An Extension Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2016-005189-75-ES
• Date of registration: 04/07/2017
• Prospective Registration: Yes
• Primary sponsor: Roche Farma S.A(Soc.Unipersonal) que realiza el ensayo en España y que actúa como representante de F.Hoffmann-La Roche
• Public title: An Extension Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study
• Scientific title: AN OPEN-LABEL, MULTICENTER EXTENSION STUDY IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH- AND/OR F. HOFFMANN LA ROCHE LTD-SPONSORED ATEZOLIZUMAB STUDY
• Date of first enrolment: 06/07/2017
• Target sample size: 556
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-005189-75
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, Czech Republic, El Salvador, France, Georgia, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovenia, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or
Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study
- First dose of study treatment in the extension study will be received within the treatment interruption period allowed by the parent study
- Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator
- Able to comply with the extension study, in the investigator's judgment
- Will comply with contraception criteria detailed in the designated Reference Safety Information (RSI)
- Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 278
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 278

Exclusion criteria:
- Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
- Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period allowed in the parent study. If the interruption period is beyond the period allowed by the parent study, the acceptable length of interruption will depend on an agreement between the investigator and the Medical
Monitor of the extension study.
- Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade <= 1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the patient at high risk for treatment-related complications
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
- Pregnant or lactating, or intending to become pregnant during the extension study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Cancer (Future parent protocols may include other cancer that are not included in this section)
MedDRA version: 20.0 Level: LLT Classification code 10046721 Term: Urothelial carcinoma bladder stage III System Organ Class: 100000017505
MedDRA version: 20.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000015833
MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0 Level: LLT Classification code 10023400 Term: Kidney cancer System Organ Class: 100000056053

Intervention(s)

Product Name: Atezolizumab (MPDL3280A)
Product Code: RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ATEZOLIZUMAB
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
INN or Proposed INN: ATEZOLIZUMAB
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 125-

Trade Name: Docetaxel
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL
Other descriptive name: DOCETAXEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: Avastin
Product Name: Bevacizumab
Product Code: RO4876646
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Current Sponsor code: RO4876646
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: SUTENT
Product Name: Sunitinib
Product Code: RO4632993
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: SUNITINIB
CAS Number: 557795-19-4
Current Sponsor code: RO4632993
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 12.5-50

Trade Name: Javlor
Product Name: vinflunine
Product Code: RO7059926
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: VINFLUNINE
CAS Number: 162652-95-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Main Objective: To provide continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent-study closure

Secondary Objective: - To evaluate the safety of atezolizumab monotherapy or atezolizumab administered with combined agent(s) or comparator agent(s)
- To evaluate overall survival data with regard to administration of atezolizumab monotherapy or atezolizumab administered in combination with other agent(s) or comparator agent(s)

Primary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1-3. Throughout the study

Secondary end point(s): 1. Incidence and severity of serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0
2. Incidence and severity of adverse events of special interest, with severity determined according to NCI CTCAE, v4.0
3. Time to death due to any cause

Secondary ID(s)

BO39633

2016-005189-75-CZ

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd