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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Advanced Solid Malignancies Malignant Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZD1208

Group Type ACTIVE_COMPARATOR

AZD1208

Intervention Type DRUG

Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose

Interventions

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AZD1208

Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No