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Completed

NCT Number: NCT02155582

Copanlisib Pharmacodynamic Study

This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.

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Key information

Conditions

Non Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bruxelles - Brussel, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Histologically confirmed diagnosis of the following NHL: follicular lymphoma all grades, lymphoplasmacytic lymphoma / Waldenström macroglobulinemia, transformed indolent lymphoma, diffuse large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma, or peripheral T-cell lymphoma, relapsed or refractory, with 1 or more prior chemo-immunotherapy- or immunotherapy-based regimen(s) OR
  • Advanced and / or refractory solid tumors with high prevalence (≥30%) of PIK3CA or PTEN alteration: Breast and uterine cancers (endometrium cancers but also non-endometrial uterine cancers), lung (squamous cell only), cervical, head and neck, prostate, and ovarian cancers
  • Biopsy-accessible tumor
  • Male or female patients equal 18 or more years of age
  • NHL patients must have at least 1 bi-dimensionally measurable lesion according to the modified Cheson criteria. Patients with solid tumors must have at least 1 solid tumor lesion measurable by computed tomography or magnetic resonance imaging according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria
  • Eastern Cooperative Oncology Group performance status 2 or <
  • Life expectancy of at least 3 months
  • Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements conducted within 7 days before the first dose of study drug
  • Left ventricular ejection fraction > or equal the lower limit of normal for the institution

Exclusion criteria

  • Previous or concurrent cancer that is distinct in primary site or histology from NHL or the solid tumor, for which the patient is enrolled into this study, within 5 years before treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, in situ breast cancer, in situ prostate carcinoma if Gleason score < or equal to 6 and prostate-specific antigen <10 ng/mL, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]
  • Known lymphomatous involvement of the brain or leptomeningeal involvement; solid tumor patients with central nervous system (CNS) metastases if treatment completed <3 months before enrollment or lesions unstable or progressing on magnetic resonance imaging scans performed within 1 month of enrollment or unstable symptoms of the CNS metastases
  • Any illness or medical condition that is unstable or could jeopardize the safety of the patient or his / her compliance in the study
  • Current diagnosis of type 1 or type 2 diabetes mellitus with HbA1c < or equal to 8.5% or fasting blood glucose < or equal to 160 mg/dL

Treatment and study plan

Copanlisib (BAY80-6946)

Drug

0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients;45 mg and 60 mg for the diabetic patients; Intravenous (IV) infusion over 1 hour. Dosing of copanlisib will be on Days 1, 8, and 15 of each 28 day treatment cycle.

Primary outcomes

  1. Maximum change from baseline in expression of pathway inhibition (pAKT) in surrogate tissue (platelet rich plasma) during copanlisib monotherapy

    Time frame: Baseline and approximately 2 years

  2. Maximum change from baseline in plasma glucose during 2 cycles of copanlisib monotherapy

    Time frame: Baseline and after day 22

Secondary outcomes

  1. AUC(0-168) of copanlisib after each copanlisib IV infusion during 2 cycles of copanlisib monotherapy

    Time frame: After day 22

  2. AEs as characterized by type, frequency, severity (as graded by CTCAE) and relationship to study drug

    Time frame: Approximately 2 years

  3. Maximum change from baseline in insulin during 2 cycles of copanlisib

    Time frame: After day 22

  4. Maximum change from baseline in C-peptide during 2 cycles of copanlisib

    Time frame: After day 22

  5. FDG PET early response (decreased SUVmax compared to baseline) after dosing with copanlisib for non-diabetic patients with detectable FDG tumor uptake at baseline

    Time frame: After day 22

  6. Change from baseline in expression and / or phosphorylation of PI3K pathway proteins in paired tumor biopsies

    Time frame: Baseline and after day 22

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Phase I Pharmacodynamic Study of Copanlisib (BAY 80-6946) as Monotherapy in Patients With Non-Hodgkin's Lymphoma and Solid Tumors

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 4, 2014
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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