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Medical OncologyPhase 1NCT02457351

Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study

A Phase 1 study testing Roniciclib (BAY 1000394) and Itraconazole (Sporanox) in people with Medical Oncology, run by Bayer at 4 sites in Canada.

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

To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients. To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Medical Oncology
What is being tested?
Roniciclib (BAY 1000394) and Itraconazole (Sporanox)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
4 sitesCanada
Study dates
Jul 2015to Apr 2016
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥ 18 years of age with histological or cytological confirmed advanced solid tumors refractory to, or not able to tolerate to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.
  • Adequate liver, renal and bone-marrow functions as assessed by laboratory values.
  • ECOG Performance Status of 0 - 2 and life expectancy of at least 12 weeks.
  • Subject with a history of hypertension should be on a stable anti-hypertensive treatment for more than 7 days prior to the first dose of study drug.

Who cannot join

  • Medical and surgical history:
  • Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism.
  • History of cardiac disease: congestive heart failure, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
  • Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management)
  • Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Active clinically serious infections of Common Terminology Criteria for Adverse Events (CTCAE, v. 4.03) > Grade 2.
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  • Symptomatic metastatic brain or meningeal tumors unless the subject is >3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics).
  • History of organ allograft.
  • Use of strong inhibitors and/or inducers of CYP3A4 in the 14 days before study treatment

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Hamilton, Ontario, L8V 5C2

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of Roniciclib in Patients With Advanced Solid Tumors

To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients.

To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients

Being tested
Roniciclib (BAY 1000394), Itraconazole (Sporanox)
Keywords
Phase 1, Advanced solid tumor, pan-CDK inhibitor, Drug-drug Interaction

What participants receive

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

  • Roniciclib (BAY 1000394)Drug

    Part 1 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 mg Cycle 1 Day 6: Single dose 2.5 mg Part 2 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 or 5 mg (based on Part 1 data) Cycle 1 Day 6: Single dose 2.5 or 5 mg (based on part 1 data)

    Part 1 \& Part 2

    Cycle 2 and subsequent 21-day cycles:

    Day 1-3 of each cycle: 5 mg bid Day 4-7 of each cycle: no dose

  • Itraconazole (Sporanox)Drug

    Part 1 \& Part 2 of Cycle 1 Cycle 1 Day 4: 200 mg bid Cycle 1 Day 5-11: 200 mg qd

Study groups in NCT02457351
Study groupRoleWhat they receive
Roniciclib + ItraconazoleExperimentalPharmacokinetics and safety in patients with advanced solid tumor
Receives: Drug: Roniciclib (BAY 1000394); Drug: Itraconazole (Sporanox)

What is being measured

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

  1. Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 1 (without itraconazole)

    Measured: Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing

  2. Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 1 (without itraconazole)

    Measured: Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing

  3. Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 6 (with itraconazole)

    Measured: Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing

  4. Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 6 (with itraconazole)

    Measured: Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing

Secondary outcomes (8)

  1. Collection of Adverse events as a measure of safety and tolerability of roniciclib dosing when administered with and without itraconazole

    Measured: up to 15 months

  2. Laboratory analyses to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole

    Complete blood count, Complete chemistry panel, Coagulation panel, Virology, Urinalysis, Pregnancy test

    Measured: up to 15 months

  3. Monitoring of vital signs to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole

    Measured: up to 15 months

  4. East Coast Oncology Group (ECOG) performance status to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole

    Measured: up to 15 months

  5. Electrocardiogram (12 lead ECG) readings to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole

    Measured: up to 15 months

  6. Physical examination to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole

    Measured: up to 15 months

  7. Maximum observed drug concentration (Cmax) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole)

    Measured: Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing

  8. Area under the concentration vs. time curve from zero to 24 hr (AUC) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole)

    Measured: Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing

Timeline

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

  1. First posted29 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionFeb 2016
  4. Study completionApr 2016

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02457351
Sponsor's protocol ID
17616
Status last verified
May 2016
First submitted
28 May 2015
Last updated
23 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Roniciclib (BAY 1000394) and Itraconazole (Sporanox) in people with Medical Oncology, run by Bayer at 4 sites in Canada.

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 4 inclusion and 10 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 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. 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?

Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 1 (without itraconazole) (time frame: Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing). The study lists 4 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 NCT02457351.

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 23 May 2016.

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