Non-Squamous Non-Small Cell Lung CancerPhase 1NCT01702714
A Study of RO5083945 in Combination With Cisplatin and Gemcitabine or Carboplatin and Paclitaxel in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer of Squamous Histology Who Have Not Received Prior Chemotherapy for The Metastatic Disease
A Phase 1 study testing RO5083945, carboplatin and cisplatin in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche.
Trial summary
This open-label, multicenter, non-randomized, dose-escalating phase Ib study with an expansion cohort will determine the recommended Phase II dose and schedule to investigate safety, tolerability, and activity of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- RO5083945, carboplatin and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Feb 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
- Adult patients, >/= 18 years of age
- Locally advanced (stage IIIB, excluding patients who are candidates for chemo-radiotherapy or radical thoracic radiotherapy), metastatic (stage IV) or recurrent squamous non-small cell lung cancer (NSCLC)
- Histologically documented squamous NSCLC. Mixed tumors should be categorized according to the predominant cell type
- Histological tumor tissue sample from initial diagnosis or new tumor biopsy representative of the disease
- Patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 3 months prior to enrollment
- At least one measurable disease lesion as per RECIST 1.1 criteria
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate hematological, liver and renal function
- Females of childbearing potential must commit to using a reliable and appropriate method of contraception until at least 3 months after the end of the last dose of study treatment
Who cannot join
- Prior chemotherapy (excluding neoadjuvant/adjuvant chemotherapy/chemo-radiotherapy) or treatment with another systemic anti-cancer agent (e.g. monoclonal antibody, tyrosine kinase inhibitor)
- Radiotherapy within the last 4 weeks prior to first dosing, except for limited field palliative radiotherapy for bone pain relief
- Treatment with any other investigational agent within 30 days prior to starting study treatment or participation in another clinical trial (e.g. CTC blood collection) within 7 days prior to starting study treatment
- Historical or clinical evidence of central nervous system (CNS) metastases (except for previously treated CNS metastases in patients that are asymptomatic, have had no evidence of active CNS metastases for >/= 3 months prior to first dose and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days)
- Recent history of poorly controlled hypertension (systolic >180 mmHg or diastolic >100 mmHg)
- Severe uncontrolled illness, including poorly controlled diabetes mellitus and active or uncontrolled infection
- Hypersensitivity to the active substance or to any excipients or to any of the study drugs including premedication (corticosteroids, anti-histamine, paracetamol)
- Pregnant or breastfeeding women
About this study
Official title: A MULTICENTER, OPEN-LABEL PHASE IB STUDY OF RO5083945 IN COMBINATION WITH CISPLATIN AND GEMCITABINE OR CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH ADVANCED OR RECURRENT NON SMALL CELL LUNG CANCER OF SQUAMOUS HISTOLOGY WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR THE METASTATIC DISEASE.
This open-label, multicenter, non-randomized, dose-escalating phase Ib study with an expansion cohort will determine the recommended Phase II dose and schedule to investigate safety, tolerability, and activity of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel in patients with advanced or recurrent non-small cell lung cancer of squamous histology who have not received prior chemotherapy for the metastatic disease. Cohorts of patients will receive escalating doses of RO5083945 in combination with up to 6 cycles of cisplatin and gemcitabine or carboplatin and paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- RO5083945, carboplatin, cisplatin, gemcitabine, paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5083945Drug
multiple ascending doses
carboplatinDrug
up to 6 cycles
cisplatinDrug
up to 6 cycles
gemcitabineDrug
up to 6 cycles
paclitaxelDrug
up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| RO5083945 + carboplatin + paclitaxel | Experimental | Not described Receives: Drug: RO5083945; Drug: carboplatin; Drug: paclitaxel |
| RO5083945 + cisplatin +gemcitabine | Experimental | Not described Receives: Drug: RO5083945; Drug: cisplatin; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Measured: approximately 1.5 years
Recommended phase II dose (RP2D) of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Measured: approximately 1.5 years
Secondary outcomes (9)
Safety: Incidence of adverse events
Measured: approximately 1.5 years
Pharmacokinetics: Serum concentrations of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Measured: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of cisplatin
Measured: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of gemcitabine
Measured: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of carboplatin
Measured: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of paclitaxel
Measured: up to 18 weeks
Preliminary evidence of antitumor activity: Objective response rate (complete response, partial response and stable disease)
Measured: approximately 1.5 years
Duration of response
Measured: approximately 1.5 years
Biomarker assessments : Immune effector cells/EGFR markers
Measured: up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startJul 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Why it stopped: Project Team decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702714
- Sponsor's protocol ID
- BP28577
- Other IDs
- 2012-003376-39
- Status last verified
- Nov 2016
- First submitted
- 1 Oct 2012
- Last updated
- 4 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTICENTER, OPEN-LABEL PHASE IB STUDY OF RO5083945 IN COMBINATION WITH CISPLATIN AND GEMCITABINE OR CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH ADVANCED OR RECURRENT NON SMALL CELL LUNG CANCER OF SQUAMOUS HISTOLOGY WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR THE METASTATIC DISEASE.
- ClinicalTrials.gov ID
- NCT01702714
- Acronym / sponsor ID
- BP28577
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project Team decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 8 Oct 2012 (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 open-label, multicenter, non-randomized, dose-escalating phase Ib study with an expansion cohort will determine the recommended Phase II dose and schedule to investigate safety, tolerability, and activity of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel in patients with advanced or recurrent non-small cell lung cancer of squamous histology who have not received prior chemotherapy for the metastatic disease. Cohorts of patients will receive escalating doses of RO5083945 in combination with up to 6 cycles of cisplatin and gemcitabine or carboplatin and paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RO5083945 + carboplatin + paclitaxel | Experimental | Drug: RO5083945, Drug: carboplatin, Drug: paclitaxel |
| RO5083945 + cisplatin +gemcitabine | Experimental | Drug: RO5083945, Drug: cisplatin, Drug: gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients, >/= 18 years of age
- Locally advanced (stage IIIB, excluding patients who are candidates for chemo-radiotherapy or radical thoracic radiotherapy), metastatic (stage IV) or recurrent squamous non-small cell lung cancer (NSCLC)
- Histologically documented squamous NSCLC. Mixed tumors should be categorized according to the predominant cell type
- Histological tumor tissue sample from initial diagnosis or new tumor biopsy representative of the disease
- Patients who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 3 months prior to enrollment
Key exclusion criteria (8 listed)
- Prior chemotherapy (excluding neoadjuvant/adjuvant chemotherapy/chemo-radiotherapy) or treatment with another systemic anti-cancer agent (e.g. monoclonal antibody, tyrosine kinase inhibitor)
- Radiotherapy within the last 4 weeks prior to first dosing, except for limited field palliative radiotherapy for bone pain relief
- Treatment with any other investigational agent within 30 days prior to starting study treatment or participation in another clinical trial (e.g. CTC blood collection) within 7 days prior to starting study treatment
- Historical or clinical evidence of central nervous system (CNS) metastases (except for previously treated CNS metastases in patients that are asymptomatic, have had no evidence of active CNS metastases for >/= 3 months prior to first dose and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days)
- Recent history of poorly controlled hypertension (systolic >180 mmHg or diastolic >100 mmHg)
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 |
|---|---|---|
| RO5083945multiple ascending doses | Drug | RO5083945 + carboplatin + paclitaxel, RO5083945 + cisplatin +gemcitabine |
| carboplatinup to 6 cycles | Drug | RO5083945 + carboplatin + paclitaxel |
| cisplatinup to 6 cycles | Drug | RO5083945 + cisplatin +gemcitabine |
| gemcitabineup to 6 cycles | Drug | RO5083945 + cisplatin +gemcitabine |
| paclitaxelup to 6 cycles | Drug | RO5083945 + carboplatin + paclitaxel |
Primary outcome
Maximum tolerated dose in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Time frame: approximately 1.5 years
Recommended phase II dose (RP2D) of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Time frame: approximately 1.5 years
9 secondary outcomes
Safety: Incidence of adverse events
Time frame: approximately 1.5 years
Pharmacokinetics: Serum concentrations of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Time frame: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of cisplatin
Time frame: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of gemcitabine
Time frame: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of carboplatin
Time frame: up to 18 weeks
Pharmacokinetics: Effect of RO5083945 on serum concentrations of paclitaxel
Time frame: up to 18 weeks
Preliminary evidence of antitumor activity: Objective response rate (complete response, partial response and stable disease)
Time frame: approximately 1.5 years
Duration of response
Time frame: approximately 1.5 years
Biomarker assessments : Immune effector cells/EGFR markers
Time frame: up to 18 weeks
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 4 Nov 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.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5083945, carboplatin and cisplatin in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche.
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 9 inclusion and 8 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 4 Nov 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 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 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 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel (time frame: approximately 1.5 years). The study lists 2 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 4 Nov 2016.