Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or … (NCT02375880) | Clinical Trial Compass
CompletedPhase 1
Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder
United States51 participantsStarted 2015-06
Plain-language summary
DKN-01 is a humanized monoclonal antibody (Mab) with neutralizing activity against Dkk-1 and is being developed as an anti-neoplastic agent. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of DKN-01 in combination with gemcitabine and cisplatin in patients with carcinoma primary to the intra- or exta-hepatic biliary system or gallbladder.
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient has carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder.
✓. Patient must have sufficient tumor tissue available for submission.
✓. For patients who have received prior cryotherapy, radiofrequency ablation, radioembolization, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, at least 28 days must have elapsed since that therapy, and lesions that have not been treated with local therapy must be present and measurable.
✓. Patients may have received prior adjuvant chemotherapy with gemcitabine with or without cisplatin, as long as 6 months have elapsed since last treatment.
✓. Patients must have one or more tumors measurable on radiographic imaging as defined by RECIST.
✓. ECOG PS of 0 or 1. Patients with an ECOG PS of 2 may be entered upon review and approval of the medical monitor.
✓. Estimated life expectancy of at least 3 months.
✓. Disease-free of active second/secondary or prior malignancies for ≥ 2 years with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
Exclusion criteria
✕. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
✕. Have Fridericia-corrected QT interval (QTcF) \> 470 msec (female) or \> 450 (male), or history of congenital long QT syndrome.
What they're measuring
1
Maximum tolerated dose and dose-limiting toxicities as determined in Part A.
Timeframe: End of Cycle 1 (Day 21)
2
Composite Safety parameters as assessed by new or changing physical examinations, vital signs, electrocardiograms (ECGs), clinical laboratories, concomitant medication reviews, and assessment of adverse events.
Timeframe: Parts A and B: at a minimum Days 1, 8, 15 of each treatment cycle.