Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma Who Failed Prior First Line Therapy

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: NCT04003896
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Nelson Yee, MD, PhD, Milton S. Hershey Medical Center

Brief Summary:
The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in patients with late-stage or progressed BTC that has failed one line of chemotherapy.

Condition or disease Intervention/treatment Phase
Biliary Tract Carcinoma Drug: Abemaciclib Phase 2

Detailed Description:

Biliary Tract Carcinoma (BTC) is a leading cause of cancer-related mortality. The newly developed small molecule inhibitor of cyclin-dependent kinases (CDK4 and CDK6), abemaciclib, provides a new opportunity of treating patients with BTC. The goal of this clinical study is to determine the efficacy and safety of abemaciclib in patients with advanced or metastatic BTC that has progressed or intolerant following one line of chemotherapy.

The investigator's objectives for this study are as follows:

Primary Objectives:

• To determine the objective response rate (ORR)

Secondary Objectives:

  • To determine progression free survival (PFS)
  • To determine the disease control rate (DCR)
  • To determine the overall survival (OS) rate at 6 and 12 months
  • To determine quality of life (QoL) using EORTC-QLQ-C30

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a Phase 2 open label study to determine the efficacy and safety/tolerability of abemaciclib in participants with locally advanced, unresectable, or metastatic biliary tract cancer who have failed (tumor progression or patient intolerance) one or more lines of systemic therapy. A Simon's two-stage design will be used. If there are no responses in the first 13 patients with a determined outcome, the study will be stopped. Otherwise, 11 additional patients will be accrued for a total of 24. Abemaciclib will be given as a single oral agent Approximately up to 27 subjects may be enrolled to attain at least 24 evaluable participants. The starting dose will be 200 mg twice daily. Dosing will continue daily for 28 days, this being one cycle. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients With Advanced Biliary Tract Carcinoma Who Have Failed Prior Chemotherapy
Estimated Study Start Date : October 31, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Abemaciclib

Arm Intervention/treatment
Experimental: Abemaciclib
Abemaciclib will be given as a single oral agent Approximately up to 27 subjects may be enrolled to attain at least 24 evaluable participants. The starting dose will be 200 mg twice daily. Dosing will continue daily for 28 days, this being one cycle. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death.
Drug: Abemaciclib

Participant will take 200 mg capsules or tablets orally twice daily. The participant will be instructed to swallow abemaciclib as a whole tablet and not to chew, crush or split capsules or tablets before swallowing. Participants should not ingest abemaciclib tablets if broken, cracked, or otherwise not intact. Doses should be taken at a approximately the same time every day, twice daily. Capsules or tablets can be taken orally with or without food. If the participant vomits or misses a dose of abemaciclib, the participant will be instructed to take the next dose at its scheduled time.

Participants will also be provided with a diary and instructed to keep a twice daily record of the times they have taken their medications and any other events such as vomiting, diarrhea, etc.

Other Name: Verzenio




Primary Outcome Measures :
  1. overall response rate [ Time Frame: approximately 7 months ]
    ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 at the beginning of cycle 3, 5, 7 (each cycle is 28 days).


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]
    the time interval from date of first dose of study drug to first documented disease progression or death from any cause, whichever occurs first.

  2. disease control rate [ Time Frame: approximately 7 months ]
    tThe number of subjects achieving a response (complete response, partial response, stable disease) at the beginning of cycle 3, 5, 7 (each cycle is 28 days).

  3. overall survival rate [ Time Frame: up to 12 months ]
    the proportion of subjects who are alive at 6 months and 12 months from the date of first dose of study drug, respectively.

  4. quality of life questionaire [ Time Frame: approximately 8 months ]
    from the date of baseline and then every 4 weeks using the EORTC-QLQ-C30 at the end of cycle 1,2,3,4,5,6,7,8 (each cycle is 28 days).



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.


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

Inclusion Criteria:

  1. Male or female, age ≥ 18 years at the time of informed consent.
  2. Capable and willing to sign informed consent form prior to performing any protocol-related procedures.
  3. Histologic or cytologic evidence of advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intra-hepatic or extra-hepatic bile ducts), ampullary carcinoma, or gallbladder carcinoma.
  4. Evidence of recurrent, locally advanced, unresectable, or metastatic disease.
  5. Progressed following or intolerant to one or more lines of systemic therapy
  6. Per the opinion of the physician investigator, predicted life expectancy > 3 months.
  7. Presence of at least 1 lesion that is measurable or evaluable using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  8. Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
  9. Per the opinion of the physician investigator, acute toxicities relating to any prior anticancer treatment have improved to Grade 1 or baseline. Exceptions include residual alopecia or Grade 2 peripheral neuropathy.
  10. Ability to swallow capsules or tablets.
  11. Adequate organ function as evidenced by the laboratory parameters noted in Section 3.0 Study Eligibility.
  12. Women of childbearing potential (WOCP) defined as not surgically sterile (hysterectomy, tubal ligation, or oophorectomy), or at least 1 year postmenopausal, must have a negative serum pregnancy test before study drug administration on cycle 1 day 1.
  13. WOCP must use a medically acceptable method of contraception and must agree to continue used of this method for the duration of the study and for 3 weeks after last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method.
  14. Male, capable of producing offspring, must use a medical acceptable method of contraception and agree to continued use of this method for the duration of the study and for 3 weeks after last dose of study drug because of the possible effects on spermatogenesis. Acceptable methods of contraception include abstinence, WOCP partner's use of barrier method with spermicide, WOCP partner's use of an IUD known to have a failure rate of less than 1% per year, WOCP partner's use of steroidal contraceptive (oral, transdermal, implanted or injected) or WOCP partner is surgically sterile or at least 1 year post-menopausal. In addition, male subjects may not donate sperm for the duration of the study and for 30 days after last dose of study drug.
  15. Must be willing and able to comply with the protocol, including adhering to study restrictions, remaining at the clinic as required during the study period, and willing to return to the clinic for the follow-up evaluation.

Exclusion Criteria:

  1. Prior therapy as described below:

    1. Completed last radiotherapy treatment within 14 days prior to first dose of study drug.
    2. Completed last dose of myelosuppressive chemotherapy within 21 days prior to first dose of study drug.
    3. Completed last dose of non-myelosuppressive biological or monoclonal antibody therapy within 14 days prior to first dose of study drug.
  2. Ongoing or active infection requiring systemic antibiotics.
  3. Uncontrolled hypertension despite adequate therapy (systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
  4. Diabetes mellitus and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
  5. Active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers treated with curative intent, and no known active disease in the 3 years prior to enrollment.
  6. Primary brain tumor or brain metastases from another primary site.
  7. Known history of human immunodeficiency virus (HIV).
  8. Known active viral hepatitis B or viral hepatitis C.
  9. History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Subjects with controlled atrial fibrillation for more than 30 days are permitted.
  10. Congestive heart failure (New York Heart Association [NYHA] Class III or IV), or acute coronary syndromes within 6 months of enrollment.
  11. Female subjects who are pregnant or breastfeeding.
  12. Any other medical, psychiatric, or social condition, which in the opinion of the physician investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results. For example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy.
  13. Use of an investigational drug within 1 month before the screening visit or currently participating in another investigational study.
  14. Any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal or bariatric surgery, preexisting Crohn's Disease or ulcerative colitis, or preexisting condition resulting in baseline Grade 2 or higher diarrhea).
  15. Known hypersensitivity to any of the components in abemaciclib including micro-crystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients-polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.

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): NCT04003896


Contacts
Layout table for location contacts
Contact: Clinical Research Coordinator RN Penn State Cancer Institute 717 531 5471 PSCI-CTO@pennstatehealth.psu.edu
Contact: Nelson Yee, MD, Ph.D 7175310003 ext 280677 nyee@pennstatehealth.psu.edu

Locations
Layout table for location information
United States, Pennsylvania
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033-0850
Contact: Nelson Yee, MD, Ph.D    717-531-0003 ext 280677    nyee@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Eli Lilly and Company
Investigators
Layout table for investigator information
Principal Investigator: Nelson Yee, MD, Ph.D Penn State Cancer Institute
Layout table for additonal information
Responsible Party: Nelson Yee, MD, PhD, Associate Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04003896    
Other Study ID Numbers: PSCI-18-052
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nelson Yee, MD, PhD, Milton S. Hershey Medical Center:
Biliary Tract Carcinoma
Abemaciclib
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms