Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00475956

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

13.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: AZD2171 Drug: AZD0530	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 AZD2171 Monotherapy	Drug: AZD2171 oral tablet multiple ascending doses 20, 30 or 45 mg Other Names: cediranib RECENTIN™
Experimental: 2 AZD2171 + AZD0530	Drug: AZD2171 oral tablet multiple ascending doses 20, 30 or 45 mg Other Names: cediranib RECENTIN™ Drug: AZD0530 oral tablet multiple ascending doses 125 mg or 175 mg

Arm

Intervention/Treatment

Experimental: 1

AZD2171 Monotherapy

Drug: AZD2171

oral tablet multiple ascending doses 20, 30 or 45 mg

Other Names:

cediranib

RECENTIN™

Experimental: 2

AZD2171 + AZD0530

Drug: AZD2171

oral tablet multiple ascending doses 20, 30 or 45 mg

Other Names:

cediranib

RECENTIN™

Drug: AZD0530

oral tablet multiple ascending doses 125 mg or 175 mg

Outcome Measures

Primary Outcome Measures

Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam [assessed at each visit]

Secondary Outcome Measures

Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530 [assessed at each visit]
Safety and efficacy [assessed at each visit]
Genetic variation of pathways targeted by AZD2171 and AZD0530 [assessed during study]