Know Cancer

or
forgot password

A Phase I, Open Label, Multicenter Study to Assess the Safety, Tolerability and Pharmacology of AZD2281 in Combination With Liposomal Doxorubicin (Caelyx®) in Patients With Advanced Solid Tumors


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

Thank you

Trial Information

A Phase I, Open Label, Multicenter Study to Assess the Safety, Tolerability and Pharmacology of AZD2281 in Combination With Liposomal Doxorubicin (Caelyx®) in Patients With Advanced Solid Tumors


Inclusion Criteria:



- Histologically or cytologically confirmed metastatic cancer, not amenable to surgery
or radiation therapy with curative intent

- Measurable or evaluable disease

- ECOG Performance status 0 - 2

- Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

- More than 3 prior lines of chemotherapy for advanced disease

- Less than 28 days from active treatment (ie, any treatment used to treat the disease)
or high dose radiotherapy (patients may continue concomitant use of stable dose of
bisphosphonates if used at least 28 days prior to commencing study treatment and pat

- Prior treatment with >300mg/m2 cumulative dose of doxorubicin equivalent

- Resistance to anthracyclines defined as progressive disease during anthracycline
treatment or within 6 months after the last anthracycline administration.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

recommended dose

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Jane Robertson, BSc, MBCHB, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

D0810L00001

NCT ID:

NCT00819221

Start Date:

January 2009

Completion Date:

August 2013

Related Keywords:

  • Solid Tumors
  • advanced tumors
  • solid tumors
  • dose escalation
  • combination
  • AZD2281
  • liposomal doxorubicin
  • pharmacology
  • phase I
  • multicenter
  • Neoplasms

Name

Location