Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
Phase II Study of Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedStudy Start
First participant enrolled
July 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2019
CompletedResults Posted
Study results publicly available
November 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2021
CompletedAugust 4, 2021
August 1, 2021
3.3 years
December 14, 2015
October 8, 2020
August 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS at six months. Response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). PFS will be calculated from study entry to documented disease progression, death from any cause, or date of last follow-up, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
6 months
Secondary Outcomes (2)
Response Rate
Up to 24 months
Overall Survival (OS)
Up to 24 months
Study Arms (1)
Combination Therapy
EXPERIMENTALTreatment 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.
Interventions
Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.
Eligibility Criteria
You may qualify if:
- 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.
- Availability of archival tumor tissue for biomarkers analysis (minimum of 10 unstained slides are optional). Specimen from primary site will be allowed.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lee Moffitt Cancer Center and Research Institutelead
- Bayercollaborator
Study Sites (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Related Publications (1)
Tan ES, Cao B, Kim J, Al-Toubah TE, Mehta R, Centeno BA, Kim RD. Phase 2 study of copanlisib in combination with gemcitabine and cisplatin in advanced biliary tract cancers. Cancer. 2021 Apr 15;127(8):1293-1300. doi: 10.1002/cncr.33364. Epub 2020 Dec 8.
PMID: 33289918DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Kim, MD, Principal Investigator
- Organization
- Moffitt Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Richard D. Kim, M.D.
H. Lee Moffitt Cancer Center and Research Institute
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
- SPONSOR
Study Record Dates
First Submitted
December 14, 2015
First Posted
December 16, 2015
Study Start
July 5, 2016
Primary Completion
October 25, 2019
Study Completion
March 5, 2021
Last Updated
August 4, 2021
Results First Posted
November 2, 2020
Record last verified: 2021-08