NCT00731263

Brief Summary

The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2008

Typical duration for phase_1

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

August 6, 2008

Last Update Submit

July 10, 2012

Conditions

Solid Tumors

Keywords

CancerAdvance solid tumoursDose EscalationPreliminary efficacyAZD8055Tor kinase inhibitorOral administration

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of AZD8055

    Assessed at all visits

Secondary Outcomes (2)

  • To identify early signals of anti-tumour activity

    Visits 1, 5, and 9 and 11

  • To identify early signals of anti-tumor activity

    Visits 1, 5, 9 and 13

Study Arms (1)

1

EXPERIMENTAL

The study will start with AZD8055 formulated in a liquid solution prior to the tablet formulation becoming available. The tablet formulation will be introduced in Part A at the beginning of a new cohort at an appropriate dose, no higher than the dose of the liquid formulation in the last completed evaluated cohort. Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment.

Drug: AZD8055

Interventions

AZD8055DRUG

Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

New York, New York, 10065, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Clichy, France

Location

Research Site

Sutton, Surrey, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

(5-(2,4-bis((3S)-3-methylmorpholin-4-yl)pyrido(2,3-d)pyrimidin-7-yl)-2-methoxyphenyl)methanol

Study Officials

  • Prof Stan Kaye

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

    PRINCIPAL INVESTIGATOR

  • Dr Carol Aghajanian

    Memorial Sloan-Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065, USA

    PRINCIPAL INVESTIGATOR

  • Dr Aung Naing

    MD Anderson Cancer Centre, 1515 Holcombe Blvd, Houston, Texas, USA

    PRINCIPAL INVESTIGATOR

  • Professor Eric Raymond

    Hôpital Beaujon, 100, Boulevard du Général Leclerc, 92118 Clichy Cedex, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 8, 2008

Study Start

July 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

FR(1)GB(1)US(2)