Status:
COMPLETED
A Study of RO5509554 as Monotherapy and in Combination With Paclitaxel in Participants With Advanced Solid Tumors
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This open-label, multicenter, dose-escalation study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5509554 in participants with advanced solid tumors which are not am...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced and/or metastatic solid tumors which are not amenable to standard therapy, with exceptions as defined in exclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease according to RECIST criteria version 1.1
- Adequate bone marrow, cardiac, liver and renal function
Exclusion
- Participants with histologically proven Hepatocellular Carcinoma (HC), Non Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), gastric cancer, malignant melanoma, nonmetastatic and locally controlled PVNS/TGCT
- Participants with known auto-immune disease
- Known or suspected central nervous system (CNS) metastases including leptomeningeal metastasis; participants with radiologically stable, asymptomatic previously irradiated lesion are eligible provided participant is greater than or equal to (\>/=) 4 weeks beyond completing cranial irradiation and \>/= 3 weeks of corticosteroid therapy
- Significant, uncontrolled concomitant diseases, including significant cardiovascular or pulmonary disease
- Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy for bone pain), any investigational agent or immunotherapy within 28 days of first receipt of study drug
- Prior corticosteroids as anti-cancer therapy within minimum of 14 days of first receipt of study drug
- Poorly controlled type 1 or type 2 diabetes mellitus
- Prior toxicities from chemotherapy or radiotherapy which have not regressed to Grade less than or equal to (\</=) 1 severity National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 or later versions
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection
- Pulmonary embolism or any other thrombo-embolic event within 6 months prior to study entry
- History of hematological malignancy within the last 5 years prior to study entry
- Participant requires high dose corticosteroid treatment ( i.e. greater than (\>) 20 mg dexamethasone a day or equivalent for \> 7 consecutive days)
- Any surgical procedure, including the required baseline tumor biopsy, within less than 14 days of first receipt of study drug. Major surgery within 28 days of first receipt of study drug
- Pregnant or lactating women
Key Trial Info
Start Date :
December 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2018
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT01494688
Start Date
December 20 2011
End Date
February 7 2018
Last Update
March 16 2018
Active Locations (7)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States, 19104
3
Institut Bergonie; Oncologie
Bordeaux, France, 33076
4
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France, 69373