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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-03171 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EAY131-Z1B | Other Identifier | ECOG-ACRIN Cancer Research Group | |
| EAY131-Z1B | Other Identifier | CTEP | |
| U10CA180820 | U.S. NIH Grant/Contract | View source | |
| U24CA196172 | U.S. NIH Grant/Contract | View source |
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This phase II MATCH treatment trial identifies the effects of palbociclib in patients whose cancer has genetic changes called CCND1, 2, or 3 amplification. Palbociclib blocks proteins called CDK4 and CDK6, which may stop cancer cell growth when CCND1, 2, or 3 amplifications are present. Researchers hope to learn if palbociclib will shrink this type of cancer or stop its growth.
PRIMARY OBJECTIVE:
I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE:
Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (palbociclib) | Experimental | Patients receive palbociclib PO QD days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | Given PO |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR. | Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month Progression-free Survival (PFS) Rate | Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy S Clark | ECOG-ACRIN Cancer Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | Philadelphia | Pennsylvania | 19103 | United States |
To be eligible for this subprotocol, tumors had to contain both an amplification in CCND1, 2, or 3 and Rb expression. CCND amplification was defined as seven or more copies of the gene; Rb expression was defined as 1+ or greater staining by IHC. The mutation status was determined by a CLIA-approved assay performed in a NCI-MATCH approved laboratory for all patients in this arm. Confirmatory central testing was required in order for these patients to be included in the primary analysis.
Subprotocol Z1B was activated on May 31, 2016. Forty patients were enrolled between August 2016 and December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Palbociclib) | Patients receive palbociclib 125 mg PO QD days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Palbociclib: Given PO |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2018 | Feb 25, 2021 |
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| Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined |
| Progression Free Survival (PFS) | PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. | Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration |
| Eligible |
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| Started Protocol Therapy |
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| Eligible and Treated |
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| Mutation Status Confirmed |
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| Eligible, Treated and Mutation Status Confirmed | This is the primary analysis population. |
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| COMPLETED | Treatment continued until disease progression or intolerability. |
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| NOT COMPLETED |
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Patients who were eligible, started protocol therapy, and had mutation status confirmed at the analysis time were the analyzable patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Palbociclib) | Patients receive palbociclib 125 mg PO QD days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Palbociclib: Given PO |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR. | Eligible, treated and mutation status confirmed | Posted | Count of Participants | Participants | Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration |
|
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| ||||||||||||||||||||||||||
| Secondary | 6-month Progression-free Survival (PFS) Rate | Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point. | Eligible, treated and mutation status confirmed | Posted | Number | 90% Confidence Interval | percentage of participants | Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. | Eligible, treated and mutation status confirmed | Posted | Median | 90% Confidence Interval | months | Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration |
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Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
All patients enrolled were included in the all-cause mortality analysis. Thirty-eight patients were included in the toxicity analysis (excluding two who did not receive treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Palbociclib) | Patients receive palbociclib 125 mg PO QD days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Palbociclib: Given PO | 38 | 40 | 20 | 38 | 25 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Death NOS | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Fever | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE 4.0 | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Investigations - Other, specify | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Cancer Research Group | 617-632-3012 | eatrials@jimmy.harvard.edu |
| Prot_001.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C500026 | palbociclib |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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