Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00063219
• Date of registration: 23/06/2003
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
• Scientific title: A Phase 2, Open-label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
• Date of first enrolment: May 2003
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00063219
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Medical Monitor, MD
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen
containing a platinum agent

- Recovery from all acute side effects of prior therapies (with the exception of hair
loss)

- Adequate bone marrow, liver, and kidney function

Exclusion Criteria:

- More than 2 prior chemotherapy regimens for treatment of advanced or metastatic
non-small cell lung cancer. (Treatment given in conjunction with surgery will not be
included in the maximum of 2 prior regimens)

- Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of
beginning study

- Symptomatic brain metastases



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Intervention(s)

Drug: MAC-321

Secondary ID(s)

3128K1-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors