NCT01460537 - Phase 1 Study of PI3 (Phosphatidylinositol-3)-Kinase Inhibitor Copanlisib With Gemcitabine or Cisplatin Plus Gemcitabine in Patients With Advanced Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 18, 2011

Primary Completion Date

July 20, 2015

Study Completion Date

December 18, 2015

Conditions

Neoplasms

Interventions

DRUG

Gemcitabine

Gemcitabine 1000mg/m2 as 30-minutes IV infusion

DRUG

BAY80-6946

Escalated dose starting from 0.6 mg/kg in 100 mL of 0.9% NaCl as 60-minutes IV infusion

DRUG

Cisplatin

1 liter of 0.9% NaCl including 25 mg/m2 cisplatin, 20 mmol of potassium chloride, and 8 nmol of magnesium sulfate over 60 minutes

DRUG

NaCl

Infusion of 500 ml of 0.9% NaCl over 30-minutes

DRUG

BAY80-6964 fixed dose

BAY80-6946 IV infusion at the maximum tolerated dose determined in Treatment A over 60 min. \[If Treatment A MTD is not tolerable, further subject enrollment will begin at one BAY80-6946 Dose Level lower with the cisplatin-gemcitabine doses remaining constant.\]

Trial Locations (3)

33612

Tampa

55905

Rochester

27599-7305

Chapel Hill