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BOLSTER: Cholangiocarcinoma (Bile Duct Cancer) Clinical Trial

BOLSTER trial design

Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating certepetide when added to standard-of-care versus standard-of-care alone in patients with first-line cholangiocarcinoma. Certepetide is not FDA approved.

BOLSTER trial objective

Evaluate the preliminary efficacy, safety, and tolerability of certepetide in combination with standard-of-care (gemcitabine/cisplatin/durvalumab) in patients with first-line cholangiocarcinoma.

Locations Actively Recruiting Clinical Trial Patients

The principal investigator is the physician responsible for the scientific and technical direction of the clinical trial at each respective location.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided below. Please refer to this study as LSTA1-P02.

UNITED STATES 

Arizona, USA

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

Contact: Madappa Kundranda, MD, PhD | tel: 480-256-6444 | email: Madappa.kundranda@bannerhealth.com

Principal Investigator: Madappa Kundranda, MD, PhD

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

Contact: Clinical Trials Referral Office | tel: 855-776-0015

Principal Investigator: Bassam Sonbol, MD

University of Arizona Cancer Center

Tucson, Arizona, United States, 85719

Contact: Prisca Zimmerman | email: priscaz@arizona.edu

Principal Investigator: Rachna Shroff, MD


California, USA

Providence Medical Foundation

Fullerton, California, United States, 92835

Contact: Linda Gozar | tel: 714-992-3000 Ext. 4332 |email: Linda.Gozar@stjoe.org

Principal Investigator: David Park, MD


Florida, USA

Moffitt Cancer Center

Tampa Florida, United States, 33612

Contact: Taylor Atkinson | tel: 813-745-6851 | email: taylor.atkinson@moffitt.org

Principal Investigator: Richard Km, MD


Kansas, USA

University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

Contact: Shannon Bradbury | email: sbradbury@kumc.edu

Principal Investigator: Anup Kasi, MD, MPH


Kentucky, USA

Norton Cancer Institute, Audubon

Louisville, Kentucky, United States, 40217

Contact: MISC-NCIResearch@nortonhealthcare.org

Principal Investigator: Michael Driscoll, MD

Norton Cancer Institute, Downtown

Louisville, Kentucky, United States, 40202

Contact: MISC-NCIResearch@nortonhealthcare.org

Principal Investigator: Michael Driscoll, MD

University of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

Contact: Sarah Howard | tel: 859-323-8749

Principal Investigator: Susanne Arnold, MD


Minnesota, USA

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Contact: Clinical Trials Referral Office | tel: 855-776-0015

Principal Investigator: Nguyen Tran, MD


New York, USA

Northwell Health – Zuckerberg Cancer Center

Lake Success, New York, United States, 11042

Contact: Jenna Battaglia | tel: 516-734-8812 | email: jbattaglia2@northwell.edu

Principal Investigator: Anna Levy, DO

Stony Brook Cancer Center

Stony Brook, New York, United States, 11794

Contact: Sumbul Yousafi | tel: 631-638-0829 | email: Sumbul.Yousafi@stonybrookmedicine.edu

Principal Investigator: Roger Keresztes, MD


North Carolina, USA

FirstHealth of the Carolinas, Inc.

Pinehurst, North Carolina, United States, 28374

Contact: Lindsey Ferry | tel: 910-715-2200 | email: lferry@firsthealth.org

Principal Investigator: Charles Kuzma, MD

Novant Health Cancer Institute

Charlotte, North Carolina, United States, 28204

Contact: Demetria Jacks, MD | email: dijacks@novanthealth.org

Principal Investigator: Demetria Jacks, MD

Novant Health Cancer Institute

Winston-Salem, North Carolina, United States, 27103

Contact: Demetria Jacks, MD | email: dijacks@novanthealth.org

Principal Investigator: Demetria Jacks, MD


Ohio, USA

Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center

Cincinnati, Ohio, United States, 45219

Contact: Abby Reed, RN | tel: 513-585-0844

Principal Investigator: Alexander Starodub, MD, PhD


Tennessee, USA

Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee, United States, 37232

Contact: VUMC Patient Recruitment Office | tel: 800-811-8480 | email: CTIP@VUMC.ORG

Principal Investigator: Thatcher Heumann, MD


Texas, USA

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Contact: Ian Hu, MD, PhD | email: GIClinicalTrials@mdanderson.org

Principal Investigator: Ian Hu, MD, PhD


Virgina, USA

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Contact: Stephanie Van Bebber | tel: 571-472-4724 | email: Stephanie.VanBebber@inova.org

Principal Investigator: Raymond Wadlow, MD

cholangiocarcinoma clinical trial

Who may participate in this cholangiocarcinoma clinical trial

Joining a clinical trial is an important and personal decision. Only a qualified healthcare professional can determine whether you are eligible to participate in a clinical trial. However, this information may be beneficial in initiating a conversation with your physician. If you believe this clinical trial might be a good fit and are interested in participating, please take the next step and contact a research site to see if you are eligible.

The BOLSTER trial may be an option if you meet the following eligibility criteria:

  • Male or female and a minimum of 18 years of age
  • If you are a female who can get pregnant, you must use appropriate contraception. If you are male with a female partner who can get pregnant, you must use appropriate contraception.
  • Patients that:
    • Have been diagnosed with metastatic bile duct cancer or bile duct cancer that cannot be surgically removed and have not received any prior anti-cancer treatment

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study. The study doctor will tell you about all the other criteria that you have to meet in order to participate in this Study.

What to expect

  1. Approximately 40 subjects will be enrolled in this clinical research study. If you are interested in participating, the clinical trial team will schedule a screening visit to determine if you are eligible to participate in the BOLSTER trial.

  2. Participants who provide informed consent will be screened for eligibility for up to 28 days. Once eligibility is confirmed, you will be randomly assigned (like flipping a coin) to receive either study drug or placebo (an inactive substance that looks the same as the study drug) in addition to standard chemotherapy.

  3. The first dose of either certepetide or placebo will be given to patients alone without any other medication. Three days later, the first cycle of treatment will start. Tumor scans will be performed every 8 weeks (56 days ± 7 days) while on treatment.

Frequently asked questions