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Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05554367
Recruitment Status : Not yet recruiting
First Posted : September 26, 2022
Last Update Posted : November 9, 2022
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II clinical trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA.

Condition or disease Intervention/treatment Phase
Malignant Solid Neoplasm Ovarian Low Grade Serous Adenocarcinoma Pancreatic Carcinoma Stage IV Ovarian Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Drug: Binimetinib Procedure: Biopsy Procedure: Biospecimen Collection Procedure: Bone Scan Procedure: Computed Tomography Procedure: Magnetic Resonance Imaging Drug: Palbociclib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A ComboMATCH Treatment Trial: Palbociclib and Binimetinib in RAS-Mutant Cancers
Estimated Study Start Date : December 9, 2022
Estimated Primary Completion Date : August 26, 2026
Estimated Study Completion Date : August 26, 2026


Arm Intervention/treatment
Experimental: Combination Cohorts 1, 2, 3, 4 (palbociclib, binimetinib)
Patients receive palbociclib PO and binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.
Drug: Binimetinib
Given PO
Other Names:
  • ARRY-162
  • ARRY-438162
  • MEK162
  • Mektovi

Procedure: Biopsy
Undergo biopsy
Other Names:
  • BIOPSY_TYPE
  • Bx

Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Procedure: Bone Scan
Undergo bone scan
Other Name: Bone Scintigraphy

Procedure: Computed Tomography
Undergo CT
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Drug: Palbociclib
Given PO
Other Names:
  • 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
  • Ibrance
  • PD 0332991
  • PD 332991
  • PD 991
  • PD-0332991

Experimental: Monotherapy Cohort 1 (binimetinib)
Patients receive binimetinib PO throughout the trial. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.
Drug: Binimetinib
Given PO
Other Names:
  • ARRY-162
  • ARRY-438162
  • MEK162
  • Mektovi

Procedure: Biopsy
Undergo biopsy
Other Names:
  • BIOPSY_TYPE
  • Bx

Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Procedure: Bone Scan
Undergo bone scan
Other Name: Bone Scintigraphy

Procedure: Computed Tomography
Undergo CT
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging




Primary Outcome Measures :
  1. Progression free survival (PFS) (Cohort 1) [ Time Frame: Time from randomization date until the time of disease progression or death due to any cause, assessed at 6, 12, 18, 24, and 30 months ]
    Will compare the PFS distributions between those treated with palbociclib and binimetinib vs. binimetinib alone. PFS will be compared between the two treatment arms using Kaplan-Meier methods. The hazard ratio, median PFS, and estimated PFS rates at 6, 12, 18, 24, and 30 months will be estimated along with corresponding 95% confidence intervals. A log-rank test will be used to compare the PFS distributions between the two treatment arms in this cohort. In an ancillary manner, Cox proportional hazards models will also be used to assess the impact of treatment arm on PFS when stratifying on the stratification factors.

  2. Objective response rate (ORR) (Cohort 2) [ Time Frame: Up to 3 years ]
    The Simon optimal design used to evaluate efficacy in terms of the objective response rate after treatment in this population will use a two-stage design.

  3. ORR (Cohort 3) [ Time Frame: Up to 3 years ]
    The Simon minimax design used to evaluate efficacy in terms of the objective response rate after treatment in this population will use a two-stage design.

  4. ORR (Cohort 4) [ Time Frame: Up to 3 years ]
    The Simon minimax design used to evaluate efficacy in terms of the objective response rate after treatment in this histology/tumor agnostic population will use a two-stage design.


Secondary Outcome Measures :
  1. Objective response (Cohort 1) [ Time Frame: Up to 3 years ]
    Objective response by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria will be estimated using ORR where ORR is defined as the number of evaluable patients achieving a response (partial response [PR] or complete response [CR] per RECIST v1.1) during treatment with study therapy divided by the total number of evaluable patients. Rates of response will be compared between treatment arms using a chi-square test (or Fisher's exact test as needed). Point estimates will be generated for objective response rates within each arm along with 95% confidence intervals using the Clopper-Pearson method.

  2. PFS (Cohorts 2, 3, 4) [ Time Frame: from study entry to the first of either disease progression or death from any cause, assessed up to 3 years ]
    Disease progression will be determined based on RECIST 1.1 criteria. PFS will be estimated using the Kaplan-Meier method. The median PFS and corresponding 95% confidence interval will be reported. Patients will be censored at the last disease assessment date if they were alive and progression-free at the time of their last assessment.

  3. Overall survival (OS) (All Cohorts) [ Time Frame: From registration until death due to any cause, assessed up to 3 years ]
    Patients who are alive at last follow-up will be censored at that time point. The distribution of OS will be estimated using method of Kaplan-Meier. The median OS and 95% confidence interval will be reported.

  4. Duration of response (DoR) (All Cohorts) [ Time Frame: From patient's earliest best objective status to earliest date of progression, assessed up to 3 years ]
    DoR is defined for all evaluable patients who have achieved an objective response as time from the patient's earliest best objective status is first noted as either a CR or PR to the earliest date progression is documented, or death if no prior evidence of disease progression. The distribution of DoR will be estimated using the method of Kaplan-Meier.

  5. Disease control (All Cohorts) [ Time Frame: Up to 3 years ]
    Disease control will be estimated using disease control rate (DCR), which is defined as the patients who experience CR or PR per RECIST 1.1 or maintain stable disease for at least 6 months after randomization divided by the total number of evaluable patients. DCR will be evaluated within cohorts, and for cohort 1 this will also be compared between treatment arms using a chi square test. Point estimates will be generated for disease control rates within each arm along with 95% confidence intervals using the Clopper-Pearson method.

  6. Incidence of adverse events (AE) (All Cohorts) [ Time Frame: Up to 3 years ]
    All eligible patients that have initiated treatment will be considered evaluable for assessing AE rate(s). Patients will be evaluated for adverse events using the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 5.0. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the AE(s) to the study treatment will be taken into consideration.


Other Outcome Measures:
  1. TK1 activity (Cohorts 1 and 2) [ Time Frame: Up to 3 years ]
    Will explore TK1 activity before vs. after treatment and how this corresponds and correlates to clinical outcomes after treatment with palbociclib.

  2. KRAS mutations (Cohorts 1 and 2) [ Time Frame: Up to 3 years ]
    Will characterize patients based on presence of KRAS mutations and how these correspond to efficacy outcomes such as PFS and response to treatment. Further, for cohort 1, will also evaluate how presence of this mutation influences outcomes in patients treated with monotherapy vs. the combination therapy. If numbers are sufficient, will also explore if KRAS mutation has any role as an effect modifier in this setting.

  3. Determinants of response and resistance (Cohorts 1 and 2) [ Time Frame: Up to 3 years ]
    Will conduct whole-exome sequencing and ribonucleic acid (RNA)-sequencing at baseline, and on optional biopsy upon progression to assess determinants of response and resistance. For cohort 1, concordance of diagnostic tumor mutation profile generated by the designated laboratory, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutation profile will be assessed.

  4. Changes in plasma RAS allelic burden in KRAS-mutated tumors (Cohorts 1 and 2) [ Time Frame: Up to 3 years ]
    Will explore changes in plasma RAS allelic burden in KRAS-mutated tumors using ctDNA and correlate changes with clinical activity.

  5. TK1 activity (Cohorts 3 and 4) [ Time Frame: Up to 3 years ]
    Will explore TK1 activity before vs. after treatment and how this corresponds and correlates to clinical outcomes after treatment with palbociclib.

  6. Determinants of response (Cohorts 3 and4) [ Time Frame: Up to 3 years ]
    Will evaluate change in deoxyribonucleic acid (DNA), RNA, and ctDNA. Concordance of diagnostic tumor mutation profile generated by the designated laboratory, the pre-treatment biopsy mutation profile, and the pre-treatment ctDNA mutation profile will be assessed.

  7. Signatures of intrinsic resistance or response (Cohorts 3 and 4) [ Time Frame: Up to 3 years ]
    Will evaluate change in DNA, RNA, and ctDNA. Concordance of diagnostic tumor mutation profile generated by the designated laboratory, the pre-treatment biopsy mutation profile, and the pre-treatment ctDNA mutation profile will be assessed.

  8. Plasma RAS allelic burden in in relation to response (Cohorts 3 and 4) [ Time Frame: Up to 3 years ]
    Will evaluate change in DNA, RNA, and ctDNA. Concordance of diagnostic tumor mutation profile generated by the designated laboratory, the pre-treatment biopsy mutation profile, and the pre-treatment ctDNA mutation profile will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GENERAL ComboMATCH EAY191 REGISTRATION INCLUSION CRITERIA:
  • Patients must fulfill all eligibility criteria outlined the ComboMATCH Registration Protocol (EAY191) at the time of registration to study. This includes submission of next-generation sequencing (NGS) data from one of the MATCH Designated Laboratories for all potential patients prior to treatment trial assignment. Copy number and allele frequency cutoffs as per the Registration Protocol
  • Patients must be enrolled on the ComboMATCH Master Registration Trial EAY191
  • Patients must have KRAS/NRAS/HRAS or BRAF alterations as determined by the ComboMATCH screening assessment
  • Patients with low grade serous ovarian cancer who have progressed on a prior MEK inhibitor are not required to have a KRAS/NRAS/HRAS or BRAF alteration
  • Patients with a tumor harboring KRAS G12C mutation will be eligible either after they have received a G12C inhibitor or can be enrolled if they do not meet eligibility for a G12C inhibitor
  • Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to registration
  • Please note the current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website: www.ctsu.org (final URL pending)
  • EAY191-A3 INCLUSION CRITERIA:
  • Histologically confirmed cancer for each cohort for which curable treatment modalities are not an option
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. There is a mandatory baseline biopsy for all ComboMATCH studies. Hence, patient must have a biopsiable lesion at baseline. Of note, in the case when a baseline biopsy is done after scans are obtained, a lesion separate from one that is biopsied needs to be measurable per RECIST 1.1. All radiologic studies must be performed within 28 days prior to randomization
  • COHORT 1: Low grade serous ovarian cancer with KRAS, NRAS or BRAF activating mutation
  • COHORT 1: No prior MEK inhibitor or CDK4/6 inhibitor therapy
  • COHORT 1: Any number of prior therapies permitted
  • COHORT 1: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
  • COHORT 1: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
  • COHORT 2: Low grade serous ovarian cancer
  • COHORT 2: Prior progression of disease on a MEK inhibitor (prior binimetinib permitted)
  • COHORT 2: If patient has previously received binimetinib, they cannot have required dose reduction or discontinuation of binimetinib due to adverse events
  • COHORT 2: No prior receipt of a CDK4/6 inhibitor
  • COHORT 2: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
  • COHORT 2: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
  • COHORT 3: Pancreatic cancer with KRAS/NRAS/HRAS/non-V600E BRAF alterations are permitted
  • COHORT 3: No prior MEK inhibitor (MEKi) and CDK4/6i therapy
  • COHORT 3: Progression after at least one line of prior therapy as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit
  • COHORT 3: Any number of prior therapies are permitted
  • COHORT 3: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
  • COHORT 3: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
  • COHORT 4: KRAS/NRAS/HRAS activating mutations
  • COHORT 4: No prior MEKi and CDK4/6i therapy and progression after at least one line of prior therapy, as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit
  • COHORT 4: Any number of prior therapies are permitted
  • COHORT 4: No more than 6 patients with a given tumor type allowed in this cohort
  • COHORT 4: Any tumor type, except: LGSOC/NSCLC/CRC/pancreatic/melanoma
  • COHORT 4: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
  • COHORT 4: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
  • Note: Within ComboMATCH, patients with tumors harboring KRAS G12C mutation will be prioritized for a G12C inhibitor-based substudy if eligible
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin > 9 g/dL
  • Creatinine =< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance >= 30 mL/min as calculated by the Cockcroft-Gault formula
  • Total bilirubin =< 1.5 x upper limit of normal (ULN). Patients with Gilbert syndrome may enroll if total bilirubin (bili) < 3 mg/dL (51 micromole/L)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
  • Creatine phosphokinase (CPK) =< 2.5 x ULN
  • Patients must be able to swallow oral formulations of the agents
  • No history of interstitial lung disease. No history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • No active skin disorder that has required systemic therapy within the past 1 year
  • No history of rhabdomyolysis
  • No concurrent ocular disorders including:

    • Subjects with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes
    • Subject with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure > 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO
    • Subjects with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions
  • No prior allogeneic stem cell or solid organ transplantation
  • Central nervous system (CNS) metastases must have been treated with local therapy (surgery, radiation, ablation) and patient off of systemic steroids, and brain metastases stable for at least 1 month
  • No residual Common Terminology Criteria for Adverse Events (CTCAE) >= grade 2 toxicity from any prior anticancer therapy, with the exception of grade 2 alopecia or grade 2 neuropathy
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • No exposure to P-glycoprotein (P-gp) inhibitors or inducers within 14 days prior to the first dose and during the course of therapy
  • Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study and for 3 months after the last dose of study agent due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom). A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

  • GENERAL ComboMATCH EAY191 REGISTRATION EXCLUSION CRITERIA:
  • Patients must not have BRAF V600E as determined by the ComboMATCH screening assessment
  • EAY191-A3 EXCLUSION CRITERIA:
  • Patients should not have history of bowel perforation or intestinal fistulas in the last 6 months
  • No patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease
  • No patients with a history of hypersensitivity to any of the study drug(s)
  • Patients whose left ventricular ejection fraction (LVEF) has been evaluated by echocardiography (ECHO)/multigated acquisition scan (MUGA) are excluded if the most recent exam shows an LVEF < 50%
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
  • Physicians should consider whether any of the following may render the patient inappropriate for this protocol:

    • Medical condition (e.g. cardiac, gastrointestinal, pulmonary, psychiatric, neurological, genetic, etc.) that in the opinion of the investigator would places the subject at unacceptably high risk for toxicity
    • Patients with a "currently active" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 3 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05554367


Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Geoffrey I Shapiro Alliance for Clinical Trials in Oncology
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT05554367    
Other Study ID Numbers: NCI-2022-07266
NCI-2022-07266 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAY191-A3 ( Other Identifier: Alliance for Clinical Trials in Oncology )
EAY191-A3 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2022    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
URL: https://grants.nih.gov/policy/sharing.htm

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Cystadenocarcinoma, Serous
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action