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A Phase I, Open-label Study to Assess the Safety and Tolerability of AZD0530 in Combination With Carboplatin and/or Paclitaxel Chemotherapy in Patients With Solid Tumours


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Phase I, Open-label Study to Assess the Safety and Tolerability of AZD0530 in Combination With Carboplatin and/or Paclitaxel Chemotherapy in Patients With Solid Tumours


Inclusion Criteria:



- Life expectancy > 12 weeks

- Women defined as post-menopausal

- Male or female patients with locally advanced or metastatic cancer suitable for
treatment with carboplatin and/or paclitaxel

Exclusion Criteria:

- Inadequate bone marrow reserve

- Inadequate live function, renal function or low haemoglobin

- Unresolved toxicity from anti-cancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans.

Outcome Time Frame:

Assessed at each visit

Safety Issue:

No

Principal Investigator

Steinar Aamdal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radium Hospital, Norway

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D8180C00023

NCT ID:

NCT00496028

Start Date:

March 2007

Completion Date:

March 2010

Related Keywords:

  • Neoplasms
  • Solid tumors
  • locally advanced or Metastatic Cancer suitable for treatment with carboplatin and/or paclitaxel
  • Neoplasms

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