would not have limited survival to <2 years.
  2. Significant cardiovascular disease.
  3. Known central nervous system involvement of lymphoma/leukemia or leptomeningeal disease.
  4. Known history of HIV, serologic status reflecting active hepatitis B or C infection.
  5. Major surgery within 4 weeks before first dose of study drugs.
  6. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
  7. Required or received anticoagulation with warfarin or equivalent vitamin K antagonist (eg, phenprocoumon).
  8. Prior exposure to a BCR or BCL-2 inhibitor.
  9. Use of a strong inhibitor or inducer of CYP3A.
  10. Breastfeeding or pregnant.

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): NCT03932331


Contacts
Layout table for location contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Layout table for location information
China
Research Site Not yet recruiting
Beijing, China, 100044
Research Site Not yet recruiting
Beijing, China, 100142
Research Site Not yet recruiting
Beijing, China, 100191
Research Site Not yet recruiting
Changchun, China, 130021
Research Site Not yet recruiting
Changzhou, China, 272100
Research Site Withdrawn
Chengdu, China, 610041
Research Site Not yet recruiting
Chengdu, China, 610041
Research Site Not yet recruiting
Dalian, China, 116027
Research Site Not yet recruiting
Fuzhou, China
Research Site Not yet recruiting
Hangzhou, China, 310003
Research Site Not yet recruiting
Hangzhou, China, 310022
Research Site Not yet recruiting
Harbin, China, 150049
Research Site Not yet recruiting
Nanjing, China, 210029
Research Site Not yet recruiting
Shanghai, China, 200032
Research Site Not yet recruiting
Tianjin, China, 300020
Research Site Not yet recruiting
Zhengzhou, China, 450008
Research Site Not yet recruiting
Zhengzhou, China, 450052
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: Jun Zhu, Prof Beijing Cancer Hospital

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03932331     History of Changes
Other Study ID Numbers: D8220C00007
2018L02939 ( Registry Identifier: CFDA/ NMPA )
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Leukemia
Neoplasms
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin