Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014

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AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Advanced Solid Malignancies

Treatments

Drug: AZD2014

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026402
2009-015244-42 (EudraCT Number)
D2270C00001

Details and patient eligibility

About

The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug. The study will also assess the blood levels and action of AZD2014 in the body over a period of time and will indicate whether the drug has an effect on the types of cancer the patients have.

Enrollment

172 patients

Sex

All

Ages

18 to 150 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histological or cytological confirmation of a solid, malignant tumour that is refractory to standard therapies or for which no standard therapies exist
  • At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
  • World Health Organisation performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks

Exclusion criteria

  • Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks prior to first dose of study drug
  • Patients with abnormal fasting glucose, type I or uncontrolled type II diabetes
  • Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

172 participants in 1 patient group

AZD2014
Experimental group
Description:
AZD2014 dose escalation phase in Part A and expansion phase in Part B.
Treatment:
Drug: AZD2014

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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