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

NCT01702714 | Withdrawn Phase 1

• 2 other identifiers: BP285772012-003376-39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose in combination with cisplatin and gemcitabine or carboplatin and paclitaxel

  approximately 1.5 years

• Recommended phase II dose (RP2D) of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel

  approximately 1.5 years

Secondary Outcomes (9)

• Safety: Incidence of adverse events

  approximately 1.5 years

• Pharmacokinetics: Serum concentrations of RO5083945 in combination with cisplatin and gemcitabine or carboplatin and paclitaxel

  up to 18 weeks

• Pharmacokinetics: Effect of RO5083945 on serum concentrations of cisplatin

  up to 18 weeks

• Pharmacokinetics: Effect of RO5083945 on serum concentrations of gemcitabine

  up to 18 weeks

• Pharmacokinetics: Effect of RO5083945 on serum concentrations of carboplatin

  up to 18 weeks

Study Arms (2)

RO5083945 + carboplatin + paclitaxel

EXPERIMENTAL

Drug: RO5083945; Drug: carboplatin; Drug: paclitaxel

RO5083945 + cisplatin +gemcitabine

EXPERIMENTAL

Drug: RO5083945; Drug: cisplatin; Drug: gemcitabine

Interventions

RO5083945 DRUG

multiple ascending doses

RO5083945 + carboplatin + paclitaxel; RO5083945 + cisplatin +gemcitabine

carboplatin DRUG

up to 6 cycles

RO5083945 + carboplatin + paclitaxel

cisplatin DRUG

up to 6 cycles

RO5083945 + cisplatin +gemcitabine

gemcitabine DRUG

up to 6 cycles

RO5083945 + cisplatin +gemcitabine

paclitaxel DRUG

up to 6 cycles

RO5083945 + carboplatin + paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Interventions

imgatuzumab; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 8, 2012
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-11