NSCLC (Non-Small Cell Lung Cancer)Phase 1/2NCT02522910
An Open-label Phase Ib/II Study of BAY 1000394 (Roniciclib) in Combination With Docetaxel in Second- or Third-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing BAY 1000394 (Roniciclib) in combination with docetaxel in people with NSCLC (Non-Small Cell Lung Cancer), run by Yonsei University.
Trial summary
This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3 dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY 1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel in subjects with second- or third-line… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- NSCLC (Non-Small Cell Lung Cancer)
- What is being tested?
- BAY 1000394 (Roniciclib) in combination with docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening must be performed within 14 days prior to the first dose of study drug. Subjects are eligible for inclusion in this study if all of the following criteria are met:
- Histologically or cytologically confirmed stage IIIB or IV NSCLC Patients who received prior 1 or 2 lines of systemic anticancer therapy. For EGFR mutated or ALK rearranged patients, EGFR TKI or ALK inhibitor is also considered a line of systemic therapy
- Documented progressive disease after platinum-containing doublet chemotherapy (Platinum-containing chemotherapy given as an neoadjuvant/adjuvant chemotherapy, or definitive concurrent chemoradiotherapy within 6 months can be considered as one line of chemotherapy)
- For patients who showed non-progressive disease with 1st line platinum-doublet chemotherapy, continuation maintenance therapy is not considered a line of therapy, whereas switch maintenance therapy is considered another line of therapy.
- EGFR mutated or ALK rearranged patients can be eligible after one line of EGFR TKI or ALK inhibitor and platinum-doublet chemotherapy.
- Any prior systemic anticancer therapy must have been completed at least 3 weeks prior to initiation of study medication. Palliative radiation, whole brain radiotherapy (WBRT), or gamma knife surgery (GKS) for brain metastases must have been completed at least 2 weeks prior to initiation of study medication. Major or minor surgery must have been completed at least 4 or 2 weeks prior to initiation of study medication, respectively. Majority or minority of surgery can be decided at the investigator's discretion. Any acute toxicity must have recovered to Grade ≤ 1 (except alopecia).
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- Male or female subjects aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to the first dose of study drug:
- At least one measurable lesion based on RECIST 1.1
- Availability of tumor tissue for molecular analysis is not mandatory (presence of archival tissue or re-biopsy for acquisition of tumor tissue is strongly recommended)
Who cannot join
- Subjects are to be excluded from the study if they display any of the following criteria:
- Prior radiotherapy (local palliative radiotherapy is permitted but must have occurred ≥2 weeks and subject must have no Grade 3 or 4 toxicities prior to first dose of study treatment; palliative is defined as not intended to cure but to relieve symptoms and reduce suffering)
- Eligibility for local therapy (surgery or radiotherapy)
- Previous treatment with any CDK inhibitors or docetaxel
- Current or ongoing administration of anticoagulation or antiplatelet therapy. However, use of low-dose aspirin (≤100 mg/day) and/or low-dose heparin is permitted unless it is being used for conditions other than cancer
- Known hypersensitivity to any of the study treatments or excipients of the preparations or any agent given in association with this study
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- Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism
- History of cardiac disease: Congestive heart failure New York Heart Association (NYHA) Class III or IV angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Active clinically serious infections of NCI-CTCAE v4.0 >Grade 2
- Known human immunodeficiency virus infection, active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy
- Seizure disorder requiring therapy (such as steroids or anti-epileptics)
- Symptomatic metastatic brain or meningeal tumors, including those of the spinal cord, and including cases of neoplastic meningitis (also known as symptomatic carcinomatous meningitis or leptomeningeal carcinomatosis). However, after WBRT or GKS for symptomatic brain or leptomeningeal metastases, if subjects are stable for 2 weeks without steroid and the dosage of anti-convulsant is stable for 2 weeks, they are eligible. Asymptomatic central nervous system metastases are eligible if the subject has no abnormal findings on neurologic examination and is not receiving corticosteroid therapy to control symptoms.
- History of organ allograft
- Evidence or history of bleeding disorder, ie any hemorrhage / bleeding event of NCI-CTCAE v4.0 >Grade 2 within 4 weeks prior to the first dose of study treatment
- Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management)
- Serious, non-healing wound, ulcer, or bone fracture (bone fractures due to bone metastases are acceptable)
About this study
This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3 dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY 1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel in subjects with second- or third-line NSCLC.
Read the detailed description
This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3 dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY 1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel in subjects with second- or third-line NSCLC.
The number of subjects treated in the dose-escalation part depends on the number of dose- escalation or de-escalation steps needed to determine the MTD of BAY 1000394 (Roniciclib) in combination with docetaxel in this subject population.
Subjects treated at the recommended phase II dose level within the Phase Ib part of the study will be included in the response evaluation of the Phase II part.
- Conditions
- NSCLC (Non-Small Cell Lung Cancer)
- Being tested
- BAY 1000394 (Roniciclib) in combination with docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 1000394 (Roniciclib) in combination with docetaxelDrug
The study (Phase Ib part and Phase II part) will be conducted as a single center study. This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3 dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY 1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel in subjects with second- or third-line NSCLC.
| Study group | Role | What they receive |
|---|---|---|
| Roniciclib with Docetaxel | Experimental | Not described Receives: Drug: BAY 1000394 (Roniciclib) in combination with docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Determination of the maximum tolerated dose (MTD) of BAY 1000394 (Roniciclib) in combination with docetaxel.
Measured: 4 months after the study enrollment
Dose-Limiting Toxicities (DLT)
Determination of the dose-limiting toxicities (DLT) of BAY 1000394 (Roniciclib) in combination with docetaxel.
Measured: 4 months after the study enrollment
Progression-Free Survival (PFS)
Evaluation of the progression-free survival (PFS) at 4 months by RECIST 1.1 criteria.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-Small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522910
- Sponsor's protocol ID
- 4-2015-0274
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase Ib/II Study of BAY 1000394 (Roniciclib) in Combination With Docetaxel in Second- or Third-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02522910
- Acronym / sponsor ID
- 4-2015-0274
- Conditions
- NSCLC (Non-Small Cell Lung Cancer)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3 dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY 1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel in subjects with second- or third-line NSCLC.
Detailed description
This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3 dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY 1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel in subjects with second- or third-line NSCLC.
The number of subjects treated in the dose-escalation part depends on the number of dose- escalation or de-escalation steps needed to determine the MTD of BAY 1000394 (Roniciclib) in combination with docetaxel in this subject population.
Subjects treated at the recommended phase II dose level within the Phase Ib part of the study will be included in the response evaluation of the Phase II part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roniciclib with Docetaxel | Experimental | Drug: BAY 1000394 (Roniciclib) in combination with docetaxel |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Screening must be performed within 14 days prior to the first dose of study drug. Subjects are eligible for inclusion in this study if all of the following criteria are met:
- Histologically or cytologically confirmed stage IIIB or IV NSCLC Patients who received prior 1 or 2 lines of systemic anticancer therapy. For EGFR mutated or ALK rearranged patients, EGFR TKI or ALK inhibitor is also considered a line of systemic therapy
- Documented progressive disease after platinum-containing doublet chemotherapy (Platinum-containing chemotherapy given as an neoadjuvant/adjuvant chemotherapy, or definitive concurrent chemoradiotherapy within 6 months can be considered as one line of chemotherapy)
- For patients who showed non-progressive disease with 1st line platinum-doublet chemotherapy, continuation maintenance therapy is not considered a line of therapy, whereas switch maintenance therapy is considered another line of therapy.
- EGFR mutated or ALK rearranged patients can be eligible after one line of EGFR TKI or ALK inhibitor and platinum-doublet chemotherapy.
Key exclusion criteria (16 listed)
- Prior radiotherapy (local palliative radiotherapy is permitted but must have occurred ≥2 weeks and subject must have no Grade 3 or 4 toxicities prior to first dose of study treatment; palliative is defined as not intended to cure but to relieve symptoms and reduce suffering)
- Eligibility for local therapy (surgery or radiotherapy)
- Previous treatment with any CDK inhibitors or docetaxel
- Current or ongoing administration of anticoagulation or antiplatelet therapy. However, use of low-dose aspirin (≤100 mg/day) and/or low-dose heparin is permitted unless it is being used for conditions other than cancer
- Known hypersensitivity to any of the study treatments or excipients of the preparations or any agent given in association with this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY 1000394 (Roniciclib) in combination with docetaxelThe study (Phase Ib part and Phase II part) will be conducted as a single center study. This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3 dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY 1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel in subjects with second- or third-line NSCLC. | Drug | Roniciclib with Docetaxel |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 4 months after the study enrollment
Determination of the maximum tolerated dose (MTD) of BAY 1000394 (Roniciclib) in combination with docetaxel.
Dose-Limiting Toxicities (DLT)
Time frame: 4 months after the study enrollment
Determination of the dose-limiting toxicities (DLT) of BAY 1000394 (Roniciclib) in combination with docetaxel.
Progression-Free Survival (PFS)
Time frame: 4 months
Evaluation of the progression-free survival (PFS) at 4 months by RECIST 1.1 criteria.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BAY 1000394 (Roniciclib) in combination with docetaxel in people with NSCLC (Non-Small Cell Lung Cancer), run by Yonsei University.
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 11 inclusion and 16 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: withdrawn, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 Tolerated Dose (MTD) (time frame: 4 months after the study enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2016.