AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer

AstraZeneca logo

AstraZeneca

Status and phase

Active, not recruiting
Phase 1

Conditions

Advanced Metastatic Breast Cancer

Treatments

Drug: AZD2014
Drug: Fulvestrant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01597388
264477 (Other Identifier)
D2270C00005
BRE-196

Details and patient eligibility

About

The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant

Full description

A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination with Intramuscular (IM) Fulvestrant to Patients with Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer.

Enrollment

99 patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis
  • Aged at least 18
  • 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
  • Histological or cytological confirmation of an ER+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients must have evidence of non-child-bearing potential.

Exclusion criteria

  • Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites)
  • Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study.
  • 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.
  • Patients with diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

99 participants in 1 patient group

AZD2014 with Fulvestrant
Experimental group
Description:
AZD2014 with Fulvestrant
Treatment:
Drug: Fulvestrant
Drug: AZD2014

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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