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

Neoplasm Metastasis Clinical Trial

Official title:

A Phase I, Open Label, Dual Centre Study To Assess The Safety And Tolerability Of AZD2281 In Combination With Bevacizumab (Avastin®) In Patients With Advanced Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710268
• Other study ID #: D0810C00022
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2008
• Last updated: January 13, 2015
• Start date: June 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent

• Adequate bone marrow, kidney and liver function in accordance with laboratory parameters set out in the protocol

• Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

• Disorders that may put the patient at risk of bleeding, including gastrointestinal perforation, intra-abdominal abcess, major surgery of the chest or abdomen, previous haemorrhage, coughing up blood or thrombotic event

• Hypertension (high blood pressure) or significant cardiovascular disease

• Hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanised antibodies

Study Design

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

Related Conditions & MeSH terms

• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		various timepoints.	Yes
Secondary	To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters		various timepoints.	No

External Links

•   D0810C00022_CSR_Synopsis