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Renal Cell Cancer MetastaticPhase 1/2NCT03876925

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

A Phase 1/2 study testing CT053PTSA in people with Renal Cell Cancer Metastatic, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Renal Cell Cancer Metastatic
What is being tested?
CT053PTSA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
25 Jun 2018to 12 May 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic Renal Cell Cancer

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

Read the 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

Being tested
CT053PTSA
Keywords
RCC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT053PTSADrug

    Also called Ningetinib

    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

Study groups in NCT03876925
Study groupRoleWhat they receive
CT053PTSAExperimental60-100mg
Receives: Drug: CT053PTSA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Cycle 1 Day 1 to Cycle 1 Day 28

  2. 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

    Measured: up to approximately 24 months

Secondary outcomes (8)

  1. 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

    Measured: up to approximately 24 months

  2. Disease Control Rate (DCR)

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

    Measured: up to approximately 24 months

  3. Progression-free Survival (PFS)

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

    Measured: up to approximately 24 months

  4. 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

    Measured: up to approximately 24 months

  5. Overall Survival (OS)

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

    Measured: up to approximately 24 months

  6. Maximum observed plasma concentration (Cmax)

    to assess the pharmacokinetic profile

    Measured: Cycle 1 Day1 and Day 28

  7. Time of maximum observed plasma concentration (Tmax)

    to assess the pharmacokinetic profile

    Measured: Cycle 1 Day1 and Day 28

  8. Area under the plasma concentration time curve (AUC)

    to assess the pharmacokinetic profile

    Measured: Cycle 1 Day1 and Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2019
  2. Study start25 Jun 2018
  3. Primary completion1 Mar 2020
  4. Study completion12 May 2020

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03876925
Sponsor's protocol ID
PCD-DCT053-17-001
Status last verified
Mar 2021
First submitted
14 Mar 2019
Last updated
24 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CT053PTSA in people with Renal Cell Cancer Metastatic, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The effect of CT053PTSA in preciously treated patients with advanced and metastatic RCC is not as good as pre-expected). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1(dose-escalation part):Maximum Tolerated Dose (MTD) (time frame: Cycle 1 Day 1 to Cycle 1 Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03876925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.

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