A Phase I Study of YY-20394 in Patients With B Cell Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT03757000|
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|B-cell Lymphoma Recurrent B-cell Chronic Lymphocytic Leukemia||Drug: YY-20394||Phase 1|
This is a two-part study comprised of a dose escalation part and a dose expansion part.
In the dose escalation part single patient cohorts will be dosed until a single related toxicity of Grade ≥ 3 or a Dose Limiting Toxicity (DLT) is observed. If this occurs, the study will switch to a conventional oncology 3+3 design (3 patients per dose cohort, with the potential to add an additional 3 patients if toxicity is observed) and escalation will continue until the maximum tolerated dose (MTD) is reached and a recommended Phase II (RP2D) dose is determined. Once the MTD is established a separate dose expansion part will enroll up total additional 12 patients at the RP2D.
In this clinical trial, YY-20394 is given orally once daily. A treatment cycle is defined as 28 days. YY-20394 was given until disease progression, unacceptable toxicity, or withdrawal from the study. The protocol was initiated with a single-patient cohort, treated with oral YY-20394 20 mg once daily (QD). Subsequent cohorts used a 3+3 design and evaluated doses of 40-320mg QD. Adverse events (AEs) were graded by NCI-CTCAE v4.0. Efficacy was assessed according to IWG-NHL and CLL consensus response criteria.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||dose escalation|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of YY-20394 Given Orally to Patients With Relapsed or Refractory B Cell Hematologic Malignancies|
|Actual Study Start Date :||December 25, 2017|
|Estimated Primary Completion Date :||March 30, 2019|
|Estimated Study Completion Date :||May 30, 2019|
YY-20394 is a selective inhibitor of the delta isoform of phosphatidylinositol 3- kinase (PI3Kδ).
YY-20394 for clinical use is presented as a sterile tablets at 20 mg, or 100 mg doses. The drug product is intended for oral administration.Preset cohorts of 3-6 subjects will be enrolled sequentially at doses of 20, 40, 80, 140, 200, 260 and 320 mg/day.
YY-20394 is a new type of PI3K-δ selective inhibitor which differs structurally from idelalisib and its analogs, showing high potency against PI3Kδ, but with markedly improved selectivity (>1,000-fold selectivity for PI3K-δ versus PI3Kγ). This higher selectivity for PI3Kδ may decrease the risk of serious infection seen with idelalisib and especially with duvelisib due to strong immune suppression.Preclinical evaluation has demonstrated improved efficacy and safety for YY-20394 compared to idelalisib.
- Dose limited toxicities evaluated with NCI-CTC AE v4.0 [ Time Frame: within 28 days after the first dose ]Incidence of dose limited toxicities and associated dose of YY-20394
- Adverse events evaluated by NCI CTCAE v4.0 [ Time Frame: from the first dose to within 30 days after the last dose ]Incidence of adverse events and associated dose of YY-20394
- Plasma concentration of YY-20394 [ Time Frame: within 56 days after the first dose ]This composite endpoint will measure the plasma concentration of YY-20394.
- Objective response rate [ Time Frame: within 30 days after the last dose ]the proportion of subjects who have a Complete Response or Partial Response
- Disease control rate [ Time Frame: within 30 days after the last dose ]the proportion of subjects who have a Complete Response or Partial Response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757000
|Contact: Hanying Bao, MD,PhD||86 email@example.com|
|Contact: Yuanyuan Xu, M.S.||86 21-51320088 ext firstname.lastname@example.org|
|Peking Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100142|
|Contact: Yuqin Song, MD,PhD 86 10-88140650 email@example.com|
|Contact: Meifeng Tu, MD,PhD 86 10-88121122 firstname.lastname@example.org|
|Principal Investigator: Yuqin Song, MD,PhD|
|Sub-Investigator: Meifeng Tu, MD,PhD|
|Sub-Investigator: Lingyan Ping, MD,PhD|
|Jiangsu Province Hospital||Not yet recruiting|
|Nanjing, Jiangsu, China, 210029|
|Contact: Jiangyong Li, MD,PhD 86 25-83714511 email@example.com|
|Contact: Wei Xu, MD,PhD 86 25-83714511 firstname.lastname@example.org|
|Principal Investigator: Jianyong Li, MD,PhD|
|Sub-Investigator: Meifeng Tu, MD,PhD|
|Hematology Hospital of Chinese Academy of Medical Sciences||Recruiting|
|Tianjin, Tianjin, China, 300020|
|Contact: Lugui Qiu, MD,PhD 86 22-23909172 email@example.com|
|Contact: Junyuan Qi, MD,PhD 86 22-23909999 firstname.lastname@example.org|
|Principal Investigator: Lugui Qiu, MD,PhD|
|Sub-Investigator: Junyuan Qi, MD,PhD|
|Study Director:||Hanying Bao, PhD||Shanghai YingLi Pharmaceutical Co. Ltd.|