check_circleStudy Completed

Neoplasms

Phase 1 study of PI3 (phosphatidylinositol-3)-kinase inhibitor Copanlisib with gemcitabine or cisplatin plus gemcitabine in patients with advanced cancer

Trial purpose

This open label Phase I study involves treating subjects with advanced cancer with Copanlisib in combination with either gemcitabine or cisplatin plus gemcitabine. It will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Copanlisib in combination with gemcitabine and Copanlisib in combination with cisplatin and gemcitabine. The trial will involve multiple participating sites from the US. Up to a maximum of 70 subjects will be enrolled in the study.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
50
Trial Dates
November 2011 - December 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Tampa, 33612, United States
Completed
Chapel Hill, 27599-7305, United States
Completed
Rochester, 55905, United States

Primary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum tolerated dose, measured by adverse event profile
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Maximum drug concentration in plasma (Cmax) of Copanlisib with gemcitabine or cisplatin plus gemcitabine
    date_rangeTime Frame:
    Approximately 18 months
    enhanced_encryption
    Safety Issue:
    No
  • The time of the maximum concentration (Tmax) of Copanlisib with gemcitabine or cisplatin plus gemcitabine
    date_rangeTime Frame:
    Approximately 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Area under the curve (AUC) of Copanlisib with gemcitabine or cisplatin plus gemcitabine
    date_rangeTime Frame:
    Approximately 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Area under the concentration time curve (AUC (0-tn)) of Copanlisib with gemcitabine or cisplatin plus gemcitabine
    date_rangeTime Frame:
    Approximately 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Half life (t1/2) of Copanlisib with gemcitabine or cisplatin plus gemcitabine
    date_rangeTime Frame:
    Approximately 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Biomarker evaluation including analysis of pathway activation in tumor tissue and blood/plasma
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
    enhanced_encryption
    Safety Issue:
    No
  • Tumor Response as measured by RECIST 1.1 criteria
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase 1 study of Copanlisib(phosphatidylinositol-3 kinase inhibitor) in combination with gemcitabine (Treatment A) or cisplatin plus gemcitabine (Treatment B) in subjects with advanced solid malignancy
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
2