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A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients With Advanced Solid Tumours.


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients With Advanced Solid Tumours.


Inclusion Criteria:



- Histological or cytological confirmation of an advanced solid malignant tumour (or
lymphoma Part A only)

- Cancer which is refractory to standard therapies or for which no standard therapy
exists, patients with measurable or non-measurable disease (according to RECIST
criteria) can be recruited to Part A

- Evidence of post-menopausal status or negative urine/serum pregnancy test for
pre-menopausal female patients

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 from first dose of study drug.

- Patients with abnormal fasting glucose, have type I or II Diabetes or have
uncontrolled blood fats and cholesterol

- Patients with a history of neurological disease, peripheral or central neuropathy,
brain metastases or family history of myopathy are excluded

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability of AZD8055

Outcome Time Frame:

Assessed at all visits

Safety Issue:

Yes

Principal Investigator

Prof Stan Kaye

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden Hospital, Sutton, Surrey, England, SM2 5PT

Authority:

United States: Food and Drug Administration

Study ID:

D1600C00001

NCT ID:

NCT00731263

Start Date:

July 2008

Completion Date:

November 2010

Related Keywords:

  • Solid Tumors
  • Cancer
  • Advance solid tumours
  • Dose Escalation
  • Preliminary efficacy
  • AZD8055
  • Tor kinase inhibitor
  • Oral administration
  • Neoplasms

Name

Location

Research SiteAlbany, New York  
Research SiteAbilene, Texas