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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Malignancies, Malignant Lymphoma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.]

Outcome Time Frame:

first 21 day cycle of once daily dosing

Safety Issue:

Yes

Principal Investigator

Joseph P Eder, MD

Investigator Role:

Study Director

Investigator Affiliation:

AZ

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

D4510C00005

NCT ID:

NCT01588548

Start Date:

July 2012

Completion Date:

December 2013

Related Keywords:

  • Advanced Solid Malignancies
  • Malignant Lymphoma
  • Advanced solid malignancies
  • Malignant lymphoma
  • Neoplasms
  • Lymphoma

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