March 27, 2014
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April 1, 2014
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April 15, 2021
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June 11, 2021
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December 21, 2023
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June 17, 2014
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June 8, 2020 (Final data collection date for primary outcome measure)
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- Phase I - Maximum Tolerated Dose (MTD) [ Time Frame: 6 months (estimated completion of Phase I) ]
MTD is the dose level (DL) immediately below the DL at which 2 patients of a cohort experience dose limiting toxicity (DLT) in the 1st cycle (DLTs) Hematologic DLT is any of the below that occur during the 1st cycle that are possibly, probably, or definitely related to the treatment grade 4 neutropenia ≥7 days grade 4 infection with grade 3/4 neutropenia grade 4 thrombocytopenia with life-threatening bleeding treatment held for >14 days due to hematologic toxicity febrile neutropenia with temperature >=38.5°C
Non-hematologic DLT is any possibly, probably, or definitely related grade 3 or 4 non-hematologic toxicity that occurs during the 1st except for suboptimally treated grade 3 or 4 nausea, vomiting, diarrhea, anorexia, or lymphopenia grade 3 metabolic abnormalities (limited to potassium, magnesium, and calcium) any hypersensitivity/infusion reaction or acneiform rash due to cetuximab treatment held for >14 days due to non-hematologic toxicity
- Phase II: Efficacy as Measured by Overall Response Rate [ Time Frame: End of treatment (estimated to be 12 months) ]
Tumor measurements will be collected at baseline, end of every even numbered cycles, and end of treatment.
Measured by overall response rate (ORR=CR+PR) defined by RECIST criteria
Best overall response is the best response recorded from the start of treatment until disease progression/recurrence
Complete Response (CR) is defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).
Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
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- Phase I-MTD [ Time Frame: 26 months ]
MTD is the dose level immediately below the dose level at which 2 patients of a cohort experience DLT during the first cycle
Dose Limiting Toxicities (DLTs) Hematologic DLT is defined as any of the following that occur during the first cycle that are attributed as possibly, probably, or definitely related to the treatment grade 4 neutropenia ≥7 day duration grade 4 infection with grade 3 or 4 neutropenia grade 4 thrombocytopenia associated with life-threatening bleeding treatment held for >14 days due to hematologic toxicity febrile neutropenia of any duration with temperature >38.5°C
Non-hematologic DLT is defined as any possibly, probably, or definitely related grade 3 or 4 non-hematologic toxicity that occurs during the first cycle with the following specific exceptions suboptimally treated grade 3 or 4 nausea, vomiting, diarrhea, anorexia, or lymphopenia grade 3 metabolic abnormalities any hypersensitivity / infusion reaction or acneiform rash due to cetuximab
- Phase II Efficacy of PD 0332991 and cetuximab [ Time Frame: 92 months ]
Measured by overall response rate (ORR=CR+PR) defined by RECIST criteria and by time to progression (TTP).
Complete Response (CR) is defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).
Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
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- Phase I: Most Frequent Adverse Events [ Time Frame: Up to 30 days following completion of treatment (estimated to be 13 months) ]
Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events [ Time Frame: Up to 30 days following completion of treatment (estimated to be 13 months) ]
Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Phase II: Cetuximab Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events [ Time Frame: Up to 30 days following completion of treatment (estimated to be 13 months) ]
Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events [ Time Frame: Up to 30 days following completion of treatment (estimated to be 13 months) ]
Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Phase II: Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
Participants were followed every 2 months for up to 5 years or until death, whichever occurs first.
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- Phase II: Overall Survival (OS) [ Time Frame: Up to 5 years ]
Participants were followed every 2 months for up to 5 years or until death, whichever occurs first.
Overall survival is measured from time of diagnosis to time of death.
- Phase II: Duration of Response [ Time Frame: Completion of treatment (estimated to be 12 months) ]
Duration of overall response is measured from the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented.
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- Adverse events [ Time Frame: 26 months ]
Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Progression free survival (PFS) [ Time Frame: 92 months ]
Duration of time from start of treatment to time of progression or death, whichever occurs first.
- Overall survival (OS) [ Time Frame: 92 months ]
Time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.
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Not Provided
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Not Provided
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PD 0332991 and Cetuximab in Patients With Incurable SCCHN
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Phase I/II Trial of the Addition of PD 0332991 to Cetuximab in Patients With Incurable SCCHN
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The purpose of this Phase I/II study is to define the maximum tolerated dose of PD 0332991 given with cetuximab and evaluated the side effects of the combination.
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Not Provided
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Interventional
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Phase 1 Phase 2
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Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment
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Carcinoma, Squamous Cell of Head and Neck
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- Biological: Cetuximab
Other Name: Erbitux®
- Drug: PD 0332991
Other Name: palbociclib
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- Experimental: Phase I: Dose Level 1
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Interventions:
- Biological: Cetuximab
- Drug: PD 0332991
- Experimental: Phase I: Dose Level 2
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Interventions:
- Biological: Cetuximab
- Drug: PD 0332991
- Experimental: Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Interventions:
- Biological: Cetuximab
- Drug: PD 0332991
- Experimental: Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Interventions:
- Biological: Cetuximab
- Drug: PD 0332991
- Experimental: Phase II Arm 3:
PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.
Interventions:
- Biological: Cetuximab
- Drug: PD 0332991
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Adkins D, Ley J, Neupane P, Worden F, Sacco AG, Palka K, Grilley-Olson JE, Maggiore R, Salama NN, Trinkaus K, Van Tine BA, Steuer CE, Saba NF, Oppelt P. Palbociclib and cetuximab in platinum-resistant and in cetuximab-resistant human papillomavirus-unrelated head and neck cancer: a multicentre, multigroup, phase 2 trial. Lancet Oncol. 2019 Sep;20(9):1295-1305. doi: 10.1016/S1470-2045(19)30405-X. Epub 2019 Jul 24.
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Completed
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96
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42
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November 10, 2023
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June 8, 2020 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
Exclusion Criteria:
Arms 2 and 3 of Phase II: patients with HIV infection and antiretroviral therapy are not excluded, as there are no pharmacokinetic tests being performed.
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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United States
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NCT02101034
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201404139
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Washington University School of Medicine
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Same as current
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Washington University School of Medicine
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Same as current
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Pfizer
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Principal Investigator: |
Douglas Adkins, M.D. |
Washington University School of Medicine |
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Washington University School of Medicine
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December 2023
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