A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma

NCT04003896 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PSCI-18-052
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Carcinoma

Keywords

Biliary Tract Carcinoma; Abemaciclib

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  overall response rate (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.The scale of ORR ranges from 0% to 100%, where 0% indicates no subjects achieved CR or PR, and 100% indicates all evaluable subjects achieved CR or PR.

  no longer than 7 months

Secondary Outcomes (8)

• Progression-free Survival

  through study completion, an average of 2 years

• Disease Control Rate

  no longer than 7 months

• Overall Survival Rate

  up to 6 months

• Overall Survival Rate

  up to 12 months

• Quality of Life Score

  Prior to treatment with Abemaciclib (baseline)

Study Arms (1)

Abemaciclib

EXPERIMENTAL

Abemaciclib will be given as a single oral agent A sample size of 10 subjects is determined to be minimally sufficient for these pilot study objectives. 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

Interventions

Abemaciclib DRUG

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.

Also known as: Verzenio

Abemaciclib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 18 years at the time of informed consent.
• Capable and willing to sign informed consent form prior to performing any protocol-related procedures.
• 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.
• Evidence of recurrent, locally advanced, unresectable, or metastatic disease.
• Progressed following or intolerant to one or more lines of systemic therapy, or treatment-naïve subjects who either decline or being considered not a good candidate first-line systemic chemotherapy per the opinion of the treating physician
• Per the opinion of the physician investigator, predicted life expectancy \> 3 months.
• Presence of at least 1 lesion that is measurable or evaluable using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
• 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.
• Ability to swallow capsules.
• Adequate organ function as evidenced by the laboratory parameters noted in Section 3.0 Study Eligibility.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• Ongoing or active infection requiring systemic antibiotics.
• 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).
• Diabetes mellitus and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
• 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.
• Primary brain tumor or brain metastases from another primary site.
• Known history of human immunodeficiency virus (HIV).
• Known active viral hepatitis B or viral hepatitis C.
• 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.
• Congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), or acute coronary syndromes within 6 months of enrollment.
• Female subjects who are pregnant or breastfeeding.
• 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.
• Use of an investigational drug within 1 month before the screening visit or currently participating in another investigational study.
• Any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including extensive gastrointestinal surgery that involves removal of the entire stomach or most of the small intestine or large intestine, bariatric surgery, uncontrolled active Crohn's Disease or ulcerative colitis, or preexisting condition resulting in baseline Grade 2 or higher diarrhea). History of Whipple's procedure is permitted.
• 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.
• The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\].

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033-0850, United States

Location

MeSH Terms

Interventions

abemaciclib

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Nelson Yee
• Organization: Penn State Health

nyee@pennstatehealth.psu.edu

7175310003

Study Officials

• Nelson Yee, MD, Ph.D

  Penn State Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a pilot study to confirm tolerability of abemaciclib and provide an estimate of the overall response rate. A sample size of 10 subjects is determined to be minimally sufficient for these pilot study objectives. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death.

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 1, 2019
• Study Start: September 24, 2021
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Locations

US (1)