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Small Cell Lung CarcinomaPhase 1/2NCT01573338

Clinical Study to Evaluate the Maximum Tolerated Dose of BAY1000394 When Given Together With Chemotherapy and the Effectiveness of This Combination Treatment in Shrinking a Specific Type of Lung Tumors (Small Cell Lung Cancer)

A Phase 1/2 study testing Roniciclib (BAY1000394), Etoposide and Cisplatin in people with Small Cell Lung Carcinoma, run by Bayer at 8 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Roniciclib (BAY1000394), Etoposide and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
8 sitesin 3 countries
Study dates
25 Feb 2013to 23 Jun 2016
Phase
Phase 1/2
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 subjects aged >/=18 years
  • Histologically or cytologically confirmed, extensive disease SCLC
  • At least 1 solid tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1. Subjects with non-measurable disease according to RECIST 1.1 can be included in the Phase Ib part of the study
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  • Life expectancy of at least 12 weeks
  • Serum sodium >/=130 mmol/L

Who cannot join

  • Prior systemic anticancer therapy
  • Prior radiotherapy (local palliative radiotherapy is permitted)
  • History of cardiac disease: congestive heart failure > NYHA Class II, unstable angina (anginal symptoms at rest), any episodes of angina or history of myocardial infarction, cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), previous venous or arterial thrombotic events, pulmonary embolism
  • Moderate or severe hepatic impairment, ie Child-Pugh class B or C
  • Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

United States3 sites

  • Study site

    Buffalo, New York, 14263-0001

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    St Louis, Missouri, 63110

Other trials in United States

France3 sites

  • Study site

    Caen, 14033

  • Study site

    Marseille, 13005

  • Study site

    Villejuif, 94805

Other trials in France

South Korea2 sites

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 03722

Other trials in South Korea

About this study

Official title: Phase Ib / II Study of BAY 1000394 in Combination With Cisplatin / Etoposide or Carboplatin / Etoposide as First-line Therapy in Subjects With Extensive Disease Small Cell Lung Cancer

This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Different groups of patients will receive different dosages of BAY1000394 to determine the safety and maximum tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy is the standard dose usually administered and will not change.

The study will also assess how the drug is metabolized by the body and changes in tumor size.

BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.

Being tested
Roniciclib (BAY1000394), Etoposide, Cisplatin, Carboplatin
Keywords
Cyclin dependent kinases, Drug therapy, combination, Small cell lung carcinoma, Etoposide, Cisplatin, Carboplatin
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • Roniciclib (BAY1000394)Drug

    oral administration twice daily in a 3 days on/ 4 days off schedule. Starting dose will be 2.5 mg bid and dose will be escalated or de-escalated depending on dose limiting toxicity.

  • EtoposideDrug

    100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.

  • CisplatinDrug

    75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.

  • CarboplatinDrug

    Carboplatin will be administered IV on Day 1 of each 21 day cycle. The dose of carboplatin will be determined for each cycle using the Calvert's formula, to yield an AUC of 5 (mg/mL) • min.

Study groups in NCT01573338
Study groupRoleWhat they receive
Arm 1ExperimentalBAY1000394 will be administered in combination with chemotherapy (etoposide and cisplatin or carboplatin) for up to 6 cycles. BAY1000394 will continue beyond Cycle 6 of chemotherapy. Type of chemotherapy for each patient will be decided by the investigator case by case.
Receives: Drug: Roniciclib (BAY1000394); Drug: Etoposide; Drug: Cisplatin; Drug: Carboplatin

What is being measured

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

  1. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Measured: up to 3 years

  2. tumor response - number of subjects with best tumor response that is achieved during or within 30 days after end of therapy

    Measured: up to 3 years

  3. Maximum Tolerated Dose (MTD) - measured by adverse event profile at the end of Cycle 1. MTD will be the highest dose level achieved during dose escalation where non or 1 of 6 subjects experience a dose limiting toxicity as defined in the protocol

    Measured: up to 3 years

  4. Maximum drug concentration in plasma after single dose administration(Cmax) of BAY1000394

    Measured: Cycle 1, Day 8 and Cycle 2, Day 1

  5. Area under the concentration versus time curve from zero to infinity after single (first) dose(AUC) of BAY1000394

    Measured: Cycle 1, Day 8 and Cycle 2, Day 1

Secondary outcomes (6)

  1. Disease control rate (DCR)

    number of patients with complete response, partial response or stable disease according to RECIST

    Measured: From start of treatment of the first subject until 3 years later, assessed every 6 weeks

  2. Overall survival (OS)

    time (days) from date of first treatment to death due to any cause.

    Measured: From start of treatment of the first subject until 3 years later

  3. Time to progression (TTP)

    time (days) from date of first treatment to first observed radiological disease progression

    Measured: From start of treatment of the first subject until 3 years later, assessed every 6 weeks

  4. Progression-free survival (PFS)

    time (days) from date of first treatment to first observed radiological disease progression or death

    Measured: From start of treatment of the first subject until 3 years later, assessed every 6 weeks

  5. Duration of response (DOR)

    time (days) from date of first radiological response to the date that progressive disease is first radiologically documented or death occurs

    Measured: From start of treatment of the first subject until 3 years later, assessed every 6 weeks

  6. Stable disease (SD)

    time (days) from date of first treatment to first observed radiological disease progression or death

    Measured: From start of treatment of the first subject until 3 years later, assessed every 6 weeks

Timeline

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

  1. First posted9 Apr 2012 (estimated)
  2. Study start25 Feb 2013
  3. Primary completion25 Mar 2016
  4. Study completion23 Jun 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01573338
Sponsor's protocol ID
14858
Other IDs
2011-004155-39
Status last verified
Apr 2021
First submitted
5 Apr 2012
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Roniciclib (BAY1000394), Etoposide and Cisplatin in people with Small Cell Lung Carcinoma, run by Bayer at 8 sites in 3 countries.

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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, France, South Korea. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early. Results are not available in the source record.

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?

Safety variables will be summarized using descriptive statistics based on adverse events collection (time frame: up to 3 years). The study lists 5 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 NCT01573338.

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 8 Apr 2021.

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