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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01588548
First received: April 27, 2012
Last updated: October 6, 2015
Last verified: October 2015
  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: Allocation: Non-Randomized
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:
  • Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) [ 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 43
Study Start Date: July 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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 to 130 Years   (Adult, Senior)
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

Locations
Japan
Research Site
Chuo-ku, Japan
United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Surrey, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Frank Neumann, MSD AZ
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01588548     History of Changes
Other Study ID Numbers: D4510C00005 
Study First Received: April 27, 2012
Results First Received: July 24, 2015
Last Updated: October 6, 2015
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:
Lymphoma
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 23, 2016