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

This study has suspended participant recruitment.
(Project Team decision)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01702714
First received: October 1, 2012
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: RO5083945
Drug: cisplatin
Drug: gemcitabine
Drug: carboplatin
Drug: paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Maximum tolerated dose in combination with cisplatin and gemcitabine or carboplatin and paclitaxel [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Recommended phase II dose (RP2D) of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Serum concentrations of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Effect of RO5083945 on serum concentrations of cisplatin [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Effect of RO5083945 on serum concentrations of gemcitabine [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Effect of RO5083945 on serum concentrations of carboplatin [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Effect of RO5083945 on serum concentrations of paclitaxel [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
  • Preliminary evidence of antitumor activity: Objective response rate (complete response, partial response and stable disease) [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Biomarker assessments : Immune effector cells/EGFR markers [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: August 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO5083945 + cisplatin +gemcitabine Drug: RO5083945
multiple ascending doses
Drug: cisplatin
up to 6 cycles
Drug: gemcitabine
up to 6 cycles
Experimental: RO5083945 + carboplatin + paclitaxel Drug: RO5083945
multiple ascending doses
Drug: carboplatin
up to 6 cycles
Drug: paclitaxel
up to 6 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702714

Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01702714     History of Changes
Other Study ID Numbers: BP28577, 2012-003376-39
Study First Received: October 1, 2012
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 20, 2014