Phase I Comparative Bioavailability Study

AstraZeneca

Status and phase: Active, not recruiting; Phase 1

Conditions: Solid Tumors

Treatments: Drug: AZD2281

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777582

2008-003697-18 (EudraCT Number)

D0810C00024

Details and patient eligibility

About

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

Enrollment: 197 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

197 participants in 3 patient groups

Treatment A

Experimental group

Description:

300mg bid (twice daily) tablet dose

Treatment:

Drug: AZD2281

Treatment B

Experimental group

Description:

400 mg twice daily (bid) capsule dose

Treatment:

Drug: AZD2281

Treatment C

Experimental group

Description:

400mg bid (twice daily) tablet dose

Treatment:

Drug: AZD2281