Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients

A Phase I Open Label, Multi Centre Study of AZD2281 Administered Orally in Combination With Cisplatin, to Assess the Safety and Tolerability in Patients With Advanced Solid Tumours

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00782574

Enrollment

Registered

2008-10-31

Start date

2008-11-12

Completion date

2023-12-07

Last updated

2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

Advanced solid tumours, Poly(ADP ribose) polymerases, homologous deficiency, BRCA1

Brief summary

A Phase I study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled

Interventions

DRUGAZD2281

Tablets Oral BID

DRUGCisplatin

IV every 3 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Life expectancy of at least 12 weeks * Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent * Patients with measurable or non measurable disease according to RECIST

Exclusion criteria

* Less than 28 days from active therapy (ie any treatment used to treat the disease) or high dose radiotherapy * Brain Metastases or spinal cord compression unless irradiated at least 4 weeks before entry and stable without steroid treatment for \>1 week * Persistent CTCAE Grade 2 or greater toxicities (excluding alopecia) caused by prior therapy

Design outcomes

Primary

Measure	Time frame
To determine the safety and tolerability of AZD2281 in combination with Cisplatin (eg Adverse Events, Pharmacokinetic for AZD2281, overall response rate) to patients with advanced solid tumours.	Weekly visits for routine monitoring visits

Secondary

Measure	Time frame
To make a preliminary assessment of the anti-tumour activity of AZD2281 when given in combination with Cisplatin, by measuring overall objective response rate.	Assessed at screening, visit 9, and at end of every 2 cycles
To compare exposure to AZD2281 when given alone and in combination with Cisplatin (Only in patients receiving continuous dosing of AZD2281).	PK samples taken at visit 2 and 3

Countries

Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026