Back to resultsGlobal Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
Primary Purpose
Advanced Solid Malignancies, Malignant Lymphoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AZD1208
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Malignancies focused on measuring Advanced solid malignancies, Malignant lymphoma
Eligibility Criteria
Inclusion Criteria:
- Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
- Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
- Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
- Patients who have at least one lesion that can be accurately assessed
Exclusion Criteria:
- Patients who have recently received or are receiving prohibited medications or treatments
- Patients who have any unresolved side effects of previous treatments
- Patients who have spinal cord compression or brain metastases
- Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus [HIV] infection)
- Patients with significant abnormal ECG findings
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
AZD1208
Arm Description
Outcomes
Primary Outcome Measures
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01588548
Brief Title
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
Official Title
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients With Advanced Solid Malignancies Including Malignant Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma
Detailed Description
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Malignancies, Malignant Lymphoma
Keywords
Advanced solid malignancies, Malignant lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD1208
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AZD1208
Intervention Description
Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose
Primary Outcome Measure Information:
Title
Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.
Time Frame
Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
Patients who have at least one lesion that can be accurately assessed
Exclusion Criteria:
Patients who have recently received or are receiving prohibited medications or treatments
Patients who have any unresolved side effects of previous treatments
Patients who have spinal cord compression or brain metastases
Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus [HIV] infection)
Patients with significant abnormal ECG findings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Neumann, MSD
Organizational Affiliation
AZ
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Chuo-ku
Country
Japan
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Surrey
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=457&filename=CSR_Synopsis_D4510C00005.pdf
Description
CSR_Synopsis_D4510C00005.pdf
Learn more about this trial
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
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