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Clinical Trials in Switzerland / NCT00777582
Active, not recruiting Phase 1

Phase I Comparative Bioavailability Study

NCT00777582 · tracked via the Priya Life Science Switzerland tracker
Sponsor
AstraZeneca
Phase
Phase 1
Started
2008-10-27
Last updated
2026-08-06

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

AZD2281 →

AZD2281: Oral single dose formulation

Study summary

The purpose of this phase I randomised cross over study is to determine and compare the bioavailability of two different oral formulations of AZD2281 in advanced solid tumour cancer patients

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed malignant advanced solid tumour, which is refractory to standard therapies (except Group 8 patients who must not be platinum refractory) or for which no suitable effective standard therapy exists * Patients must have adequate organ and bone marrow function measured within 7 days prior to administration of study treatment * Female patients must have evidence of non-child bearing status: negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing, or postmenopausal status Exclusion Criteria: * Patients receiving chemotherapy, radiotherapy (except for palliative reasons) or any other anti-cancer therapy within 4 weeks of the last dose prior to study entry. Patients may continue the use of biphosphonates for bone metastases and corticosteroids * Patients with symptomatic uncontrolled brain metastases * Major surgery within 2 weeks of starting study and patients must have recovered from any effects of any major surgery * Patients who are platinum refractory (Group 8 only) * Patients with myelodysplastic syndrome/acute myeloid leukaemia (Group 8 only).

Primary outcome measure(s)

  • PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation — Blood samples (12) will be taken at pre-defined intervals following dosing of a single capsule and a single tablet dose
  • Continued Supply Phase: To enable patients to continue to receive treatment with AZD2281. Safety and tolerability data will be collected to further determine the safety and tolerability of the capsule formulation of AZD2281 in these patients — every 28 days
  • Continued Supply Expansion Phase: To compare the safety and tolerability of the tablet and capsule formulation of AZD2281 in all patients: Safety, AEs, Physical Exam, vital signs — at every visit
  • Dose Escalation Phase of continued supply expansion: To determine safety & tolerability of higher than 200mg bid (to 400mg) of tablet & compare safety & tolerability profile of tablet with 400mg capsule — at every visit
  • Randomised tablet formulation continued supply expansion phase (Group 8): To determine the safety and tolerability profile of selected tablet dose schedules of the melt-extrusion (tablet) formulation. — at every visit

Trial sites (10)

FacilityCityRegionStatus
Research Site Randwick Australia
Research Site Leuven Belgium
Research Site Bellinzona Switzerland
Research Site Edinburgh United Kingdom
Research Site London United Kingdom
Research Site Manchester United Kingdom
Research Site Newcastle upon Tyne United Kingdom
Research Site Northwood United Kingdom
Research Site Oxford United Kingdom
Research Site Sutton United Kingdom

More AstraZeneca trials in Switzerland

A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer Recruiting
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) Active, not recruiting
DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer Recruiting
PASS of Paediatric Patients Initiating Selumetinib Active, not recruiting
Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Recruiting

Other trials for the same condition

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma Recruiting
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) Recruiting
Study of INCB123667 in Subjects With Advanced Solid Tumors Active, not recruiting
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Active, not recruiting
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00777582 on ClinicalTrials.gov ↗ ← All trials in Switzerland