Study to Assess Safety & Tolerability of AZD2281 in Combination With Bevacizumab in Patients With Advanced Solid Tumours

Sponsor
AstraZeneca
Study ID
NCT00710268
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasm Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD2281 — DRUG
    Oral Capsule, Dose Escalation 50, 100, 200, 400 mgContinuous twice daily dosing
  • Bevacizumab — DRUG
    IV administration10 mg/kg every 14 days

Study Details

Phase I, open label, dual centre, dose finding study to evaluate the safety and tolerability of continuous twice daily oral dosing with AZD2281 when administered in combination with Bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.

Key Dates

First listed
Jul 4, 2008
Start date
Jun 30, 2008
Status verified
Jan 2015
Primary completion
Mar 31, 2009
Completion
Nov 30, 2009

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Dose Escalation Study 50, 100, 200, 400 mg

Primary Outcome Measure

safety and tolerability of twice daily oral doses of AZD2281 when administered in combination with Bevacizumab to patients with advanced solid tumours by assessment of adverse events, vital signs, ECG, clinical chem, haematology, urinalysis and phys exam [ Time Frame: various timepoints. ]

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