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
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
RO5083945
carboplatin
cisplatin
gemcitabine
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RO5083945 + carboplatin + paclitaxel
RO5083945 + cisplatin +gemcitabine
Arm Description
Outcomes
Primary Outcome Measures
Maximum tolerated dose in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Recommended phase II dose (RP2D) of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Secondary Outcome Measures
Safety: Incidence of adverse events
Pharmacokinetics: Serum concentrations of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Pharmacokinetics: Effect of RO5083945 on serum concentrations of cisplatin
Pharmacokinetics: Effect of RO5083945 on serum concentrations of gemcitabine
Pharmacokinetics: Effect of RO5083945 on serum concentrations of carboplatin
Pharmacokinetics: Effect of RO5083945 on serum concentrations of paclitaxel
Preliminary evidence of antitumor activity: Objective response rate (complete response, partial response and stable disease)
Duration of response
Biomarker assessments : Immune effector cells/EGFR markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01702714
Brief Title
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
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Project Team decision
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RO5083945 + carboplatin + paclitaxel
Arm Type
Experimental
Arm Title
RO5083945 + cisplatin +gemcitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RO5083945
Intervention Description
multiple ascending doses
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
up to 6 cycles
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
up to 6 cycles
Primary Outcome Measure Information:
Title
Maximum tolerated dose in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Time Frame
approximately 1.5 years
Title
Recommended phase II dose (RP2D) of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Time Frame
approximately 1.5 years
Secondary Outcome Measure Information:
Title
Safety: Incidence of adverse events
Time Frame
approximately 1.5 years
Title
Pharmacokinetics: Serum concentrations of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel
Time Frame
up to 18 weeks
Title
Pharmacokinetics: Effect of RO5083945 on serum concentrations of cisplatin
Time Frame
up to 18 weeks
Title
Pharmacokinetics: Effect of RO5083945 on serum concentrations of gemcitabine
Time Frame
up to 18 weeks
Title
Pharmacokinetics: Effect of RO5083945 on serum concentrations of carboplatin
Time Frame
up to 18 weeks
Title
Pharmacokinetics: Effect of RO5083945 on serum concentrations of paclitaxel
Time Frame
up to 18 weeks
Title
Preliminary evidence of antitumor activity: Objective response rate (complete response, partial response and stable disease)
Time Frame
approximately 1.5 years
Title
Duration of response
Time Frame
approximately 1.5 years
Title
Biomarker assessments : Immune effector cells/EGFR markers
Time Frame
up to 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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