Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

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Disease Information

Descriptive Information
Brief Title † Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
Official Title † Phase II Study of Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
Brief Summary The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Progression Free Survival (PFS)
Secondary Outcome Measure † Response Rate
Condition † Biliary Carcinoma Gall Bladder Carcinoma Cholangiocarcinoma Gastrointestinal Tumor
Intervention † DrugCisplatin
Study Arms / Comparison Groups Combination Therapy Treatment Plan: Cisplatin (25 mg/m^2 ) + Gemcitabine (1000 mg/m^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 25
Start Date † June 28, 2016
Completion Date December 2018
Primary Completion Date December 2018
Eligibility Criteria † Inclusion Criteria: - Must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease. Patients with ampullary carcinoma are not eligible. - Must not have received any systemic chemotherapy for advanced biliary cancer. - Patients who received adjuvant chemotherapy plus or minus radiation and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are not eligible. If patients received adjuvant treatment and had disease recurrence after 6 months, patients will be eligible. - Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0 or 1. - Must have radiographic measurable disease. - Life expectancy of at least 12 weeks (3 months). - For patients who have received prior radiation, cryotherapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: 28 days have elapsed since that therapy; Lesions that have not been treated with local therapy must be present and measureable. - Adequate bone marrow, liver and liver function. - Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Men and women of childbearing potential must agree to use adequate contraception beginning at the signing of the Informed Consent Form (ICF) until at least 3 months after the last dose of study drug. - Must be able to swallow and retain oral medication. Exclusion Criteria: - Previous or concurrent cancer within 3 years prior to treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]. - Congestive heart failure > New York Heart Association (NYHA) class 2. - Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). - Myocardial infarction less than 6 months before study enrollment - Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg despite optimal medical management). - Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before enrollment. - Non-healing wound, ulcer, or bone fracture. - Active clinically serious infections (> Common Terminology Criteria for Adverse Events (CTCAE) grade 2). - Known history of human immunodeficiency virus (HIV) infection. - Known active Hepatitis B or C. - A seizure disorder requiring medication. - Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks of start of study enrollment. - Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. - Known hypersensitivity to any of the test drugs, test drug classes, or excipients in the formulation. - History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function. - Unresolved toxicity higher than CTCAE grade 1 attributed to any prior therapy/procedure excluding alopecia. - HbA1c >8.5% or fasting plasma glucose > 160 mg/dL at screening. - Concurrent diagnosis of pheochromocytoma. - Women who are pregnant or breast feeding. - Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Richard D. Kim, M.D., 813-745-1277,
Location Countries † United States
Administrative Information
NCT ID † NCT02631590
Organization ID MCC-18435
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † H. Lee Moffitt Cancer Center and Research Institute
Collaborators †† Bayer
Investigators † Principal Investigator: Richard D. Kim, M.D., H. Lee Moffitt Cancer Center and Research Institute
Information Provided By
Verification Date February 2017
First Received Date † December 14, 2015
Last Updated Date February 21, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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