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
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors
Both
Advanced Solid Tumors
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
Weekly visits for routine monitoring visits
Safety Issue:
Yes
Principal Investigator
Jane Robertson, BSc, MBCHB, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Spain: Ministry of Health
Study ID:
D0810C00021
NCT ID:
NCT00782574
Start Date:
November 2008
Completion Date:
December 2013
Related Keywords:
- Advanced Solid Tumors
- Advanced solid tumours
- Poly(ADP ribose) polymerases
- homologous deficiency
- BRCA1
- Neoplasms
Name | Location |
|---|---|
| Research Site | Beverly, Massachusetts |
