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

NCT03876925 | Terminated Phase 1

• 1 other identifier: PCD-DCT053-17-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Cell Cancer Metastatic

Keywords

RCC

Outcome Measures

Primary Outcomes (2)

• Part 1(dose-escalation part):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 CTCAEv4.03

  Cycle 1 Day 1 to Cycle 1 Day 28

• Part 2 (expansion part):Overall Response Rate

  Overall response rate (ORR),defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST1.1

  up to approximately 24 months

Secondary Outcomes (8)

• Number of patients with adverse events (AEs) as a measure of safety and tolerability

  up to approximately 24 months

• Disease Control Rate (DCR)

  up to approximately 24 months

• Progression-free Survival (PFS)

  up to approximately 24 months

• Duration of Response (DOR)

  up to approximately 24 months

• Overall Survival (OS)

  up to approximately 24 months

Study Arms (1)

CT053PTSA

EXPERIMENTAL

60-100mg

Drug: CT053PTSA

Interventions

CT053PTSA DRUG

Patients will received oral CT053PTSA once daily until disease progression or intolerable toxicity or subject's withdrawal from treatment ,each cycle is defined as 28 days

Also known as: Ningetinib

CT053PTSA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Study Officials

• Guo Jun, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 15, 2019
• Study Start: June 25, 2018
• Primary Completion: March 1, 2020
• Study Completion: May 12, 2020
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)