Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01588548
First received: April 27, 2012
Last updated: August 8, 2012
Last verified: August 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014