Active — Not RecruitingPhase 1

Phase I Comparative Bioavailability Study

Australia, Belgium, Switzerland197 participantsStarted 2008-10-27

Plain-language 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

Who can participate

Age range18 Years – 130 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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.

Timeframe: at every visit

Trial details

NCT IDNCT00777582

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-02-06

View on ClinicalTrials.gov More Solid Tumors trials

Who can participate

Age range18 Years – 130 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation

Timeframe: Blood samples (12) will be taken at pre-defined intervals following dosing of a single capsule and a single tablet dose

Timeframe: 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

Timeframe: at every visit