NCT00750841

Brief Summary

Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body handles the experimental drug cediranib in patients with advanced cancer.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
8mo left

Started Sep 2008

Longer than P75 for phase_1

Geographic Reach
2 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Sep 2008Dec 2026

Study Start

First participant enrolled

September 9, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2009

Completed
17.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

September 10, 2008

Last Update Submit

February 19, 2026

Conditions

Solid Tumors

Keywords

advanced cancermetastaticrifampicinpharmacokineticsPhase IAdvanced solid tumours

Outcome Measures

Primary Outcomes (1)

  • To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin

    PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables.

Secondary Outcomes (1)

  • To assess the safety and tolerability of cediranib in the presence of rifampicin, by assessment of Adverse events (AEs) Laboratory findings, Vital signs, physical examination and Electrocardiogram.

    Until study drug is discountinued

Study Arms (1)

1

EXPERIMENTAL

Cediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone.

Drug: cediranib

Interventions

cediranibDRUG

45 mg cediranib once daily from Days 1-7; cediranib 45 mg plus 600 mg rifampicin from Days 8-14; 45 mg cediranib once daily from Days 15-28; from Day 29 patients may continue on 45 mg cediranib or dose reduce.

Also known as: RECENTIN
1

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
  • Estimated life expectancy of at least 8 weeks
  • WHO performance status (PS) 0-2.

You may not qualify if:

  • Unstable brain/meningeal metastases
  • Biochemistry/haematology results outside of required ranges
  • History of significant GI impairment
  • Inadequate bone marrow reserve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Research Site

Montreal, Quebec, H3T 1E2, Canada

Location

Research Site

Dundee, DD1 9SY, United Kingdom

Location

Research Site

Glasgow, G12 0YN, United Kingdom

Location

Research Site

London, NW1 2PG, United Kingdom

Location

Research Site

London, SE1 9RT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

cediranib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Sawyer, MD

    Cross Cancer Institute, Edmonton, AB, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

September 9, 2008

Primary Completion

July 30, 2009

Study Completion (Estimated)

December 31, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

CA(2)GB(4)