Recent Updates
Recently added Catalysts

ZD-1839

Phase 2

Head and Neck Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 27, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

ZD-1839 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00242762ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck CancerHead and Neck Cancer
COMPLETED36 Analytics
PHASE2COMPLETED
ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck Cancer
Head and Neck CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)
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

PFS
Overall survival
Incidence of DLT during the first cycle of study treatment
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
ZD1839 (IRESSA™)DRUG -
DocetaxelDRUG -
CisplatinDRUG -
ZD-1839DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Male or female, aged 18 and 70 years, inclusive 2. Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN 3. Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx 4. At least one uni-dimensionally measurable lesion according to the RECIST...

Countries:SpainUnited States
Unlock Eligibility Criteria

Frequently asked questions about ZD-1839

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.