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NeoplasmsPhase 1NCT01404390

Japanese BAY80-6946 Monotherapy Phase I Study

A Phase 1 study testing BAY80-6946 in people with Neoplasms, run by Bayer at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be conducted as an open label, single centre, Phase I study of PI3K (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or refractory solid tumours. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Neoplasms
What is being tested?
BAY80-6946
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteJapan
Study dates
18 Aug 2011to 12 Jul 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cancer patients
  • Japanese patients, who are at least 20 years of age
  • Histological or cytological documentation of non-hematologic, malignant solid tumours, excluding primary brain or spinal tumours, with no past or current involvement in the central nervous system (CNS)
  • At least one measurable lesion or evaluable disease according to RECIST (version 1.1)
  • Eastern Cooperative Oncology performance status (ECOG-PS) of 0 or 1
  • Life expectancy of at least 12 weeks
  • Advanced or refractory solid tumours not amenable to standard therapy, at the first screening examination/visit

Who cannot join

  • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of first study treatment. Patients must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy by the investigator (with the exception of alopecia).
  • Radiotherapy to target lesions during study or within 4 weeks of first study treatment
  • Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment
  • Current diagnosis of Type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, and/or HbA1c>/= 6.5%
  • Past and current histories of cardiac disease congestive heart failure > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset of angina within 3 months prior to study entry or unstable angina or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
  • Active and clinically serious infections >Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03)
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  • Uncontrolled hypertension defined as systolic blood pressure >150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
  • Patients undergoing renal dialysis
  • Pregnant or breast feeding women

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Kashiwa, Chiba, 277-8577

Other trials in Japan

About this study

Official title: An Open Label, Single Centre, Phase I Study of PI3K Inhibitor BAY80-6946 to Evaluate the Safety, Tolerability and Pharmacokinetics in Japanese Patients With Advanced or Refractory Solid Tumours

This study will be conducted as an open label, single centre, Phase I study of PI3K (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8 and Day 15 with three weeks on and one week off in each treatment cycle.

Conditions
Neoplasms
Being tested
BAY80-6946
Keywords
Phase I, Japanese
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY80-6946Drug

    0.4mg/ kg, iv, day 1,8 and 15, every 28 days

  • BAY80-6946Drug

    0.8mg/ kg, iv, day 1,8 and 15, every 28 days

Study groups in NCT01404390
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: BAY80-6946
Arm 2ExperimentalNot described
Receives: Drug: BAY80-6946

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse events

    Measured: 169 days

  2. Maximum drug concentration in plasma after single dose administration (Cmax)

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15

  3. Cmax divided by dose (mg) per kg body weight (Cmax,norm)

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15

  4. Cmax divided by dose (mg) (Cmax/D)

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15

  5. Area under the concentration-time curve time 0 to 8 hours (AUC(0-8))

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15

  6. Area under the concentration-time curve from time 0 to 25 hours (AUC(0-25))

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15

  7. AUC(0-25) divided by dose (mg) per kg body weight (AUC(0-25)norm)

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15

  8. AUC(0-25) divided by dose (mg) (AUC(0-25)/D)

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15

  9. AUC from time 0 to last data point (AUC(0-tlast))

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15

  10. Time to maximum drug concentration in plasma (tmax)

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day 15

Secondary outcomes (13)

  1. Area under the plasma concentration-time curve of (AUC) of BAY80-6946

    Measured: 0 - 168 hours in Cycle1 Day1

  2. Half-life associated with terminal slope of drug in plasma (t1/2)

    Measured: 0 - 168 hours in Cycle1 Day1

  3. Mean residence time of drug in plasma (MRT)

    Measured: 0 - 168 hours in Cycle1 Day1

  4. Total body clearance of drug from plasma (CL)

    Measured: 0 - 168 hours in Cycle1 Day1

  5. Volume of drug distribution during terminal phase after single dose administration (Vz)

    Measured: 0 - 168 hours in Cycle1 Day1

  6. Volume of drug distribution during steady state after single dose administration (Vss)

    Measured: 0 - 168 hours in Cycle1 Day1

  7. Accumulation ratio calculated from AUC(0-8) after multiple dosing and AUC(0-8) after single dosing (RAAUC(0-8))

    Measured: 0 - 8 hours in Cycle3 Day15

  8. Accumulation ratio calculated from AUC(0-25) after multiple dosing and AUC(0-25) after single dosing (RAAUC(0-25))

    Measured: 0 - 25 hours in Cycle1 Day15

  9. Accumulation ration calculated from Cmax after multiple dosing and Cmax after single dosing (RACmax)

    Measured: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15

  10. Overall tumor response rate

    Proportion of subjects with confirmed complete and partial response

    Measured: 176 days

  11. Overall disease control rate

    Proportion of subjects who had a best response rating of complete response, partial response or stable disease

    Measured: 176 days

  12. Time to progression of cancer growth

    Measured: 176 days

  13. Progression-free survival time

    Measured: 176 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2011 (estimated)
  2. Study start18 Aug 2011
  3. Primary completion22 Mar 2012
  4. Study completion12 Jul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01404390
Sponsor's protocol ID
15205
Status last verified
Dec 2017
First submitted
27 Jul 2011
Last updated
14 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • Doi T, Fuse N, Yoshino T, Kojima T, Bando H, Miyamoto H, Kaneko M, Osada M, Ohtsu A. A Phase I study of intravenous PI3K inhibitor copanlisib in Japanese patients with advanced or refractory solid tumors. Cancer Chemother Pharmacol. 2017 Jan;79(1):89-98. doi: 10.1007/s00280-016-3198-0. Epub 2016 Dec 3.

    PubMed 27915408

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY80-6946 in people with Neoplasms, run by Bayer at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with adverse events (time frame: 169 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01404390, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017; AzTrials last refreshed its copy on 31 Oct 2026.

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