Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
This study is currently recruiting participants.
Verified August 2012 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01588548
First received: April 27, 2012
Last updated: August 8, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Malignancies Malignant Lymphoma |
Drug: AZD1208 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Part A: Number of patients with dose limiting toxicities (DLTs) [Maximum Tolerated Dose (MTD) is defined as the maximum dose level below the dose level at which 2 patients of a cohort (3 to 6 patients) experience DLTs during cycle 1.] [ Time Frame: first 21 day cycle of once daily dosing ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Single and multiple dose part: Description of the pharmacokinetics (PK) of AZD1208 in terms of maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the plasma concentration-time curve from zero to infinity (AUC) [ Time Frame: Cycle 0 Day 1- pre-dose through 24 hours post dose, 48 and 72 hours post dose. Pre-dose on Cycle 1 Day2. Cycle 1 Day 8 - pre-dose and 2-6 hours post dose. Cycle 1 Day 15 - pre-dose through 24 hours post-dose. ] [ Designated as safety issue: No ]Interval timepoints : predose, 15, mins, 30 m
- Single and multiple dose part: Description of the urine Pharmacokinetics(PK) of AZD1208 in terms of renal clearance (CLR) and amount of drug excreted unchanged (Ae; % dose). [ Time Frame: Cycle 0 Day 1- pre-dose through 24 hours post dose, 24-48 hours and 48-72 hours post dose. Cycle 1 Day 15 - pre-dose through 24 hours post-dose. ] [ Designated as safety issue: No ]
- Part A and B: Objective response rate defined as the percentage of patients who have at least one visit response of CR or PR prior to any evidence of progression (as defined by RECIST 1.1) [ Time Frame: Baseline, Cycle 1 Day 1, every 6 weeks up to 12 weeks and then every 12 weeks until discontinuation of study treatment or withdrawal of consent ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: AZD1208 |
Drug: AZD1208
Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588548
Contacts
| Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
Locations
| Japan | |
| Research Site | Recruiting |
| Tokyo, Japan | |
| United Kingdom | |
| Research Site | Not yet recruiting |
| Manchester, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Joseph P Eder, MD | AZ |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01588548 History of Changes |
| Other Study ID Numbers: | D4510C00005 |
| Study First Received: | April 27, 2012 |
| Last Updated: | August 8, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Advanced solid malignancies Malignant lymphoma |
Additional relevant MeSH terms:
|
Neoplasms Lymphoma Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013