Thymic CancerPhase 2NCT03219554
A Phase II Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumor
A Phase 2 study testing Palbociclib in people with Thymic Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a phase II single center, open-label, single arm study of palbociclib treatment in patients with recurrent or metastatic advanced TETs after failure of one or more cytotoxic chemotherapy regimens. Patients will receive oral palbociclib 125mg daily for 21days followed by a 7-day break. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymic Cancer
- What is being tested?
- Palbociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2017to Dec 2020
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven thymic epithelial tumor (TET) patients
- Be ≥18 years of age on day of signing informed consent.
- Documented progressive disease according to RECIST v1.1 following receipt of at least one cytotoxic chemotherapy regimen administered for inoperable or metastatic disease.
- Measurable disease as defined per RECIST v 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated sited after completion of therapy is clearly documented.
- Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 10 unstained slides]), which will be used for retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
- ECOG performance status of 0 to 2
Who cannot join
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
- Inability to swallow capsules.
- Prior treatment with any CDK4/6 inhibitor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Samsung Medical Center
This is a phase II single center, open-label, single arm study of palbociclib treatment in patients with recurrent or metastatic advanced TETs after failure of one or more cytotoxic chemotherapy regimens. Patients will receive oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
Read the detailed description
Patients will continue to receive Palbociclib until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever occurs first.
Disease assessments will be performed every 8 weeks (±7 days) from the date of initiation of treatment. Each assessment will be performed as scheduled according to the calendar regardless of any dosing delay to prevent the introduction of bias into the assessment of efficacy. Tumor assessments will be performed until radiographically and/or clinically (ie, for photographed or palpable lesions) documented progressive disease (PD) as per RECIST v.1.1, initiation of new anticancer therapy, or discontinuation of patient from overall study participation (eg, death, patient's request, lost to follow-up), whichever occurs first.
- Conditions
- Thymic Cancer
- Being tested
- Palbociclib
- Medical subject headings
- Thymus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| palbociclib | Experimental | oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days. Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival ( PFS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung-Ju Ahn, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219554
- Sponsor's protocol ID
- 2016-12-006
- Status last verified
- Aug 2017
- First submitted
- 13 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Samsung Medical Center
- ClinicalTrials.gov ID
- NCT03219554
- Acronym / sponsor ID
- 2016-12-006
- Conditions
- Thymic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II single center, open-label, single arm study of palbociclib treatment in patients with recurrent or metastatic advanced TETs after failure of one or more cytotoxic chemotherapy regimens. Patients will receive oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
Detailed description
Patients will continue to receive Palbociclib until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawn of consent, whichever occurs first.
Disease assessments will be performed every 8 weeks (±7 days) from the date of initiation of treatment. Each assessment will be performed as scheduled according to the calendar regardless of any dosing delay to prevent the introduction of bias into the assessment of efficacy. Tumor assessments will be performed until radiographically and/or clinically (ie, for photographed or palpable lesions) documented progressive disease (PD) as per RECIST v.1.1, initiation of new anticancer therapy, or discontinuation of patient from overall study participation (eg, death, patient's request, lost to follow-up), whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| palbociclib | Experimental | Drug: Palbocicliboral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven thymic epithelial tumor (TET) patients
- Be ≥18 years of age on day of signing informed consent.
- Documented progressive disease according to RECIST v1.1 following receipt of at least one cytotoxic chemotherapy regimen administered for inoperable or metastatic disease.
- Measurable disease as defined per RECIST v 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated sited after completion of therapy is clearly documented.
- Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 10 unstained slides]), which will be used for retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.
Key exclusion criteria (3 listed)
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.
- Inability to swallow capsules.
- Prior treatment with any CDK4/6 inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palbocicliboral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days. | Drug | palbociclib |
Primary outcome
Progression-free survival ( PFS)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palbociclib in people with Thymic Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Aug 2017. 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 South Korea. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact myung-ju ahn, M.D. Ph.D (82-2-3410-3459, silk.ahn@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival ( PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2017.