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ZD1839

Phase 3

Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 4, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

ZD1839 · 3 trials · 6 indications

Phase 3 1Phase 2 2
NCT00034879Iressa Expanded Access Program (EAP)Carcinoma
COMPLETED- Analytics
PHASE3COMPLETED
Iressa Expanded Access Program (EAP)
Carcinoma
NCT00034879-
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Study Endpoints

Primary Endpoints

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
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.

Secondary Endpoints

To estimate PFS (progression free survival)
Proportion of patients alive and progression-free at trial closure, ITT population; Median time to progression or death; Proportion of patients alive and progression-free at 6 months
To estimate overall survival
Proportion of patients alive at trial closure, ITT population; Median time to death; Proportion of patients alive at 6 months
To estimate duration of response
Median time from objective response to progression or death; only patients who responded are included in this analysis
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
ZD1839 (Gefitinib)DRUG -
ZD1839DRUG250mg tablet, once daily, orally administered
docetaxelDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites626

Inclusion Criteria For inclusion in this trial, patients must fulfill all of the following criteria: * previous documented histologically or cytologically confirmed non-small cell lung cancer; * locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients wh...

Countries:United States
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Competitive Landscape -Cholangiocarcinoma 58 trials (matched to "Carcinoma")

Top 20 of 23 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN11PHASE3Rilvegostomig, Capecitabine, Gemcitabine/Cisplatin, S-1
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE3Zanidatamab, Cisplatin, Gemcitabine, Pembrolizumab, Durvalumab
Eli Lilly and CompanyLLY4PHASE2Ramucirumab, Merestinib, Cisplatin, Gemcitabine
Tango Therapeutics, Inc.TNGX4PHASE3Ivosidenib
Zymeworks Inc.ZYME1PHASE3Futibatinib, Ivosidenib, Zanidatamab, Trastuzumab, Neratinib
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Pfizer Inc.PFE2PHASE2tucatinib, trastuzumab, fulvestrant
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE2/PHASE3HMPL-453
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
Replimune Group, Inc.REPL1PHASE2RP2, Bevacizumab, Atezolizumab, Durvalumab
Gilead Sciences, Inc.GILD1PHASE2Gemcitabine, Cisplatin, Zimberelimab, Quemliclustat
Incyte CorporationINCY1PHASE2Pemigatinib, Durvalumab
Tyra Bioscience, IncTYRA1PHASE1Phase 1 Part A- dose escalation TYRA-200 taken once daily by mouth in 28-day cycles, Phase 1 Part B- dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
Cogent Biosciences, Inc.COGT1PHASE1CGT4859
Molecular Partners AG Sponsored ADRMOLN1PHASE2MP0317, Gemcitabine, Cisplatine, Durvalumab, Cisplatin
Summit Therapeutics IncSMMT1PHASE2Ivonescimab, FOLFOX regimen
Context Therapeutics, Inc.CNTX1PHASE1CT-95
MacroGenics, Inc.MGNX1PHASE1MGC028
NextCure, Inc.NXTC1PHASE1LNCB74
Precision BioSciences, Inc.DTIL3PHASE1CEA-targeted CAR-T cells
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Frequently asked questions about ZD1839

What is ZD-1839 used for?

ZD-1839 is an investigational small molecule being studied in oncology for the treatment of mesothelioma, prostate cancer, head and neck cancer, and carcinoma. It is being developed by AstraZeneca PLC (AZN) and has completed clinical trials in these indications.

What does ZD-1839 target?

ZD-1839 is a small molecule that targets the epidermal growth factor receptor (EGFR), a protein involved in cell growth and division. By inhibiting EGFR, ZD-1839 aims to slow or stop the growth of cancer cells that rely on this signaling pathway.

Who makes ZD-1839?

ZD-1839 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and effectiveness of ZD-1839 in various cancer types.

What phase is ZD-1839 in?

ZD-1839 is in Phase 2 clinical development. It has completed two Phase 2 trials and one Phase 1 trial, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is ZD-1839 in?

ZD-1839 has completed four clinical trials, including NCT00185835 (Phase 1, head and neck cancer), NCT00242762 (Phase 2, head and neck cancer), NCT00242918 (Phase 2, prostate cancer), and NCT00787410 (Phase 2, mesothelioma). All trials are completed with a total enrollment of 46 patients.

Is ZD-1839 the same as IRESSA?

ZD-1839 is also known as IRESSA, as indicated in the clinical trial titles. IRESSA is the brand name used in studies such as NCT00242762 and NCT00787410. Both names refer to the same investigational drug being developed by AstraZeneca.