Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
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|ClinicalTrials.gov Identifier: NCT04586335|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : February 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Breast Cancer Solid Tumor Prostate Cancer Endometrial Cancer||Drug: CYH33||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Open-label, multicenter study which is composed of 2 parts: 1.) dose escalation and 2.) dose expansion. Bayesian optimal interval (BOIN) design will be used to determine the MTD and/or RP2D. Safety, tolerability, PK, PD, and clinical activity will also be evaluated. The CYH33 starting dose of this trial is 20 mg QD in combination with olaparib 300 mg BID. Two additional dose levels of CYH33 at 30 mg QD and 40 mg QD in combination with olaparib 300 mg BID will be evaluated. In the initial dose cohort of 20 mg CYH33 as well as in subsequent dose cohorts 30 mg QD and 40 mg QD in combination with olaparib 300 mg BID, 3 patients will be initially enrolled at each dose level of CYH33. These evaluable patients will be included into this dose level for decision making on dose selection for the next cohort. 10 mg QD of CYH33 will be evaluated in the combination with olaparib 300 mg BID, according to the BOIN design.|
|Masking:||None (Open Label)|
|Official Title:||Open Label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of CYH33, an Oral PI3K Inhibitor in Combination With Olaparib, an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.|
|Actual Study Start Date :||September 28, 2020|
|Estimated Primary Completion Date :||January 28, 2024|
|Estimated Study Completion Date :||January 28, 2024|
Experimental: CYH33 in Combination with Olaparib
CYH33 in Combination with Olaparib; 20 mg CYH33 QD in combination with olaparib 300 mg BID. Two additional dose levels of CYH33 at 30 mg QD and CYH33 at 40 mg QD in combination with olaparib 300 mg BID will be evaluated.
Clinical Activity of CYH33, an Oral α-specific PI3K Inhibitor in Combination with Olaparib, an Oral PARP Inhibitor
Other Name: Olaparib
- Dose Limiting Toxicities (DLT) [ Time Frame: 12 months ]Incidence rate of dose limiting toxicities (DLT) in the first cycle (of 28 days) of each investigated dose levels.
- Tumor objective response rate (ORR) [ Time Frame: 38 months ]Tumor objective response rate (ORR) defined as the sum of complete response (CR) and partial response (PR) as best reported by RECIST version 1.1.
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 38 months ]Number, type, incidence, duration, severity and seriousness of adverse events (AEs) as assessed by CTCAE v5.0
- Disease control rate (DCR) [ Time Frame: 38 months ]Disease control rate (DCR) defined as the sum of CR, PR and stable disease (SD) by RECIST version 1.1. - Progression Free Survival (PFS).
- Pharmacokinetic measures - Plasma concentration time Area Under the Curve [ Time Frame: 12 months ]Measure the variation of CHY33/olaparib concentration in blood plasma as a function of time
- Pharmacokinetic measures - Cmax [ Time Frame: 12 months ]Measure the maximum (peak) plasma concentration(s) of CHY33/olaparib
- Pharmacokinetic measures - Tmax [ Time Frame: 12 months ]Measure of time to reach maximum (peak) plasma concentration(s) following administration of CHY33/olaparib
- Pharmacokinetic measures - CL/F [ Time Frame: 12 months ]Measure apparent total clearance(s) of CHY33/olaparib from plasma after oral administration
- Pharmacokinetic measures - Vz/F [ Time Frame: 12 months ]Measure apparent volume of distribution during terminal phase after administration of CHY33/olaparib
- Pharmacokinetic measures - terminal half- life (t1/2) [ Time Frame: 12 months ]Measure elimination half-life of CHY33/olaparib, when administered in combination
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): NCT04586335
|Contact: Jason Sudia, PhD, MPHemail@example.com|
|Contact: Frank Tan, MD||Base GZ firstname.lastname@example.org|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Sandra Montez, RN 713-745-6274 email@example.com|
|Principal Investigator: Timothy Yap, MD|
|Integrated Oncology Network PTY LTD||Recruiting|
|Brisbane, Queensland, Australia, 4101|
|Contact: Jane Holt 61737374555 firstname.lastname@example.org|
|Principal Investigator: Jermaine Coward, MD|
|Study Director:||Joan Yu, MD||Haihe Biopharma|