Recent Updates
Recently added Catalysts

ZD1839

Phase 4FDA approved 2003

Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Trials Updated: Mar 8, 2024

ZD1839 development status

FDA approval May 5, 2003 as Iressa
Approval holderAstrazeneca
ApplicationNDA021399
Highest phase Phase 4 (NCT00608868)
Phase scored for AZNPhase 3
Registered trials 101 across 32 sponsors since May 2003

ZD1839 target and mechanism

ModalitySmall molecule

Also known as ZD1839 (IRESSA™), ZD1839 (Gefitinib), IRESSA, gefitinib, gefitinib (Iressa)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials57
Total Enrollment9,037

FDA Designations

No designations recorded

ZD1839 clinical trials

ZD1839 · 57 trials · 37 indications

Phase 3 9Phase 2 36Phase 1 12
NCT01544179A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy AloneNon-Small Cell Lung Cancer
COMPLETED265 Analytics
NCT00322452First Line IRESSA™ Versus Carboplatin/Paclitaxel in AsiaNon-Small Cell Lung Cancer
COMPLETED1,329 Analytics
NCT00478049Iressa as Second Line Therapy in Advanced NSCLC-AsiaNSCLC
COMPLETED163 Analytics
NCT00357734Iressa Follow-up TrialLung Cancer
COMPLETED14 Analytics
NCT00076388Iressa Versus Docetaxel (Taxotere)Non-Small-Cell Lung Carcinoma
COMPLETED1,440 Analytics
NCT00206219Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)Squamous Cell Carcinoma of the Head and Neck
COMPLETED477 Analytics
NCT00242801Iressa vs Best Supportive Care - 2nd/3rd Line Survival StudyNSCLC
COMPLETED1,692 Analytics
NCT00034879Iressa Expanded Access Program (EAP)Carcinoma
COMPLETED- Analytics
NCT00635973Open-Label Extension of Other SZ1839 (Iressa) TrialsCancer
COMPLETED100 Analytics
PHASE3COMPLETED
A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone
Non-Small Cell Lung CancerUnlock trial analytics
PHASE3COMPLETED
First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia
Non-Small Cell Lung CancerUnlock trial analytics
PHASE3COMPLETED
Iressa as Second Line Therapy in Advanced NSCLC-Asia
NSCLCUnlock trial analytics
PHASE3COMPLETED
Iressa Follow-up Trial
Lung CancerUnlock trial analytics
PHASE3COMPLETED
Iressa Versus Docetaxel (Taxotere)
Non-Small-Cell Lung CarcinomaUnlock trial analytics
PHASE3COMPLETED
Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)
Squamous Cell Carcinoma of the Head and NeckUnlock trial analytics
PHASE3COMPLETED
Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study
NSCLCUnlock trial analytics
PHASE3COMPLETED
Iressa Expanded Access Program (EAP)
CarcinomaUnlock trial analytics
PHASE3COMPLETED
Open-Label Extension of Other SZ1839 (Iressa) Trials
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (Site Read, Investigator Assessment)
Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks

PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

Median Progression-Free Survival (Site Read, Investigator Assessment)
Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks

PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

Median Progression Free Survival (PFS) in Months
Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).

PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.

Compare progression free survival between patients on gefitinib or on docetaxel by Progression as per Response Evaluation Criteria In Solid Tumors
Survival
Number of Serious Adverse Events (SAEs)
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)

Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease

Number of Serious Adverse Events (SAEs) Related to ZD1839
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)

Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.

Number of Other Adverse Events (AEs)
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)

Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.

Number of Other Adverse Events (AEs) Related to ZD1839
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)

Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.

To compare overall survival between ZD1839 and docetaxel
Compare ZD1839 versus methotrexate in overall survival
The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care
Adverse Events
Every 28 days
Overall response rate
Progression-free Survival (PFS)
week
Confirmed Complete Response (CR) Rate
Up to 2 years

To assess the efficacy of various sequences. CR (per RECIST 1.1 as assessed by the local/site Investigator) is defined as the disappearance of all target and non-target lesions. Confirmed complete response rate (CR rate) is defined as the number (%) of patients with a confirmed overall response of CR and was based on the evaluable analysis set.

Objective Response Rate
every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)

Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response. Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),\>=30% decrease in the sum of longest diamteter of target lesions; Objective response rate (RR)=CR+PR

Clinical Benefit Rate
every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)

Clinical benefit rate is the sum of patients with a best visit response of Complete Response, Partial Response or Stable Desease Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response. Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),\>=30% decrease in the sum of longest diamteter of target lesions, Stable Desease (SD) defined as no progression for\>= 6 weeks. Objective response rate (RR)=CR+PR

Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
baseline to 12 months

Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria

Disease control rate after 3 months of treatment
Month
Local Disease Control Rate at 2 Years
Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).

A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.

the complete pathological response rate in the two study groups at trial closure
Progression Free Survival (PFS)
Date of randomization to earliest date of objective disease progression

Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression

Ascertain the median survival of advanced pancreatic cancer patients treated with Gefitinib and docetaxel.
To compare Iressa v best supportive care in terms of progression free survival
Progression-free survival
To determine the disease control rate in these patients
To estimate the objective response rate in patients treated with this drug
To compare ZD1839 and vinorelbine in terms of progression free survival
To study the effect of Iressa on gene expression profiles in patients with head and neck cancer
To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients
Time to progression
Duration of study

To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer

PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)
Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
Determine the progression free survival
Strata 1: To compare the time to progression between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
Time to progression (progressive disease or death; equivalent to progression-free survival)
Strata 2: To compare the clinical benefit rate between 2 treatment arms (ZD1839/Nolvadex vs placebo/Nolvadex)
Overall clinical benefit rate: Complete Response, Partial Response or Stable Disease > 24weeks after each combination
To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure
Proportion of patients responding at trial closure, ITT population
To further characterize the safety profile of ZD1839 at a 250mg daily dose
Proportion of patients responding at trial closure, ITT population
Overall Response Rate (ORR)
Duration of time on study, an average of 19 months

ORR: Complete Response (CR) + Partial Response (PR). Response rate for Elderly (\> 70 years) previously untreated patients with Stage IIIb (With Malignant Pleural Effusion (MPE)) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): \* Complete Response (CR)- Disappearance of all target lesions; \* Partial Response (PR)- At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; \* Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; \* Stable Disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)
Molecular alterations occuring in breast cancer tissue following Iressa treatment
At time of diagnosis and time of patient surgery
Objective tumour response (CR + PR) per RECIST criteria
To evaluate the combination of docetaxel and ZD1839 on pathologic complete response (pCR) in radical prostatectomy specimens. Pathological complete response is defined as no microscopic evidence of neoplastic cells in the resected specimen.
Time to progression (TTP)
Objective tumour response at 6 months after the end of combination treatment by computerized tomography scan or magnetic resonance imaging of the brain according to Macdonald criteria.
The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate
Disease-free survival at 2 years
To estimate the overall response rates (complete response [CR] and partial response [PR]) in the ZD1839-treated group and the placebo-treated group.
Serum Prostate Specific Antigen
Monthly
Objective tumour response (complete + partial response) based on Union International Contre le Cancer (UICC) Criteria
Assessed after 24 weeks
Clinical benefit (CR + PR + SD > 24 wks)
After 24 weeks of treatment
Frequency and severity of adverse events (AEs)
Assessed at each visit
Overall response rate (RECIST CRITERIA), time to progression, toxicity
Completed 9/2005
Pharmacokinetic analysis
Completed 12/2005
Median survival
Calculated Spring 2008
Escalation Phase: safety and tolerability: AEs, laboratory data, vital signs, ECG changes and Echo. Expansion Phase: safety and tolerability of the recommended dose for MEDI4736; AEs, laboratory data, vital signs, ECG changes and Echo.
From first dose of study treatment until 90 days after the last dose, assessed up to 32 months

AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\]; Safety Labs: Blood and urine samples for determination of clinical chemistry, hematology, coagulation, thyroid function tests and urinalysis will be taken at the visits; any laboratory abnormalities, and including dose-limiting toxicities (DLTs), ECG measurements and Creatinine Clearance

safety and tolerability of the association between Gefitinib (fixed dose) and Tremelimumab (dose escalation)
Up to 42 days

The primary objective of this phase 1 study is to determine the safety and tolerability of oral Gefitinib in combination with three escalating doses of Tremelimumab and to establish a recommended phase 2 dose. Overall safety profile will be characterized by type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCICTCAE\] Version 4.03), timing of adverse events and laboratory abnormalities in the first and in the following cycles

To characterize the safety profile of ZD 1839 in these patients
Objective tumour response (CR and PR) at study closure based on the RECIST
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
Parts 1 and 2: Safety (Incidence of DLTs)
Part 3: Safety and tolerability
Part A: Safety (incidence of DLTs)
Part B: Tolerability
Incidence of DLT
To determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.
To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD 1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck
no known

Secondary Endpoints

Overall Survival (OS)
Following progression survival data was collected every 8 weeks until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurs first.
Median Overall Survival (OS) at Time of PFS Analysis
Baseline and then every 6 weeks after randomization until objective disease progression. OS is then assessed 8 weekly following PFS progression up to PFS analysis data cut off.
Objective Response Rate (ORR) (Site Read Data)
Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GefitinibEXPERIMENTALGefitinib and cisplatin plus pemetrexed combination chemotherapy
PlaceboPLACEBO_COMPARATORPlacebo and cisplatin plus pemetrexed combination chemotherapy.
1EXPERIMENTALgefitinib
2ACTIVE_COMPARATORCarboplatin/Paclitaxel
Gefitinib (ZD1839)EXPERIMENTALZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
AEXPERIMENTALGefitinib
BEXPERIMENTALGemcitabine
CEXPERIMENTALDocetaxel
Gefitinib with a Seq. Switch to a MEDI4736EXPERIMENTALGefitinib once daily followed by MEDI4736
AZD9291 with a Seq. Switch to a MEDI4736EXPERIMENTALAZD9291 once daily followed by MEDI4736
Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736EXPERIMENTALSelumetinib twice daily + docetaxel, followed by MEDI4736
Tremelimumab with a Seq. Switch to a MEDI4736EXPERIMENTALTremelimumab every 4 weeks followed by MEDI4736
open label single arm with Gefitinib 250MG once dailyEXPERIMENTALGefitinib 250 mg/day open label until progression disease / toxicity / consent withdrawal
3EXPERIMENTAL500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
4EXPERIMENTALgefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
5EXPERIMENTALgefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
6PLACEBO_COMPARATORplacebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy
7PLACEBO_COMPARATORplacebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy
Anastrozole-placeboACTIVE_COMPARATORAnastrozole (ZD1033, Arimidex)-Placebo
Anastrozole-ZD1839ACTIVE_COMPARATORAnastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA)
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)EXPERIMENTALPatients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle. ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
EscalationEXPERIMENTALMEDI4736 will be combined with gefitinib to assess safety and tolerability
Expansion ArmEXPERIMENTALMEDI4736 will be combined with gefitinib
TreatmentEXPERIMENTAL* Cohort 1: Tremelimumab 3 mg/kg every 4 Weeks plus Gefitinib 250 mg/daily, 6 patients (+ 6 patients if 3 mg/kg is the MTD) * Cohort 2: Tremelimumab 6 mg/kg every 4 Weeks plus Gefitinib 250 mg/daily, 6 patients (+ 6 patients if 6 mg/kg is the MTD) * Cohort 3: Tremelimumab 10 mg/kg every 4 Weeks plus Gefitinib 250 mg/daily, 6 patients (+ 6 patients if 10 mg/kg is the MTD)
Cohort 1EXPERIMENTALpost operative combination of gefinib and RT
Cohort 2EXPERIMENTALcombination of gefitinib with RT and Chemotherapy in non operated patients

Interventions

NameTypeDescription
GefitinibDRUGInvestigational Drug
PlaceboDRUGMatching placebo as comparator
PemetrexedDRUGChemotherapy (concomitant therapy)
CisplatinDRUGChemotherapy (concomitant therapy)
CarboplatinDRUGIV
PaclitaxelDRUGIV
DocetaxelDRUGintravenous infusion
methotrexateDRUG -
ZD1839 (Gefitinib)DRUG -
Gefitinib (Iressa)DRUGIressa
FluorouracilDRUG -
gemcitabineDRUG1250 mg/m² D1 and D8 (D1=D28, until progression)
AZD9291DRUGAZD9291 once daily followed by MEDI4736
Selumetinib+DocetaxelDRUGSelumetinib twice daily + docetaxel, followed by MEDI4736
TremelimumabDRUGTremelimumab every 4 weeks followed by MEDI4736
Gefitinib 250mgDRUGGefitinib 250mg once daily
radiotherapyRADIATIONradiation therapy
Radiation therapyPROCEDURE -
VinorelbineDRUG -
gefitinib and fulvestrantDRUG -
5-flourouracilDRUG -
AnastrozoleDRUG1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO
IressaDRUG -
Gefitinib, raltitrexedDRUG -
TamoxifenDRUG -
ZD1839DRUG250mg tablet, once daily, orally administered
docetaxel (Taxotere®)DRUGTaxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
ZD1839 (IRESSA™)DRUG -
Gefitinib, Cisplatin and RadiotherapyDRUG -
gefitinib (IRESSA™, ZD1839)DRUG250 mg tablet; daily dose 500 mg daily
BexaroteneDRUG -
MEDI4736DRUGMEDI4736 IV Q2W
palliative thoracic radiotherapyPROCEDURE -
Gefitinib and capecitabineDRUG -
Gefitinib, radiotherapyDRUG -
RadiationPROCEDURE -
ZD-1839DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites61

Inclusion Criteria: * Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 years or older) * Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally * Pati...

Countries:ChinaFranceGermanyHong KongHungaryItalyJapanRussiaSouth KoreaSpainTaiwanIndonesiaMalaysiaPhilippinesSingaporeThailandUnited StatesArgentinaBelgiumBrazilCanadaCroatiaDenmarkEstoniaLatviaMexicoSloveniaSwedenSwitzerlandTurkey (Türkiye)AustraliaCzechiaGreeceIndiaIsraelLithuaniaNetherlandsNorwaySouth AfricaUnited KingdomBulgariaChileIrelandPeruPolandRomaniaSlovakiaUkraineVenezuelaSerbiaColombiaFinland
Unlock Eligibility Criteria

Frequently asked questions about ZD1839

What is ZD1839?

ZD1839 is an investigational small molecule oncology drug developed by AstraZeneca PLC. It has been studied in several cancer types, including non-small cell lung cancer, head and neck cancer, mesothelioma, and prostate cancer. ZD1839 is also known by the names gefitinib and IRESSA.

What is ZD1839 used for?

ZD1839 has been studied in clinical trials for the treatment of several cancers, including non-small cell lung cancer, head and neck cancer, mesothelioma, and prostate cancer. It is an oncology drug being developed by AstraZeneca PLC and is not described as approved for these uses.

Who makes ZD1839?

ZD1839 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored Phase 2 trials of the drug across multiple cancer types, including non-small cell lung cancer, head and neck cancer, mesothelioma, and prostate cancer.

What phase is ZD1839 in?

ZD1839 is in Phase 3 development according to its development profile, though the individual trials listed for the drug are Phase 2 studies. It is an investigational agent and is not described as FDA approved. AstraZeneca PLC is the developer.

What clinical trials is ZD1839 in?

ZD1839 has been studied in completed Phase 2 trials including NCT00787410 in malignant mesothelioma, NCT00242918 in prostate cancer, NCT00242762 in metastatic head and neck cancer, and NCT00231465 in elderly patients with non-small cell lung cancer. These trials evaluated the drug alone or in combination with docetaxel or cisplatin.

Is ZD1839 the same as gefitinib or IRESSA?

Yes. ZD1839 is the same drug as gefitinib, which is also known by the brand name IRESSA. The names ZD-1839, ZD1839 (IRESSA), and ZD1839 (Gefitinib) all refer to the same AstraZeneca PLC compound studied in non-small cell lung cancer and other solid tumors.