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This is a phase I, single-arm, single-center, open-label, dose-escalation Study evaluating the safety and efficacy of CT053PTSA in patients with Advanced Solid Tumors
This is a dose-escalation study. The primary purpose is to determine the dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommend doses and regimen of CT053PTSA for further studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT053PTSA (dose escalation) | Experimental | Patients were treated in 5 dose cohorts of 15 mg, 30 mg, 60 mg, 100 mg, and 150 mg QD capsules. Patients receive treatment with CT053PTSA once on Cycle 0 Day 1 following a 7-day treatment-free withdrawal period to observe the safety and pharmacokinetic of CT053PTSA. After that, Patients receive treatment with CT053PTSA per orally, beginning on Cycle 1 Day 1 for 28 day following a 7-day treatment-free withdrawal period to observe efficacy of CT053PTSA and determine to continue taking medicine or not. Each cycle had 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT053PTSA | Drug | CT053PTSA will be administered daily in fasting state |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | The maximum tolerated dose (MTD) of the CT053PTSA will be determined according to incidence of dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.0 | Cycle 0 Day 1 to Cycle 1 Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of CT053PTSA_Cmax | To evaluate the Pharmacokinetics (PK) of CT053PTSA with Maximum observed plasma concentration (Cmax) | Cycle 0 Day 1 to Cycle 1 Day 28 |
| Pharmacokinetics (PK) of CT053PTSA_Tmax |
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Inclusion Criteria:
- A. Subjects with advanced solid tumors confirmed by histologically or cytologically that are refractory to current treatment or for which there is not a current standard of care B. Toxicity recovered to NCI CTCAE v.4.0 Grade ≤1 from previous treatments (chemotherapy, radiotherapy or surgery) C. ECOG performance status (PS) 0 or 1 D. Life expectancy of ≥ 12 weeks E. Adequate organ function
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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To evaluate the Pharmacokinetics (PK) of CT053PTSA with Time of maximum observed plasma concentration (Tmax).
| Cycle 0 Day 1 to Cycle 1 Day 28 |
| Pharmacokinetics (PK) of CT053PTSA_AUC | To evaluate the Pharmacokinetics (PK) of CT053PTSA with Area under the plasma concentration time curve (AUC). | Cycle 0 Day 1 to Cycle 1 Day 28 |
| Efficacy of CT053PTSA_ORR | To assess overall response rate (ORR) for patients treated CT053PTSA. | up to approximately 36 months |
| Efficacy of CT053PTSA_DCR | To assess disease control rate (DCR) for patients treated CT053PTSA. | up to approximately 36 months |