Trial Outcomes & Findings for PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma (NCT NCT01209598)
NCT ID: NCT01209598
Last Updated: 2017-11-06
Results Overview
PFS, defined as RECIST 1.1 (CR + PR + SD) when treated with Palbociclib
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-11-06
Participant Flow
Protocol Open to Accrual 09/23/2010 Protocol Closed to Accrual 05/27/2014 Primary Completion Date 10/25/2016 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Palbociclib 200mg
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.
Palbociclib 200mg: 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 125mg
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.
Palbociclib 125mg: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
60
|
|
Overall Study
COMPLETED
|
29
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Palbociclib 200mg
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.
Palbociclib 200mg: 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 125mg
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.
Palbociclib 125mg: 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
Baseline characteristics by cohort
| Measure |
Palbociclib 200mg
n=30 Participants
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.
Palbociclib 200mg: 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 125mg
n=60 Participants
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.
Palbociclib 125mg: 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.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
61.5 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
60 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPFS, defined as RECIST 1.1 (CR + PR + SD) when treated with Palbociclib
Outcome measures
| Measure |
Palbociclib 125mg
n=60 Participants
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.
Palbociclib 125mg: 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.
|
Palbociclib 200mg
n=30 Participants
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.
Palbociclib 200mg: 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.
|
|---|---|---|
|
Progression Free Survival at 12 Weeks
|
57.2 percentage of particpants
Interval 42.4 to 68.8
|
66 percentage of particpants
Interval 51.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 yearsPer 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
Outcome measures
| Measure |
Palbociclib 125mg
n=60 Participants
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.
Palbociclib 125mg: 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.
|
Palbociclib 200mg
n=30 Participants
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.
Palbociclib 200mg: 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.
|
|---|---|---|
|
Best Response
Non-Evaluable
|
1 Participants
|
1 Participants
|
|
Best Response
Partial Response
|
0 Participants
|
1 Participants
|
|
Best Response
Complete Response
|
1 Participants
|
0 Participants
|
|
Best Response
Stable Disease
|
8 Participants
|
5 Participants
|
|
Best Response
Progression of Disease
|
50 Participants
|
23 Participants
|
Adverse Events
Palbociclib 200mg
Serious events: 24 serious events
Other events: 30 other events
Deaths: 0 deaths
Palbociclib 125mg
Serious events: 55 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palbociclib 200mg
n=30 participants at risk
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.
Palbociclib 200mg: 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 125mg
n=60 participants at risk
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.
Palbociclib 125mg: 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.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
General disorders
Death NOS
|
3.3%
1/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.3%
1/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
3.3%
1/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
3.3%
1/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
General disorders
Fatigue
|
6.7%
2/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
5/30 • 2 years
|
21.7%
13/60 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
30.0%
9/30 • 2 years
|
31.7%
19/60 • 2 years
|
|
Investigations
Platelet count decreased
|
30.0%
9/30 • 2 years
|
6.7%
4/60 • 2 years
|
|
Investigations
White blood cell decreased
|
46.7%
14/30 • 2 years
|
25.0%
15/60 • 2 years
|
|
Investigations
Neutrophil count decreased
|
50.0%
15/30 • 2 years
|
36.7%
22/60 • 2 years
|
Other adverse events
| Measure |
Palbociclib 200mg
n=30 participants at risk
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.
Palbociclib 200mg: 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 125mg
n=60 participants at risk
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.
Palbociclib 125mg: 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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
2/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
2/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
General disorders
Edema limbs
|
6.7%
2/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
2/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
2/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
6.7%
2/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
General disorders
Fever
|
10.0%
3/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
4/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal & conn tissue disorder Other, spec
|
13.3%
4/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30 • 2 years
|
5.0%
3/60 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
5/30 • 2 years
|
0.00%
0/60 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
6/30 • 2 years
|
6.7%
4/60 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
26.7%
8/30 • 2 years
|
16.7%
10/60 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
30.0%
9/30 • 2 years
|
21.7%
13/60 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
30.0%
9/30 • 2 years
|
11.7%
7/60 • 2 years
|
|
General disorders
Fatigue
|
46.7%
14/30 • 2 years
|
25.0%
15/60 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
24/30 • 2 years
|
91.7%
55/60 • 2 years
|
|
Investigations
Platelet count decreased
|
83.3%
25/30 • 2 years
|
58.3%
35/60 • 2 years
|
|
Investigations
Neutrophil count decreased
|
86.7%
26/30 • 2 years
|
75.0%
45/60 • 2 years
|
|
Investigations
White blood cell decreased
|
93.3%
28/30 • 2 years
|
95.0%
57/60 • 2 years
|
Additional Information
Mark Dickson, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place