A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03952078|
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : June 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|T-cell Lymphoma||Drug: CPI-818||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||151 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma|
|Actual Study Start Date :||May 3, 2019|
|Estimated Primary Completion Date :||April 30, 2026|
|Estimated Study Completion Date :||April 30, 2026|
Experimental: CPI-818 Dose Escalation
Participants will receive CPI-818 capsule, orally, twice per day at an assigned dose, till disease progression, complete response or remission (CR) for >2 months or if dose determined to be unsafe.
Interleukin-2 inducible T-cell Kinase Inhibitor
Experimental: CPI-818 Dose Expansion phase
Participants with different T-cell lymphoma sub-types will receive CPI-818 capsules at the specific dose selected from the Dose escalation phase of the study.
CPI-818 capsules at the selected dose will be taken orally, twice per day until disease progression or CR for > 2 months.
Interleukin-2 inducible T-cell Kinase Inhibitor
- Incidence, nature, and severity of adverse events following treatment with CPI 818 to establish the safety and tolerability with increasing dose [ Time Frame: First dose until 30 days after treatment stop ]
- Incidence and nature of dose limiting toxicities (DLTs) of CPI 818 to establish either the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of CPI 818 [ Time Frame: Up to approximately 21 days after first dose ]
- Area under the curve (AUC) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818 [ Time Frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days. ]
- Maximum serum concentration (Cmax) of CPI-818 in blood samples to evaluate the pharmacokinetic profile of CPI 818 [ Time Frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days. ]
- Objective response rate per Laguno Classification for CTCL and Consensus Statement for Response for CTCL to assess the anti-tumor activity of CPI 818 in subjects with R/R T cell lymphoma [ Time Frame: From start of treatment through end of study treatment, up to approximately 24 months ]
- Evaluate total percentage of tumor gene expression in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment. [ Time Frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days. ]
- Evaluate overall percentage of malignant cells in post-treatment blood and tumor samples to evaluate pharmacodynamic changes with treatment. [ Time Frame: Day 1, 2, 8, 15 of Cycle 1, Day 1 and 2 of Cycle 3, and Day 1 for all even number Cycles. Each Cycle is 21 days. ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adult subjects age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed evidence of T-cell lymphoma
- Measurable disease.
- Adequate organ function.
- At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.
- Treatment with systemic immunosuppressive medication.
- History of allogeneic hematopoietic stem cell transplantation.
- History of primary immunodeficiency, solid organ transplantation.
- History of opportunistic infection within 180 days of starting study drug.
- Females who are pregnant, lactating, or intend to become pregnant
- History of invasive prior malignancy that required systemic therapy within last 3 years.
- Concomitant use of strong inhibitors or inducers of CYP3A.
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): NCT03952078
|Contact: Director Clinical Operationsemail@example.com|
|Study Director:||Suresh Mahabhashyam, MD, MPH||Corvus Pharmaceuticals|
|Responsible Party:||Corvus Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 16, 2019 Key Record Dates|
|Last Update Posted:||June 22, 2022|
|Last Verified:||June 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Immune System Diseases