Clinical Trials Logo
  1. Home
  2. Advanced Cancer
  3. NCT00621725
  4. Details
NCT00621725 Clinical Trial

Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours

Advanced Cancer Clinical Trial

Official title:
A Phase I, Open Label Study of the Pharmacokinetics and Safety of Cediranib (RECENTINTM, AZD2171) Following Single and Multiple Oral Doses in Patients With Advanced Solid Tumours With Various Degrees of Hepatic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00621725
Other study ID # D8480C00032
Secondary ID EUDRACT number 2
Status Completed
Phase Phase 1
First received February 13, 2008
Last updated July 14, 2014
Start date January 2008
Est. completion date January 2014

Study information
Verified date July 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

To determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise Cediranib.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date January 2014
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written informed consent

- Advanced solid tumour (not prostate cancer) for which no standard therapy exists

- WHO performance status 0-2

- Bilirubin levels within the target range

Exclusion Criteria:

- Unstable brain/meningeal metastases

- Inadequate bone marrow reserve

- Biochemistry/haematology results outside of required ranges

- History of significant GI impairment

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• AZD2171
Oral dose

Locations
Country Name City State
Denmark Research Site København Ø
Netherlands Research Site Nijmegen
Netherlands Research Site Rotterdam

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels). Single dose PK assessed on Day 1 of dosing No
Secondary Safety/tolerability of Cediranib (single and multiple dose PK) Single and multiple dose PK assessed on Day 1 of the single dosing period and Day 21 of the multiple dosing period, respectively (minimum 7 day washout following single dosing) assessed from randomisation to data cut-off (15th July 2010) No
See also
  Status Clinical Trial Phase
Completed NCT03181854 - Randomized Controlled Trial of Integrated Early Palliative Care N/A
Completed NCT01197170 - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Phase 1
Recruiting NCT05045040 - Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03994601 - An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Completed NCT01393990 - A Study of LY2228820 in Participants With Advanced Cancer Phase 1
Completed NCT02857270 - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Active, not recruiting NCT04121676 - Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer Phase 1
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2
Active, not recruiting NCT03674567 - Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab Phase 1/Phase 2
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A
Completed NCT02778126 - A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer Phase 1
Completed NCT02507544 - A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer Phase 1
Completed NCT02529553 - A Study of LY3076226 in Participants With Advanced or Metastatic Cancer Phase 1
Completed NCT02245204 - Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers Phase 1
Completed NCT01901237 - Yoga for Adolescent and Young Adult Non-Curative Cancer Patients N/A
Terminated NCT01929941 - An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies Phase 1

External Links