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Trial record 95 of 1312 for:    survival | Neuroendocrine Tumors

Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT03891784
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This phase II trial studies how well abemaciclib works in treating patients with digestive system neuroendocrine tumors that have spread to other places in the body, do not respond to treatment, and cannot be removed by surgery. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition or disease Intervention/treatment Phase
Advanced Digestive System Neuroendocrine Neoplasm Digestive System Neuroendocrine Tumor Foregut Carcinoid Tumor Hindgut Carcinoid Tumor Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm Metastatic Digestive System Neuroendocrine Neoplasm Midgut Carcinoid Tumor Pancreatic Neuroendocrine Tumor Refractory Digestive System Neuroendocrine Neoplasm Drug: Abemaciclib Phase 2

Detailed Description:

Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 4 months for up to 1 year.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of the CDK4/6 Inhibitor Abemaciclib in Patients With Advanced and Refractory Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs)
Estimated Study Start Date : September 23, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2024


Arm Intervention/treatment
Experimental: Treatment (abemaciclib)
Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Abemaciclib
Given PO
Other Names:
  • Verzenio
  • 1231929-97-7
  • 2-Pyrimidinamine




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 1 year ]
    ORR defined as complete or partial response as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, will be represented by a waterfall plot.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: From study registration to radiographic progression per RECIST v1.1 (investigator assessment), clinical progression, or death of any cause, assessed up to 1 year ]
    The distribution for survival times will be estimated using the method of Kaplan-Meier; associated landmark time percentages and the median value will be based on this. Confidence intervals for median values will use the Brookmeyer-Crowley method. Survival outcomes between carcinoid tumors and pancreatic neuroendocrine tumor (PNET)s will be compared using a log-rank test.

  2. Overall survival [ Time Frame: Time from study registration to death of any cause, assessed up to 1 year ]
    The distribution for survival times will be estimated using the method of Kaplan-Meier; associated landmark time percentages and the median value will be based on this. Confidence intervals for median values will use the Brookmeyer-Crowley method. Survival outcomes between carcinoid tumors and PNETs will be compared using a log-rank test.

  3. Incidence of adverse events [ Time Frame: Up to 30 days ]
    Safety will be evaluated by assessing the adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.



Information from the National Library of Medicine

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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:

  • Histologically confirmed GEP NET, radiographically progressed on at least one line of standard therapy within the past 12 months

    • Primary tumors may be in: pancreas, foregut (esophagus, stomach, duodenum), midgut (small intestine, appendix), hindgut (large intestine, rectum), or unknown origin
    • Tumors may be functional (associated with clinical symptoms of hormone secretion) or non-functional
  • Well-differentiated low grade (Ki67 index < 3% or mitotic index < 2 mitoses/10 high power fields [HPF]), or intermediate grade (Ki67 index 3-20% or mitotic index 2-20 mitoses/10 HPF) NETs
  • Metastatic or locally advanced unresectable disease
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
  • Prior or concurrent therapy with somatostatin analogs (SSAs) is allowed. If concurrent therapy, dose must be stable for at least 2 months
  • Patients with carcinoid syndrome must have symptoms controlled with stable doses of SSAs for at least 2 months

    * Telotristat is not allowed

  • Available archival tumor tissue (formalin-fixed paraffin-embedded [FFPE]) or willing to provide a fresh tumor biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Able to swallow oral medications
  • Absolute neutrophil count >= 1500/uL
  • Platelet count >= 100,000/uL (without platelet transfusion for at least two weeks)
  • Hemoglobin >= 8 g/dL (without blood transfusion for at least two weeks)
  • Total bilirubin =< 1.5 times upper limit of normal (ULN)
  • Transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) (=< 5 x ULN if liver metastases)
  • Patients with Gilbert's syndrome with a total bilirubin =< 2.0 times ULN and direct bilirubin within normal limits are permitted
  • International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN
  • Serum creatinine =< 1.5 x ULN
  • Ability to understand and sign the consent form
  • Women of child-bearing potential must:

    • Have a negative serum pregnancy test within 7 days prior to initiation of treatment, and
    • Agree to use a highly effective method of contraception during the study and for at least 3 months following the last dose of study drug
  • Men must be sterile or agree to use a highly effective method of contraception during the study and for at least 3 months following the last dose of study drug

Exclusion Criteria:

  • Poorly differentiated or high-grade GEP NETs (Ki67 index > 20% or mitotic index > 20 mitoses/10 HPF)
  • Prior treatment with abemaciclib or other CDK4/6 inhibitors
  • Known hypersensitivity to abemaciclib or its components
  • Receipt of any therapy or investigational agent within 4 weeks prior to study registration, except SSAs
  • Any surgery, radiation, or embolization within 4 weeks
  • Peptide receptor radionuclide therapy within 6 weeks
  • Patients receiving other investigational agents
  • Patients who have not recovered from adverse events (AEs) of prior therapy to =< grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5), except for alopecia
  • Patients with untreated or symptomatic brain metastases (must be off corticosteroids for >= 4 weeks)
  • Uncontrolled or untreated intercurrent illness including, but not limited to, active infection, congestive heart failure, severe/unstable angina, interstitial lung disease, severe dyspnea at rest or requiring oxygen supplementation, arterial or venous thrombotic event, or psychiatric illness/social situations that would limit compliance with study requirements
  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures involving stomach or small bowel in the last 28 days, active peptic ulcer disease, Crohn's disease or ulcerative colitis
  • Other malignancy diagnosed or recurrent in the past 3 years (except non-melanoma skin cancer and in-situ cervical cancer)
  • Pregnancy or breast-feeding

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): NCT03891784


Contacts
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Contact: Kaylyn Kit Man Wong 206-606-2038 kkmwong@seattlecca.org

Locations
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United States, Colorado
University of Colorado Not yet recruiting
Denver, Colorado, United States, 80217
Contact: Stephen Leong    303-724-3837      
Principal Investigator: Stephen Leong         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Kaylyn Kit Man Wong    206-606-2038    kkmwong@seattlecca.org   
Principal Investigator: Kaylyn Kit Man Wong         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kaylyn Kit Man Wong Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03891784     History of Changes
Other Study ID Numbers: RG1004456
NCI-2019-01490 ( Registry Identifier: NCI / CTRP )
9959 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoid Tumor
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Gastrointestinal Neoplasms
Adenoma, Islet Cell
Adenocarcinoma
Carcinoma
Adenoma
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Stomach Diseases