SarcomaPhase 2NCT01209598
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
A Phase 2 study testing Palbociclib 200mg and Palbociclib 125mg in people with Sarcoma and Liposarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma. Palbociclib is an investigational drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Liposarcoma
- What is being tested?
- Palbociclib 200mg and Palbociclib 125mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2010to 25 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- A diagnosis of liposarcoma confirmed at MSKCC. Because myxoid / round cell liposarcoma does not have significant CDK4 amplification, patients with this subtype are not eligible.
- Metastatic and/or locally advanced or locally recurrent disease that is not surgically resectable, with evidence of disease progression, either clinically or radiographically, as determined by the investigator
- All patients must have measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >10 mm when measured by CT, MRI or caliper measurement by clinical exam; or >20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI.
- A minimum of 1 prior systemic regimen for recurrent/metastatic disease. Note: This requirement does not apply to patients enrolled in the Expansion Cohort. The last dose of systemic therapy (include targeted therapies) must have been given at least 2 weeks prior to initiation of therapy. Patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy.
- Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible.
- Age > or = 18 years.
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- ECOG performance status 0 or 1.
- Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):
- Absolute neutrophil count ≥ 1.5x109/L Hemoglobin ≥ 9.0 g/dL WBC ≥ 3.0x109/L Platelets ≥ 100x109/L Total bilirubin ≤ 1.5 x ULN except for patients with known Gilbert syndrome AST(SGOT)/ALT(SGPT) ≤ 3 x institutional ULN Serum creatinine ≤ 1.5 x ULN or Creatinine Clearance > 50 mL/min (calculated by Cockcroft-Gault method)QTc interval ≤ 470 msec
- Patients must not have current evidence of another malignancy that requires treatment.
- The effects of Palbociclib on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence). Women must not breast feed while on study.
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to swallow intact Palbociclib capsules.
- Patients" tumors must express Rb, as assessed using an historical biopsy sample if available or a newly obtained tumor sample. Samples must demonstrate ≥1+ staining for Rb. Patients' tumors must also have evidence of CDK4 amplification by FISH. Note: This does not apply to patients enrolled in the Expansion Cohort.
Who cannot join
- Patients who have not recovered from adverse events of prior therapy to ≤ NCI CTCAEv4.0 Grade 1.
- Patients receiving any other investigational agents.
- Patients who have received prior treatment with a selective CDK4 inhibitor
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Palbociclib.
- Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women and women who are breast-feeding.
- Patients with a history of long-QT syndrome or documented family history of long-QT syndrome. Patients who must remain on drugs that prolong the QT interval.
- Palbociclib is a substrate of CYP3A. Caution should be exercised when dosing Palbociclib concurrently with CYP3A inducers or inhibitors. Furthermore, patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4 should be switched to alternative medications to minimize any potential risk. A list of CYP3A4 substrates, inducers and/or inhibitors is provided in Appendix B. The following medications with strong potential for interaction are not allowed: indinavir nelfinavir ritonavir clarithromycin itraconazole ketoconazole nefazodone saquinavir telithromycin carbamazepine phenobarbital phenytoin pioglitazone rifabutin rifampin St. John's wort Troglitazone
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase II Study Of PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma.
Palbociclib is an investigational drug. An investigational drug is a medication that has not been approved for marketing by the Food and Drug Administration (FDA). Palbociclib blocks a protein called CDK4 which is part of a pathway in liposarcoma cells that is over-active. The investigators hope that blocking CDK4 will shut down this pathway in the liposarcoma cells and stop tumors from growing. Palbociclib is an oral medication.
- Conditions
- Sarcoma, Liposarcoma
- Being tested
- Palbociclib 200mg, Palbociclib 125mg
- Keywords
- soft tissue, Palbociclib (PD0332991), 10-094
- Medical subject headings
- Sarcoma, Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib 200mgDrug
Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days.
Palbociclib 125mgDrug
Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients.
Expansion Cohort: Dosed as per Schedule 3/1. Capsules should be taken with food.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib 200mg | Experimental | This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks. Receives: Drug: Palbociclib 200mg |
| Palbociclib 125mg | Experimental | This is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks. Receives: Drug: Palbociclib 125mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival at 12 Weeks
PFS, defined as RECIST 1.1 (CR + PR + SD) when treated with Palbociclib
Measured: 12 weeks
Secondary outcomes (1)
Best Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study start23 Sep 2010
- Primary completion25 Oct 2016
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Mark Dickson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209598
- Sponsor's protocol ID
- 10-094
- Status last verified
- Feb 2017
- First submitted
- 24 Sep 2010
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McAndrew NP, Dickson MA, Clark AS, Troxel AB, O'Hara MH, Colameco C, Gallager M, Gramlich K, Zafman K, Vaughn D, Schwartz GK, O'Dwyer PJ, DeMichele A. Early treatment-related neutropenia predicts response to palbociclib. Br J Cancer. 2020 Sep;123(6):912-918. doi: 10.1038/s41416-020-0967-7. Epub 2020 Jul 9.
PubMed 32641862Dickson MA, Schwartz GK, Keohan ML, D'Angelo SP, Gounder MM, Chi P, Antonescu CR, Landa J, Qin LX, Crago AM, Singer S, Koff A, Tap WD. Progression-Free Survival Among Patients With Well-Differentiated or Dedifferentiated Liposarcoma Treated With CDK4 Inhibitor Palbociclib: A Phase 2 Clinical Trial. JAMA Oncol. 2016 Jul 1;2(7):937-40. doi: 10.1001/jamaoncol.2016.0264.
PubMed 27124835Dickson MA, Tap WD, Keohan ML, D'Angelo SP, Gounder MM, Antonescu CR, Landa J, Qin LX, Rathbone DD, Condy MM, Ustoyev Y, Crago AM, Singer S, Schwartz GK. Phase II trial of the CDK4 inhibitor PD0332991 in patients with advanced CDK4-amplified well-differentiated or dedifferentiated liposarcoma. J Clin Oncol. 2013 Jun 1;31(16):2024-8. doi: 10.1200/JCO.2012.46.5476. Epub 2013 Apr 8.
PubMed 23569312
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
- ClinicalTrials.gov ID
- NCT01209598
- Acronym / sponsor ID
- 10-094
- Conditions
- Sarcoma, Liposarcoma
- Keywords
- soft tissue, Palbociclib (PD0332991), 10-094
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 23 Sep 2010 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 27 Sep 2010 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma.
Palbociclib is an investigational drug. An investigational drug is a medication that has not been approved for marketing by the Food and Drug Administration (FDA). Palbociclib blocks a protein called CDK4 which is part of a pathway in liposarcoma cells that is over-active. The investigators hope that blocking CDK4 will shut down this pathway in the liposarcoma cells and stop tumors from growing. Palbociclib is an oral medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palbociclib 200mg | Experimental | Drug: Palbociclib 200mgThis is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks. |
| Palbociclib 125mg | Experimental | Drug: Palbociclib 125mgThis is a phase II study of Palbociclib in patients with advanced / metastatic liposarcoma. A one-stage design is used to determine whether patients treated with Palbociclib achieved a PFS rate of ≥ 40% at 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A diagnosis of liposarcoma confirmed at MSKCC. Because myxoid / round cell liposarcoma does not have significant CDK4 amplification, patients with this subtype are not eligible.
- Metastatic and/or locally advanced or locally recurrent disease that is not surgically resectable, with evidence of disease progression, either clinically or radiographically, as determined by the investigator
- All patients must have measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >10 mm when measured by CT, MRI or caliper measurement by clinical exam; or >20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI.
- A minimum of 1 prior systemic regimen for recurrent/metastatic disease. Note: This requirement does not apply to patients enrolled in the Expansion Cohort. The last dose of systemic therapy (include targeted therapies) must have been given at least 2 weeks prior to initiation of therapy. Patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy.
- Patients with brain metastasis that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible.
Key exclusion criteria (8 listed)
- Patients who have not recovered from adverse events of prior therapy to ≤ NCI CTCAEv4.0 Grade 1.
- Patients receiving any other investigational agents.
- Patients who have received prior treatment with a selective CDK4 inhibitor
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Palbociclib.
- Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Palbociclib 200mgSchedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days. | Drug | Palbociclib 200mg |
| Palbociclib 125mgSchedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients. Expansion Cohort: Dosed as per Schedule 3/1. Capsules should be taken with food. | Drug | Palbociclib 125mg |
Primary outcome
Progression Free Survival at 12 Weeks
Time frame: 12 weeks
PFS, defined as RECIST 1.1 (CR + PR + SD) when treated with Palbociclib
1 secondary outcome
Best Response
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32641862McAndrew NP, Dickson MA, Clark AS, Troxel AB, O'Hara MH, Colameco C, Gallager M, Gramlich K, Zafman K, Vaughn D, Schwartz GK, O'Dwyer PJ, DeMichele A. Early treatment-related neutropenia predicts response to palbociclib. Br J Cancer. 2020 Sep;123(6):912-918. doi: 10.1038/s41416-020-0967-7. Epub 2020 Jul 9.
- Derived from this study: PubMed 27124835Dickson MA, Schwartz GK, Keohan ML, D'Angelo SP, Gounder MM, Chi P, Antonescu CR, Landa J, Qin LX, Crago AM, Singer S, Koff A, Tap WD. Progression-Free Survival Among Patients With Well-Differentiated or Dedifferentiated Liposarcoma Treated With CDK4 Inhibitor Palbociclib: A Phase 2 Clinical Trial. JAMA Oncol. 2016 Jul 1;2(7):937-40. doi: 10.1001/jamaoncol.2016.0264.
- Derived from this study: PubMed 23569312Dickson MA, Tap WD, Keohan ML, D'Angelo SP, Gounder MM, Antonescu CR, Landa J, Qin LX, Rathbone DD, Condy MM, Ustoyev Y, Crago AM, Singer S, Schwartz GK. Phase II trial of the CDK4 inhibitor PD0332991 in patients with advanced CDK4-amplified well-differentiated or dedifferentiated liposarcoma. J Clin Oncol. 2013 Jun 1;31(16):2024-8. doi: 10.1200/JCO.2012.46.5476. Epub 2013 Apr 8.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Mark Dickson, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 200mg and Palbociclib 125mg in people with Sarcoma and Liposarcoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 6 Nov 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival at 12 Weeks (time frame: 12 weeks). 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 NCT01209598, which also lists 3 linked publications.
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 Nov 2017.