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

Primary Purpose

Renal Cell Cancer Metastatic

Status

Terminated

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CT053PTSA

About this trial

This is an interventional treatment trial for Renal Cell Cancer Metastatic focused on measuring RCC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT053PTSA

Arm Description

60-100mg

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Safety and tolerability will be assessed through AEs, via monitoring changes in physical examination, clinical laboratory parameters, vital signs and ECGs

Disease Control Rate (DCR)

DCR, proportion of patients with best overall response of CR, PR or SD

Progression-free Survival (PFS)

PFS, defined as time from date of treatment to disease progression or death due to any cause

Duration of Response (DOR)

DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause

Overall Survival (OS)

OS, defined as time from date of treatment to death due to any cause

Maximum observed plasma concentration (Cmax)

to assess the pharmacokinetic profile

Time of maximum observed plasma concentration (Tmax)

to assess the pharmacokinetic profile

Area under the plasma concentration time curve (AUC)

to assess the pharmacokinetic profile

Full Information

NCT ID

NCT03876925

First Posted

March 14, 2019

Last Updated

March 22, 2021

Sponsor

Sunshine Lake Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03876925

Brief Title

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

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

The effect of CT053PTSA in preciously treated patients with advanced and metastatic RCC is not as good as pre-expected

Study Start Date

June 25, 2018 (Actual)

Primary Completion Date

March 1, 2020 (Actual)

Study Completion Date

May 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Cancer Metastatic

Keywords

RCC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CT053PTSA

Arm Type

Experimental

Arm Description

60-100mg

Intervention Type

Drug

Intervention Name(s)

CT053PTSA

Other Intervention Name(s)

Ningetinib

Intervention Description

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

Primary Outcome Measure Information:

Title

Part 1(dose-escalation part):Maximum Tolerated Dose (MTD)

Description

The maximum tolerated dose (MTD) of the CT053PTSA will be determined according to incidence of dose-limiting toxicity (DLT) assessed by NCI CTCAEv4.03

Time Frame

Cycle 1 Day 1 to Cycle 1 Day 28

Title

Part 2 (expansion part):Overall Response Rate

Description

Time Frame

up to approximately 24 months

Secondary Outcome Measure Information:

Title

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

Description

Safety and tolerability will be assessed through AEs, via monitoring changes in physical examination, clinical laboratory parameters, vital signs and ECGs

Time Frame

up to approximately 24 months

Title

Disease Control Rate (DCR)

Description

DCR, proportion of patients with best overall response of CR, PR or SD

Time Frame

up to approximately 24 months

Title

Progression-free Survival (PFS)

Description

PFS, defined as time from date of treatment to disease progression or death due to any cause

Time Frame

up to approximately 24 months

Title

Duration of Response (DOR)

Description

DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause

Time Frame

up to approximately 24 months

Title

Overall Survival (OS)

Description

OS, defined as time from date of treatment to death due to any cause

Time Frame

up to approximately 24 months

Title

Maximum observed plasma concentration (Cmax)

Description

to assess the pharmacokinetic profile

Time Frame

Cycle 1 Day1 and Day 28

Title

Time of maximum observed plasma concentration (Tmax)

Description

to assess the pharmacokinetic profile

Time Frame

Cycle 1 Day1 and Day 28

Title

Area under the plasma concentration time curve (AUC)

Description

to assess the pharmacokinetic profile

Time Frame

Cycle 1 Day1 and Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guo Jun, PhD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hospital

City

Beijing

State/Province

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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