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A Phase I, Randomised, 2 Period Cross Over Study to Determine the Comparative Bioavailability of Two Different Oral Formulations of AZD2281 in Cancer Patients With Advanced Solid Tumours


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

A Phase I, Randomised, 2 Period Cross Over Study to Determine the Comparative Bioavailability of Two Different Oral Formulations of AZD2281 in Cancer Patients With Advanced Solid Tumours


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Jane Robertson, BSc, MBCHB, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D0810C00024

NCT ID:

NCT00777582

Start Date:

October 2008

Completion Date:

March 2014

Related Keywords:

  • Solid Tumors
  • Poly (ADP ribose) polymerases
  • Homologous Recombination Deficiency (HRD)
  • Advanced solid tumours
  • Neoplasms

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