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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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


Inclusion Criteria:



- Written consent

- Cancer diagnosis & stage

- Patients for whom no standard therapy exists

- World Health Organization (WHO) performance status 0-2

- One or more measurable lesions

Exclusion Criteria:

- Prostate cancer

- Untreated unstable brain or meningeal metastases

- Specific laboratory ranges

- Pregnant or breast-feeding women

- Any evidence of severe or uncontrolled diseases

- Participation in other trials within 30 days

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

assessed at each visit

Safety Issue:

No

Principal Investigator

Jane Roberston

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

D8480C00014

NCT ID:

NCT00475956

Start Date:

May 2007

Completion Date:

October 2009

Related Keywords:

  • Neoplasms
  • Cancer
  • Tumour
  • Advanced Solid Tumour
  • Lung Cancer
  • Breast Cancer
  • Cholangiocarcinoma
  • Colon Cancer
  • Gastric Cancer
  • Choriocarcinoma
  • Liver Cancer
  • Myeloma
  • Ovarian Cancer
  • Pancreatic Cancer
  • Peritoneal Cancer
  • Neoplasms

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