MelanomaPhase 2NCT03454919
Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations
A Phase 2 study testing Palbociclib in people with Melanoma, run by Peking University Cancer Hospital & Institute.
Trial summary
It is a prospective, phase II, open-labeled, clinical trial aimed to determine the efficacy of palbociclib in advanced melanoma patients who bear gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss]. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Palbociclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2018to 30 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years;
- ECOG performance status 0 or 1 before treatment;
- Metastatic melanoma or unresectable acral melanoma;
- Histologically confirmed melanoma.
- Bearing gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss].;
- Anticipated life expectancy ≥ 3 month;
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- Adequate organ function, defined as following criteria:
- Platelets 75 x 109/L, Hemoglobin 9.0 g/dL, Absolute Neutrophils(ANC) ≥ 1.5x109/L;
- Serum bilirubin ≤ 1.5*upper limit of normal (ULN) (could be ignored in the case of Gilbert's syndrome) ，Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 1.5 * ULN;
- Blood urea nitrogen (BUN) ≤ 1.5 * ULN, serum creatinine (Cr) ≤ 1.5 * ULN.
- Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) as assessed by multigated acquisition (MUGA) scan or echocardiography;
- QTc interval: male < 450msec, female < 470msec (via Fridericia method)
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Written informed consent signed.
Who cannot join
- Previous or current administration of any kind of CDK4/6 inhibitors;
- Administration of any other anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, endocrinal therapy, surgery, molecular targeted therapy, immunotherapy or biological therapy) 4 weeks before inclusion; administration of mitocycin or nitrosamines 8 weeks before inclusion;
- Non-treated brain metastasis (treatment controlled stable brain metastasis judged by investigators excluded);
- Presence of third space fluid that cannot be controlled by drainage or other means (i.e. pleural effusion or ascites);
- Long-term steroid therapy required;
- Uncorrectable hypokalemia or hypomagnesaemia before inclusion;
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- Concurrent administration of drugs with potential of QT interval prolongation (such as antiarrhythmic drugs);
- Allergies or previous history of severe allergies;
- Active HBV or HCV infection (HBV viral copy number ≥ 104 copies/ml, HCV ≥ 103 copies/ml);
- NCICTCAE Grade 2 toxicity before inclusion;
- Diagnosed as any second primary malignant tumor in 5 years before inclusion;
- Following conditions occur in the 6 months before drug administration: severe/ unstable angina pectoris, myocardial infarction, congestive heart failure with symptoms, cerebrovascular accident, including transient ischemic attack, pulmonary embolism, ≥ grade II renal dysfunction, and other severe diseases that investigators judged to be unsuitable for this trial;
- Administration of potent CYP3A4 inhibitors in 7 days before inclusion , or administration of potent CYP3A4 inhibitors in 12 days before randomization ；
- NCICTCAE Grade ≥ 2 Active arrhythmias;
- Hypertension, defined as systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg，and cannot be controlled by medication;
- No recommendation to receive >2 mg Warfarin treatment in 2 weeks before study beginning. It is permitted to use low dose Warfarin(<2 mg／3day) to prevent deep venous thrombosis. Low molecular weight heparin (fractionated) or aspirin are also allowed;
- Existence of any disease affecting drug absorption, including but not limited to: no ability to swallow oral medications, active inflammatory bowel disease, partial or complete obstruction, partial or total gastrectomy, extensive bowel resection or chronic diarrhea;
- Known infection of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or congenital immune deficiency diseases, organ transplantation history;
- Pregnancy, breastfeeding, childbearing age female who is reluctant to take effective contraceptive measures throughout trial period. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days before randomization and at first day of every cycle on visit.
- Other severe acute or chronic physiological or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Current treatment on another clinical trial. Supportive care or non-therapeutic clinical trials are allowed.
About this study
Official title: A Phase II Clinical Study on Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations
It is a prospective, phase II, open-labeled, clinical trial aimed to determine the efficacy of palbociclib in advanced melanoma patients who bear gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss]. Fifteen patients, if there is a response then further 45 patients will be enrolled. Totally 60 subjects with known above-mentioned gene aberrations who comply with the inclusion and exclusion criteria will be enrolled, their serum samples (at the time of the first administration of palbociclib and every 4 weeks afterwards) will be collected. Palbociclib will be given in the dose of 125 mg orally qd d1-21 every 28 days, unless disease progression or intolerance. All patients will be evaluated for the response to palbociclib by Response Evaluation Criteria in Solid Tumors (RECIST) at baseline. The standard radiographic imaging (CT scans) will be performed every 4 weeks until the end of treatment.
Read the detailed description
This study is to evaluate efficacy of palbociclib in advanced acral melanoma patients with gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss].
- Conditions
- Melanoma
- Being tested
- Palbociclib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called ibrance
Drug: palbociclib; ibrance; Pfizer Inc，New York，NY Schedule: Recommended initial dosage 125mg/d，3 weeks on, 1 week off. If grade 3 or 4 adverse events occur during treatment，dosage could be reduced to 100mg/d, even 75mg/d.
Duration: till disease progression or drug intolerance.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib | Other | single arm Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
complete and partial response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (3)
PFS
Progression free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
6-month PFS rate
6-month PFS rate
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
AE
adverse events
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start30 Mar 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kiang Wu Hospital
- Responsible party
- Principal investigator, Jun Guo, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454919
- Sponsor's protocol ID
- 2017-003
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2018
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mao L, Dai J, Cao Y, Bai X, Sheng X, Chi Z, Cui C, Kong Y, Zhang Y, Wu L, Wang X, Tang B, Lian B, Yan X, Li S, Zhou L, Wei X, Li C, Qi Z, Si L, Guo J. Palbociclib in advanced acral melanoma with genetic aberrations in the cyclin-dependent kinase 4 pathway. Eur J Cancer. 2021 May;148:297-306. doi: 10.1016/j.ejca.2021.02.021. Epub 2021 Mar 23.
PubMed 33770575
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study on Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations
- ClinicalTrials.gov ID
- NCT03454919
- Acronym / sponsor ID
- 2017-003
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Kiang Wu Hospital
- Study start
- 30 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 6 Mar 2018 (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.
It is a prospective, phase II, open-labeled, clinical trial aimed to determine the efficacy of palbociclib in advanced melanoma patients who bear gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss]. Fifteen patients, if there is a response then further 45 patients will be enrolled. Totally 60 subjects with known above-mentioned gene aberrations who comply with the inclusion and exclusion criteria will be enrolled, their serum samples (at the time of the first administration of palbociclib and every 4 weeks afterwards) will be collected. Palbociclib will be given in the dose of 125 mg orally qd d1-21 every 28 days, unless disease progression or intolerance. All patients will be evaluated for the response to palbociclib by Response Evaluation Criteria in Solid Tumors (RECIST) at baseline. The standard radiographic imaging (CT scans) will be performed every 4 weeks until the end of treatment.
Detailed description
This study is to evaluate efficacy of palbociclib in advanced acral melanoma patients with gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss].
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib | Other | Drug: Palbociclibsingle arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age from 18 to 75 years;
- ECOG performance status 0 or 1 before treatment;
- Metastatic melanoma or unresectable acral melanoma;
- Histologically confirmed melanoma.
- Bearing gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss].;
Key exclusion criteria (21 listed)
- Previous or current administration of any kind of CDK4/6 inhibitors;
- Administration of any other anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, endocrinal therapy, surgery, molecular targeted therapy, immunotherapy or biological therapy) 4 weeks before inclusion; administration of mitocycin or nitrosamines 8 weeks before inclusion;
- Non-treated brain metastasis (treatment controlled stable brain metastasis judged by investigators excluded);
- Presence of third space fluid that cannot be controlled by drainage or other means (i.e. pleural effusion or ascites);
- Long-term steroid therapy required;
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 |
|---|---|---|
| PalbociclibAlso: ibranceDrug: palbociclib; ibrance; Pfizer Inc，New York，NY Schedule: Recommended initial dosage 125mg/d，3 weeks on, 1 week off. If grade 3 or 4 adverse events occur during treatment，dosage could be reduced to 100mg/d, even 75mg/d. Duration: till disease progression or drug intolerance. | Drug | Palbociclib |
Primary outcome
Overall response rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
complete and partial response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
3 secondary outcomes
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
6-month PFS rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
AE
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Derived from this study: PubMed 33770575Mao L, Dai J, Cao Y, Bai X, Sheng X, Chi Z, Cui C, Kong Y, Zhang Y, Wu L, Wang X, Tang B, Lian B, Yan X, Li S, Zhou L, Wei X, Li C, Qi Z, Si L, Guo J. Palbociclib in advanced acral melanoma with genetic aberrations in the cyclin-dependent kinase 4 pathway. Eur J Cancer. 2021 May;148:297-306. doi: 10.1016/j.ejca.2021.02.021. Epub 2021 Mar 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palbociclib in people with Melanoma, run by Peking University Cancer Hospital & Institute.
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 14 inclusion and 21 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 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Overall response rate (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). 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 NCT03454919, which also lists 1 linked publication.
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 6 Mar 2018.