Study Number	Completed Clinical Trial Report Summaries
1839IL/0014	A Randomized, Double-blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA™) in Combination With Gemcitabine and Cisplatin Versus Placebo in Combination With Gemcitabine and Cisplatin in Chemotherapy-naive Patients With Advanced (Stage III or IV) Non-Small Cell Lung Cancer
1839IL/0016	A randomized, double-blind, parallel-group, Phase II, multicenter trial to assess the efficacy of ZD1839 (IRESSA™) 250 and 500 mg/day in patients with advanced non-small-cell lung cancer who have failed one or two previous chemotherapy regimens; at least one having contained platinum
1839IL/0017	A Randomized, Double-blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA™) in Combination With Paclitaxel and Carboplatin Versus Placebo in Combination With Paclitaxel and Carboplatin in Chemotherapy-naive Patients With Advanced (Stage III or IV) Non-Small Cell Lung Cancer
1839IL/0039	A Randomized, Double-blind, Parallel-group, Phase II, Multicenter Trial of Two Doses of ZD1839 (IRESSA™) in Patients With Advanced NSCLC Who Have Previously Received at Least Two Chemotherapy Regimens that Contained Platinum and Docetaxel Given Concurrently or as Separate Treatment Regimens
1839IL/0058	A randomised phase II and pharmacokinetic study of oral ZD1839 given continuously with oxaliplatin or cisplatin in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck.
1839IL_0083	A multicentre, open-label, non-comparative Phase II trial to evaluate the efficacy and safety of ZD1839 (IressaTM) alone as first-line treatment in patients with ER-negative metastatic breast cancer
1839IL/0105	An open-label, non-comparative, phase II trial of ZD1839 (IressaTM) in combination with docetaxel (Taxotere®) in patients with advanced or metastatic non-small cell lung cancer failing or unsuitable for platinum based chemotherapy
1839IL/0120(D7913C00120)	An open, phase II study of ZD1839 (IRESSA™) plus best supportive care (BSC) in chemotherapy-naïve patients ineligible for chemotherapy with advanced (stage IIIB or IV) non-small cell lung cancer.
1839IL/0143	A Randomized, placebo-controlled, double-blind phase IIb study of raltitrexed (Tomudex) and ZD1839 (Iressa) versus raltitrexed alone as second line chemotherapy in subjects with colorectal carcinoma
1839IL/0219(D7917C00219)	A presurgical study to evaluate molecular alterations that occur in human breast cancer tissue and normal skin after short term exposure to ZD1839 (Iressa™) and to correlate these alterations with pharmacokinetic parameters
1839IL/0225 D7917C00225)	A Phase II randomised, double-blind, stratified, multi-centre trial comparing the Nolvadex 20 mg and placebo combination to the Nolvadex 20 mg and ZD1839 (IRESSA™) 250 mg combination in patients with metastatic breast cancer and estrogen receptor (ER) and/or progesterone (PgR) positive tumours
1839US/0040	A phase II, open-label trial to assess the activity of ZD1839 (IRESSA™) in patients with recurrent prostate cancer who have rising serum PSA levels despite serum testosterone < 50 ng/dL
1839IL/0100	A phase I/II trial to evaluate ZD1839 (Iressa™ ) in combination with radiotherapy and gemcitabine as first-line treatment in patients with locally advanced, unresectable pancreatic cancer
D7913C00212	A Phase I, Randomised, Open-label, 2-Way Crossover Study to Assess the Effect of ZD1839 (IRESSA™) on the Anticoagulant Properties and Pharmacokinetics of Warfarin in Healthy Male Subjects
1839IL/0503 D791AC00009	A Phase II, Open-Label, Randomised, Parallel Group, Non Comparative Study of ZD1839 (IRESSA™) and Docetaxel (TAXOTERE®) as Second Line Therapy in Subjects with Advanced (Stage IIIB or IV) Non Small Cell Lung Cancer
1839IL/0505	A Phase I/II, Multicentre Clinical Study Of ZD1839 (Iressa™) In Combination With Capecitabine (Xeloda™) In Subjects With Advanced Colorectal Carcinoma After Failure Of First-Line Chemotherapy
D791AL00002	A nested case-control study to determine the relative risk of and risk factors for interstitial lung disease in a cohort of NSCLC patients treated with and without gefitinib
1839IL/0709	A Double-blind, Placebo-controlled, Parallel-group, Multicentre, Randomised, Phase III Survival Study Comparing ZD1839 (IRESSA™) (250 mg Tablet) plus Best Supportive Care versus Placebo plus Best Supportive Care in Patients With Advanced NSCLC who Have Received One or Two Prior Chemotherapy Regimens and are Refractory or Intolerant to Their Most Recent Regimen
839IL/0710-D7913C00710	A Double Blind, Placebo Controlled, Parallel Group, Multicentre, Randomised Phase III Study of Disease-Related Symptoms Comparing ZD1839 (IRESSA™) (250mg Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Symptomatic Patients with Advanced NSCLC who have Received One or Two Prior Chemotherapy Regimens and are Refractory or Intolerant to Their Most Recent Regimen
D7913C00711	A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo Controlled Study of ZD1839 (Iressa™) (250mg Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy Naïve Patients with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status INSTEP (Iressa NSCLC Trial Evaluating Poor Performance Patients)
D7913L00012	Phase II study of Iressa in relapsed and refractory SCLC
D7913L00088	A phase II exploratory, multicentre, open-label, non-comparative study of ZD1839 (IRESSA™) and radiotherapy in the treatement of patients with Glioblastoma Multiforme
D7913L00524	A phase I study of ZD1839 (IRESSA ™) and palliative thoracic radiotherapy in patients with non-small lung cancer.
D7913L00544	A randomized phase II study to investigate the feasibility and benefits of combining ZD1839 (Iressa™) and cisplatin/ 5FU, as induction therapy, in patients with locally advanced squamous cell carcinoma of the head and neck
D791AL00001 (V-15-32)	A multicentre, randomised, open-label, parallel-group, Phase III postmarketing clinical study to compare the overall survival between gefitinib and docetaxel in patients with advanced or metastatic (Stage IIIB/IV), or recurrent non-small cell lung cancer, who have failed one or two chemotherapy regimens
D7919C00704(IMEX)	A Phase III Randomised, Stratified, Parallel-group, Multi-centre, Comparative Study of Gefitinib (IRESSA®) 250 mg and 500 mg versus Methotrexate for Previously Treated Patients with Squamous Cell Carcinoma of the Head and Neck
D7917C00223	Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®)-Placebo Combination to the Anastrozole –ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women with Stage I-IIIB (tumour ≥2cm) Non Inflammatory Breast Cancer and Oestrogen Receptor (ER) and /or Progesterone Receptor (PgR) Positive Tumours)
1839IL/0539	An open, single-centre, phase I/II study of ZD1839 (IRESSA™) in combination with 5-fluorouracil, leucovorin and radiotherapy in subjects with resectable gastric cance (GC)
1839IL/0081	An open-label, non-comparative phase II trial to evaluate the efficacy and safety of docetaxel (taxotere®) with ZD 1839 (Iressatm) in patients with hormone-refractory metastatic prostate cancer
D791AC00001(INVITE)	A randomised, open label, parallel group, multi-centre, phase II study of progression-free survival comparing ZD1839 (IRESSA™) (250 mg tablet) versus vinorelbine (30 mg/m2 infusion) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC INVITE (Iressa in NSCLC versus Vinorelbine Investigation in The Elderly)
1839LI-0128	A randomised phase II study: Treatment with daily p.o. Iressa (ZD1839) or placebo in combination with weekly IV infusion of docetaxel in patients with metastatic breast cancer.
1839UK/0713	Trial results awaiting further analysis and interpretation. Anticipated posting date is October 2008.