Know Cancer

or
forgot password

An Exploratory, Open-Lael Study to Assess the Effects of AZD2171 on Tumors and Biomarkers in Patients With Previously Untreated or Recurrent Non-small Cell Lung Cancer (NSCLC) or Patients With Metastatic or Recurrent Head and Neck Cancer (HNC)


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung Carcinoma, Head and Neck Neoplasms

Thank you

Trial Information

An Exploratory, Open-Lael Study to Assess the Effects of AZD2171 on Tumors and Biomarkers in Patients With Previously Untreated or Recurrent Non-small Cell Lung Cancer (NSCLC) or Patients With Metastatic or Recurrent Head and Neck Cancer (HNC)


Inclusion Criteria:



- Histologically or cytologically confirmed head and neck cancer (HNC) or unresectable
stage IIIb or IV non-small cell lung cancer (NSCLC)

- At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET
Scan

- Considered suitable for treatment of NSCLC with no prior biological or immunological
therapy for disease

- Or considered suitable for treatment for metastatic or recurrent HNC with no prior
biological or immunological therapy for disease

Exclusion Criteria:

- NSCLC: Have received more than 2 previous chemotherapy regimens or have received the
last chemotherapy or radiotherapy within 28 days of first dose of AZD2171

- HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of
AZD2171

- Untreatable, unstable brain or meningeal metastases.

- Abnormal liver and kidney blood chemistries

- History of poorly controlled hypertension with resting blood pressure of >150/100

- Recent (< 14 days) major surgery or a surgical incision not fully healed

- Diabetes patients with type I insulin dependent diabetes or poorly controlled type II

- Significant hemorrhage or hemoptysis

- Presence of necrotic/hemorrhagic tumor or metastases

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

AstraZeneca Oncology Medical Sciences Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D8480C00015

NCT ID:

NCT00243347

Start Date:

December 2005

Completion Date:

July 2009

Related Keywords:

  • Carcinoma
  • Non-Small-Cell Lung Carcinoma
  • Head and Neck Neoplasms
  • RECENTIN
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Head and Neck Neoplasms
  • Lung Neoplasms

Name

Location

Research SiteAbilene, Texas