Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis

Thank you

Trial Information

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


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

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 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

Outcome Time Frame:

various timepoints.

Safety Issue:

Yes

Principal Investigator

James Carmichael, BSc MBChB MD FRCP

Investigator Role:

Study Director

Investigator Affiliation:

KuDOS Pharmaceuticals Ltd

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D0810C00022

NCT ID:

NCT00710268

Start Date:

June 2008

Completion Date:

November 2009

Related Keywords:

  • Neoplasm Metastasis
  • Bevacizumab
  • Poly(ADP ribose) polymerases
  • Metastatic Solid Tumours
  • PARP inhibitor
  • Neoplasms
  • Neoplasm Metastasis

Name

Location