Clinical trial NCT03876925: A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic RCC
Official title: A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Renal Cell Cancer Metastatic
Keywords: RCC
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase Ib,single arm,open label study evaluating the safety and efficacy of CT053PTSA in patients with advanced and metastatic renal cell cancer who have progressed from previous treatment

Detailed description: This study is being carried out in two parts,part 1 and part 2. Part 1: This is the dose-escalation part. The primary purpose of the part 1 portion is to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), and recommend the appropriate doses of CT053PTSA for further study Part 2: This is the expansion part.The part 2 portion of this study will continue to evaluate the safety and efficacy of CT053PTSA at the appropriate dose recommended in Part 1,in patients with advanced and metastatic RCC

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed renal cell cancer.Patients must be diagnosed with advanced or metastatic disease,disease progressed to previous treatment .
* Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Toxicity recovered to NCI CTCAE v.4.03 Grade ≤1 from previous treatments (except alopecia)
* ECOG performance status (PS) 0 or 1
* Life expectancy of ≥ 12 weeks
* Adequate organ function
* Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion Criteria:

* Chemotherapy,radiotherapy,immunotherapy and targeted therapy less than 4 months prior to administration.
* Symptomatic, untreated or unstable central nervous system metastases
* Uncontrolled hypertension that require anti-hypertensive agents to control, or systolic blood pressure (BP) \>140mmHg or diastolic BP \>90 mmHg before the first administration (BP is the mean blood pressure of two measures that 1 hours interval or above)
* Doppler ultrasound evaluation：Left ventricular ejection fraction \< 50%
* Significantly clinical arrhythmia or symptomatic bradycardia, or male with QTCF \> 450 ms or female with QTCF \> 470 ms, or patients with a history of torsion or congenital QT prolonged syndrome long QT syndrome
* Certain factors that would preclude adequate absorption of CT053PTSA and gefitinib (eg. unable to swallow, chronic diarrhea, intestinal obstruction)
* Patients with evidence of bleeding tendency, including the following cases: gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above; or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator
* History of organ transplantation
* Any disease of the following bellowed within 12 months prior to administration: Myocardial infarction, severe angina, or unstable angina, coronary or peripheral artery bypass graft, congestive heart failure
* Pulmonary embolism or cerebrovascular events (including transient ischemic attack)within 6 months prior to administration
* Infection of HIV
* Patients with infection of HBV or HCV. Patients with positive of HBsAg or HBcAb,and HBV-DNA can be measured (\>500IU/ml). Patients with positive of anti-HCV,and HCV-RNA can be measured by PCR.
* Other malignancies within 5 years prior to enrollment, with the exception of carcinoma in situ of the cervix, basal or squamous cell skin cancer
* Pregnant or lactating woman
* Any other reason the investigator considers the patient is not suitable to participate in the study

Primary outcomes:
measure: Part 1(dose-escalation part):Maximum Tolerated Dose (MTD)
timeFrame: Cycle 1 Day 1 to Cycle 1 Day 28
measure: Part 2 (expansion part):Overall Response Rate
timeFrame: up to approximately 24 months
Secondary outcomes:
measure: Number of patients with adverse events (AEs) as a measure of safety and tolerability
timeFrame: up to approximately 24 months
measure: Disease Control Rate (DCR)
timeFrame: up to approximately 24 months
measure: Progression-free Survival (PFS)
timeFrame: up to approximately 24 months
measure: Duration of Response (DOR)
timeFrame: up to approximately 24 months
measure: Overall Survival (OS)
timeFrame: up to approximately 24 months
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Cycle 1 Day1 and Day 28
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Cycle 1 Day1 and Day 28
measure: Area under the plasma concentration time curve (AUC)
timeFrame: Cycle 1 Day1 and Day 28
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Guo Jun, PhD
role: PRINCIPAL_INVESTIGATOR
References: