Study of CTX-009 in Combo w/ Paclitaxel in Pts w/ Unresectable Advanced, Metastatic, Recurrent BTC
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StatusAccepting Candidates
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Age18 Years - N/A
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SexesAll
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Healthy VolunteersNo
Objective
This is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel in patients with previously treated, unresectable advanced or metastatic biliary tract cancers.
Details
Full study title | A Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen |
Protocol number | OCR44198 |
ClinicalTrials.gov ID | NCT05506943 |
Phase | Phase 2/Phase 3 |
Eligibility
INCLUSION CRITERIA
18 years of age or older
Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma)
Patients must have radiologically documented progression after a prior gemcitabine and platinum containing chemotherapy regimen as first line therapy for locally advanced unresectable or metastatic disease.
Patients who received perioperative treatment (adjuvant and neoadjuvant) may be eligible, as determined by the Sponsor Medical Monitor.
Patients whose first line regimen was modified due to toxicity before disease progression, may be eligible, as determined by the Sponsor Medical Monitor.
At least one lesion measurable as defined by RECIST v1. 1
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Predicted life expectancy of at least 12 weeks
No evidence of ongoing infection and adequate biliary excretion or patients whose
Adequate biliary excretion can be confirmed with the following procedures:
Patients who underwent endoscopic retrograde biliary drainage (ERBD) at least 1 week before the investigational drug treatment
Patients with endobiliary stents are eligible, provided there is no evidence of obstruction
Patients free of any signs of active or suspected uncontrolled infection after a drainage procedure
Patients free of any risk of hemorrhage and with incision completely healed
Adequate bone marrow, hepatic, and renal function within 14 days of randomization as described below. (Patient must be free of G-CSF treatment and blood transfusion within 14 days prior to the lab test):
Absolute neutrophil count (ANC) ≥ 1,500/mm3
Hemoglobin ≥ 9. 0 g/dL
Platelet count ≥ 100,000/mm3
Total bilirubin ≤ 1. 5 X ULN
AST/ALT ≤ 3. 0 X ULN (≤5 X ULN in case of hepatic metastasis)
Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault
Urine protein ≤ 1+ by Dipstick (Only when urinalysis shows a protein dipstick result of > 1 positive (+), the total protein volume ( 450msec at the time of screening
Lead researcher
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Ilyas Sahin, MDGastroenterologist
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Allison Springer -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.