A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic RCC

• Status: Terminated
• Trial end date: 2020-05-12
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

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