- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02004106
A Study to Evaluate Safety, Pharmacokinetics, and Efficacy of RO6895882 in Participants With Advanced and/or Metastatic Solid Tumors
March 2, 2018 updated by: Hoffmann-La Roche
An Open-Label, Multi-Center, Dose-Escalation, Phase I Study With an Expansion Phase, to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6895882, an Immunocytokine, Consisting of a Variant of Interleukin-2 (IL-2v) Targeting Carcinoembryonic Antigen (CEA) Administered Intravenously, in Patients With Advanced and/or Metastatic Solid Tumors
This open-label, multi-center, dose-escalation study will evaluate the safety, pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy.
The study will be conducted in 3 parts.
Part 1 will be a single ascending dose study in single participant cohort at low RO6895882 dose (less than or equal to [</=] 6 milligrams [mg]).
Part 2 will be a dose-escalation study of RO6895882 monotherapy given every week (qw), every 2 weeks (q2w), and possibly every 3 weeks (q3w).
Part 3 will be an expansion phase of the qw, q2w, and possibly q3w at maximum tolerated dose (MTD) (as determined in Part 2).
Part 3 will only be conducted if the risk/benefit assessment, as evaluated by the Sponsor and the investigators, is in favor of the participants.
Participants will be treated until disease progression, unacceptable toxicity or withdrawal from treatment for other reasons or death for a maximum duration of 24 months.
Study Overview
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
København Ø, Denmark, 2100
- Rigshospitalet, Onkologisk Klinik
-
-
-
-
-
Helsinki, Finland, 00029
- Helsinki University Central Hospital; Dept of Oncology
-
-
-
-
-
Villejuif, France, 94805
- Institut Gustave Roussy; Departement Oncologie Medicale
-
-
-
-
-
Amsterdam, Netherlands, 1066 CX
- Antoni van Leeuwenhoek Ziekenhuis
-
Amsterdam, Netherlands, 1081 HV
- VU MEDISCH CENTRUM; Dept. of Medical Oncology
-
-
-
-
-
Barcelona, Spain, 08035
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
-
-
Navarra
-
Pamplona, Navarra, Spain, 31008
- Clinica Universitaria de Navarra; Servicio de Oncologia
-
-
-
-
-
Lausanne, Switzerland, 1011
- CHUV; Departement d'Oncologie
-
-
-
-
-
Oxford, United Kingdom, OX3 7LE
- Oxford University Hospitals NHS Trust - Churchill Hospital
-
-
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants with confirmed advanced and/or metastatic solid tumor, with at least one tumor lesion of non-critical location accessible to biopsy who have progressed on the standard of care therapy
- Locally confirmed CEA expression in tumor tissue (more than [>] 20 percent (%) of tumor cells staining with at least moderate intensity) or centrally confirmed CEA expression if no archival tumor tissue and fresh biopsy is collected
- Radiologically measurable and clinically evaluable disease
- Life expectancy of greater than or equal to (>/=) 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- All acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedure must have resolved to Grade </=1, except alopecia (any grade) and Grade 2 peripheral neuropathy
- Adequate hematological, liver, and renal function
- Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women </=2 years after menopause
- Participants with Gilbert's syndrome will be eligible for the study. A diagnosis of Gilbert's syndrome will be based on the exclusion of other diseases based on the following criteria: (i) unconjugated hyperbilirubinemia noted on several occasions; (ii) no evidence of hemolysis (normal hemoglobin, reticulocyte count, and Lactate dehydrogenase); (iii) normal liver function tests; (iv) absence of other diseases associated with unconjugated hyperbilirubinemia
Exclusion Criteria:
- History or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before screening
- Participants with an active second malignancy (other than non-melanoma skin cancer, or cervical carcinoma in situ). Participants who have a history of malignancy are not considered to have an active malignancy if they have completed therapy and are considered by their treating physician to be at less than (<) 30% risk for relapse
- Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
- Uncontrolled hypertension (systolic >150 millimeter of mercury [mmHg] and/or diastolic >100 mmHg), unstable angina, congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment
- Active or uncontrolled infections
- Known infection with human immunodeficiency virus (HIV), seropositive status
- Positive test results for chronic hepatitis B infection (defined as positive Hepatitis B surface antigen [HBsAg] serology and/or HBcAb status)
- Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- Pregnant or breast-feeding women
- Known hypersensitivity to any of the components of RO6895882
- Concurrent therapy with any other investigational drug
- Regular immunosuppressive therapy (that is, for organ transplantation, chronic rheumatologic disease)
- Chronic use of steroids (including inhaled) will not be allowed. Concurrent high doses of systemic corticosteroids. High dose is considered as >20 mg of dexamethasone a day (or equivalent) for >7 consecutive days
- Radiotherapy within the last 4 weeks before start of study drug treatment with the exception of limited field palliative radiotherapy for bone pain relief
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: RO6895882 Single Ascending Dose
Participants will receive RO6895882 at ascending doses (</= 6 mg) as a single intravenous (IV) infusion.
|
Participants will receive RO6895882 at different dose levels and schedules defined in respective arms as IV infusion.
|
Experimental: Part 2: RO6895882 Dose Escalation Monotherapy
Participants in different cohorts will receive RO6895882 at ascending doses as IV infusion qw, q2w or q3w.
After completion of Part 2 all participants have the option to receive the recommended RO6895882 dose once defined in Part 2 at the discretion of investigator.
|
Participants will receive RO6895882 at different dose levels and schedules defined in respective arms as IV infusion.
|
Experimental: Part 3: RO6895882 MTD Expansion
Participants will receive RO6895882 at MTD determined in Part 2 as IV infusion qw, q2w or q3w.
|
Participants will receive RO6895882 at different dose levels and schedules defined in respective arms as IV infusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 2: Percentage of Participants With Dose-Limiting Toxicity (DLT)
Time Frame: Part 2: within 21 days after the highest dose administration
|
Part 2: within 21 days after the highest dose administration
|
|
Part 2: MTD of RO6895882
Time Frame: Part 2: within 21 days after the highest dose administration
|
Part 2: within 21 days after the highest dose administration
|
|
Percentage of Participants With Adverse Events
Time Frame: Day 1 up to 28 days after last dose of study drug (up to approximately 25 months)
|
Day 1 up to 28 days after last dose of study drug (up to approximately 25 months)
|
|
Percentage of Participants With Anti-drug Antibodies (ADAs) Against RO6895882
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hour [Hr] 0).
Part 2/3: qw schedule (1 cycle = 1 week): Predose in Cycle 1, 4, 5, 6, thereafter every 2 months; Part 2/3: q2w schedule (1 cycle = 2 weeks): Predose in Cycle 1, 4, 6, thereafter every 8 weeks.
Part 2/3: q3w schedule (1 cycle = 3 weeks): Predose in Cycle 1, 2, 3, 4, 6, thereafter every 9 weeks.
Additionally at treatment discontinuation or at 28-days after last dose (up to approximately 25 months)
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Area Under the Serum Concentration-Time Curve (AUC) of RO6895882
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Predose (Hr 0), 1 hr post start of infusion (SoI), at end of infusion (EoI), 2, 4, 24, 72, 96, 216 hrs post Day 1 dose.
Part 2/3: qw schedule (1 cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle.
Part 2/3: q2w schedule (1 cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles.
Part 2/3: q3w schedule (1 cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles.
Maximum infusion length = 2 hrs.
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Minimum Observed Serum Concentration (Cmin) of RO6895882
Time Frame: Part 1/2/3: Predose (Hr 0) in all cycles (maximum up to 25 months) (cycle length = 1, 2, or 3 weeks, respectively)
|
Part 1/2/3: Predose (Hr 0) in all cycles (maximum up to 25 months) (cycle length = 1, 2, or 3 weeks, respectively)
|
|
Maximum Observed Serum Concentration (Cmax) of RO6895882
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose.
Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle.
Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles.
Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles.
Maximum infusion length = 2 hrs.
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Clearance (CL) of RO6895882
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose.
Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle.
Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles.
Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles.
Maximum infusion length = 2 hrs.
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Volume of Distribution at Steady State (Vss) of RO6895882
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose.
Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle.
Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles.
Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles.
Maximum infusion length = 2 hrs.
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Half-life (t1/2) of RO6895882
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose.
Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle.
Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles.
Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles.
Maximum infusion length = 2 hrs.
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count of Cluster of Differentiation (CD) 4+ Cells Analyzed by Flow Cytometry
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose.
Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI.
Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs.
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Count of CD8+ Cells Analyzed by Flow Cytometry
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose.
Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI.
Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs.
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Count of B Lymphocyte Cells Analyzed by Flow Cytometry
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose.
Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI.
Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Count of Natural Killer (NK) Cells Analyzed by Flow Cytometry
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose.
Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI.
Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Count of Monocytes Cells Analyzed by Flow Cytometry
Time Frame: Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Part 1: Predose (Hr 0), at EoI, Day (D) 2. Part 2/3: qw schedule (1 cycle = 1 week): Cycle (C) 1: Predose, at EoI, D2, D5; C2: Predose, at EoI, D2; C3: Predose, at EoI; C4: Predose.
Part 2/3: q2w schedule (1 cycle = 2 weeks): C1, C4: Predose, at EoI, D2, D5, C2: Predose, at EoI, D2; C3: Predose, at EoI.
Part 2/3: q3w schedule (1 cycle = 3 weeks): C1: Predose, at EoI, Day 2, 5, 14; C3: Predose, at EoI, Day 2, 5; C2, C4: Predose, at EoI, Day 2. Maximum infusion length = 2 hrs.
|
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
|
Percentage of Participants With Objective Response Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
Time Frame: From Screening until disease progression or death (up to approximately 25 months)
|
From Screening until disease progression or death (up to approximately 25 months)
|
|
Percentage of Participants With Stable Disease Assessed According to RECIST v 1.1
Time Frame: From Screening until disease progression or death (up to approximately 25 months)
|
From Screening until disease progression or death (up to approximately 25 months)
|
|
Percentage of Participants With Disease Control Assessed According to RECIST v 1.1
Time Frame: From Screening until disease progression or death (up to approximately 25 months)
|
From Screening until disease progression or death (up to approximately 25 months)
|
|
Progression-Free Survival Assessed According to RECIST v 1.1
Time Frame: From Screening until disease progression or death (up to approximately 25 months)
|
From Screening until disease progression or death (up to approximately 25 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 31, 2013
Primary Completion (Actual)
August 31, 2016
Study Completion (Actual)
August 31, 2016
Study Registration Dates
First Submitted
December 3, 2013
First Submitted That Met QC Criteria
December 3, 2013
First Posted (Estimate)
December 6, 2013
Study Record Updates
Last Update Posted (Actual)
March 6, 2018
Last Update Submitted That Met QC Criteria
March 2, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- BP28920
- 2013-003041-41 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms
-
John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedUterine Cervical Neoplasms | Prostatic Neoplasms | Rectal Neoplasms | Endometrial Neoplasms | Anus NeoplasmsUnited States
-
GlaxoSmithKlineRecruitingColonic Neoplasms | Neoplasms, ColonUnited States, Finland, France, Italy, Japan, Netherlands, Norway, Spain, Taiwan, United Kingdom, Australia, Belgium, Brazil, Germany, Greece, Sweden, Turkey, Canada, Korea, Republic of, Argentina, Hungary, Estonia, Portugal, Mexico, Pa...
-
University Health Network, TorontoPrincess Margaret Hospital, CanadaCompletedUterine Neoplasms | Prostatic Neoplasms | Cervix Neoplasms | Bladder NeoplasmsCanada
-
N.N. Petrov National Medical Research Center of...Active, not recruitingColonic Neoplasms MalignantRussian Federation
-
Peking University First HospitalShengli Oilfield Hospital; The Second Affiliated Hospital of Baotou Medical...Enrolling by invitationRectal Neoplasms MalignantChina
-
Cancer Institute and Hospital, Chinese Academy...CompletedRectal Neoplasms MalignantChina
-
Seattle Children's HospitalSuspendedNeoplasms, Benign | Neoplasms, MalignantUnited States
-
Iuliu Hatieganu University of Medicine and PharmacyInstitutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian...CompletedRetroperitoneal NeoplasmsRomania
-
Pennington Biomedical Research CenterNational Cancer Institute (NCI)RecruitingRectal Neoplasms | Colonic NeoplasmsUnited States
-
Cancer Institute and Hospital, Chinese Academy...Not yet recruitingRadiotherapy | Rectal Neoplasms MalignantChina
Clinical Trials on RO6895882
-
Hoffmann-La RocheCompletedSolid TumorsUnited States, Denmark, Spain, Switzerland, Netherlands, Canada