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Completed

NCT Number: NCT00475956

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

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.

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Key information

Conditions

Neoplasms Adenocarcinoma Adnexal Diseases Breast Diseases Breast Neoplasms Carcinoma Cholangiocarcinoma Choriocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Plasma Cell Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pregnancy Complications Pregnancy Complications, Neoplastic Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Trophoblastic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2171

Drug

oral tablet multiple ascending doses 20, 30 or 45 mg

Other names: cediranib, RECENTIN™

AZD0530

Drug

oral tablet multiple ascending doses 125 mg or 175 mg

Primary outcomes

  1. 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

    Time frame: assessed at each visit

Secondary outcomes

  1. Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530

    Time frame: assessed at each visit

  2. Safety and efficacy

    Time frame: assessed at each visit

  3. Genetic variation of pathways targeted by AZD2171 and AZD0530

    Time frame: assessed during study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
May 21, 2007
Registry last updated
Apr 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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