Condition or disease | Intervention/treatment | Phase |
---|---|---|
Part 1:r/r B-cell Malignancies Part 2:B-cell Malignancies | Drug: Orelabrutinib (ICP-022) | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 81 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II,Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies |
Actual Study Start Date : | November 18, 2019 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment 1 (Orelabrutinib)
Patients with r/r MCL receive Orelabrutinib
|
Drug: Orelabrutinib (ICP-022)
ICP-022 The drug product is a white, round, uncoated tablet
|
Experimental: Treatment 2 (Orelabrutinib)
Patients with other types of B-cell malignancies, including:CLL/SLL with/without prior treatment, r/r FL, r/r MZL receive Orelabrutinib
|
Drug: Orelabrutinib (ICP-022)
ICP-022 The drug product is a white, round, uncoated tablet
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL.
Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
Exclusion Criteria:
Contact: Olivia Yang | +1 (609) 524-0684 | ClinicalTrialsInfo@innocarepharma.com |
United States, Louisiana | |
Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Saba Nakhle | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Yucai Wang | |
United States, Montana | |
St Vincent Frontier Cancer Center | Recruiting |
Billings, Montana, United States, 59101 | |
Contact: Cobb W Patrick | |
United States, New Jersey | |
Summit Medical Group | Recruiting |
Florham Park, New Jersey, United States, 07932 | |
Contact: Gallinson H David | |
United States, New York | |
Clinical Research Alliance | Recruiting |
New Hyde Park, New York, United States, 11040 | |
Contact: Coleman Morton | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Michael (Luhua) Wang | |
Contact 713-792-2860 miwang@mdanderson.org | |
United States, Washington | |
Medical Oncology Associates PS (dba Summit Cancer Centers) | Recruiting |
Spokane, Washington, United States, 99201 | |
Contact: Chaudhry Arvind |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | June 18, 2019 | ||||
First Posted Date ICMJE | July 10, 2019 | ||||
Last Update Posted Date | May 26, 2021 | ||||
Actual Study Start Date ICMJE | November 18, 2019 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE |
The maximum tolerated dose (MTD) [ Time Frame: Incidence of dose limiting toxicities (DLTs) up to 28 days ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability] [ Time Frame: Up to 2 years ] The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title ICMJE | A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies | ||||
Official Title ICMJE | A Phase I/II,Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies | ||||
Brief Summary | This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Orelabrutinib (ICP-022)
ICP-022 The drug product is a white, round, uncoated tablet
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
81 | ||||
Original Estimated Enrollment ICMJE |
15 | ||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04014205 | ||||
Other Study ID Numbers ICMJE | ICP-CL-00107 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Beijing InnoCare Pharma Tech Co., Ltd. | ||||
Study Sponsor ICMJE | Beijing InnoCare Pharma Tech Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Beijing InnoCare Pharma Tech Co., Ltd. | ||||
Verification Date | May 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |