Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ZD1839 (IRESSA™), ZD1839 (Gefitinib), IRESSA, gefitinib, gefitinib (Iressa)
ZD1839 · 57 trials · 37 indications
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.
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.
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.
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
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.
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.
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 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 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 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
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
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.
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
To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer
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.
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
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
| Arm | Type | Description |
|---|---|---|
| Gefitinib | EXPERIMENTAL | Gefitinib and cisplatin plus pemetrexed combination chemotherapy |
| Placebo | PLACEBO_COMPARATOR | Placebo and cisplatin plus pemetrexed combination chemotherapy. |
| 1 | EXPERIMENTAL | gefitinib |
| 2 | ACTIVE_COMPARATOR | Carboplatin/Paclitaxel |
| Gefitinib (ZD1839) | EXPERIMENTAL | ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial |
| A | EXPERIMENTAL | Gefitinib |
| B | EXPERIMENTAL | Gemcitabine |
| C | EXPERIMENTAL | Docetaxel |
| Gefitinib with a Seq. Switch to a MEDI4736 | EXPERIMENTAL | Gefitinib once daily followed by MEDI4736 |
| AZD9291 with a Seq. Switch to a MEDI4736 | EXPERIMENTAL | AZD9291 once daily followed by MEDI4736 |
| Selumetinib+Docetaxel with a Seq. Switch to a MEDI4736 | EXPERIMENTAL | Selumetinib twice daily + docetaxel, followed by MEDI4736 |
| Tremelimumab with a Seq. Switch to a MEDI4736 | EXPERIMENTAL | Tremelimumab every 4 weeks followed by MEDI4736 |
| open label single arm with Gefitinib 250MG once daily | EXPERIMENTAL | Gefitinib 250 mg/day open label until progression disease / toxicity / consent withdrawal |
| 3 | EXPERIMENTAL | 500 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy |
| 4 | EXPERIMENTAL | gefitinib 250 mg + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy |
| 5 | EXPERIMENTAL | gefitinib 500 mg + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy |
| 6 | PLACEBO_COMPARATOR | placebo + cisplatin + radiotherapy; followed by gefitinib 250 mg as maintenance therapy |
| 7 | PLACEBO_COMPARATOR | placebo + cisplatin + radiotherapy; followed by gefitinib 500 mg as maintenance therapy |
| Anastrozole-placebo | ACTIVE_COMPARATOR | Anastrozole (ZD1033, Arimidex)-Placebo |
| Anastrozole-ZD1839 | ACTIVE_COMPARATOR | Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA) |
| Taxotere® (Docetaxel) + ZD1839 (IRESSA®) | EXPERIMENTAL | Patients 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. |
| Escalation | EXPERIMENTAL | MEDI4736 will be combined with gefitinib to assess safety and tolerability |
| Expansion Arm | EXPERIMENTAL | MEDI4736 will be combined with gefitinib |
| Treatment | EXPERIMENTAL | * 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 1 | EXPERIMENTAL | post operative combination of gefinib and RT |
| Cohort 2 | EXPERIMENTAL | combination of gefitinib with RT and Chemotherapy in non operated patients |
| Name | Type | Description |
|---|---|---|
| Gefitinib | DRUG | Investigational Drug |
| Placebo | DRUG | Matching placebo as comparator |
| Pemetrexed | DRUG | Chemotherapy (concomitant therapy) |
| Cisplatin | DRUG | Chemotherapy (concomitant therapy) |
| Carboplatin | DRUG | IV |
| Paclitaxel | DRUG | IV |
| Docetaxel | DRUG | intravenous infusion |
| methotrexate | DRUG | - |
| ZD1839 (Gefitinib) | DRUG | - |
| Gefitinib (Iressa) | DRUG | Iressa |
| Fluorouracil | DRUG | - |
| gemcitabine | DRUG | 1250 mg/m² D1 and D8 (D1=D28, until progression) |
| AZD9291 | DRUG | AZD9291 once daily followed by MEDI4736 |
| Selumetinib+Docetaxel | DRUG | Selumetinib twice daily + docetaxel, followed by MEDI4736 |
| Tremelimumab | DRUG | Tremelimumab every 4 weeks followed by MEDI4736 |
| Gefitinib 250mg | DRUG | Gefitinib 250mg once daily |
| radiotherapy | RADIATION | radiation therapy |
| Radiation therapy | PROCEDURE | - |
| Vinorelbine | DRUG | - |
| gefitinib and fulvestrant | DRUG | - |
| 5-flourouracil | DRUG | - |
| Anastrozole | DRUG | 1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO |
| Iressa | DRUG | - |
| Gefitinib, raltitrexed | DRUG | - |
| Tamoxifen | DRUG | - |
| ZD1839 | DRUG | 250mg tablet, once daily, orally administered |
| docetaxel (Taxotere®) | DRUG | Taxotere® 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 Radiotherapy | DRUG | - |
| gefitinib (IRESSA™, ZD1839) | DRUG | 250 mg tablet; daily dose 500 mg daily |
| Bexarotene | DRUG | - |
| MEDI4736 | DRUG | MEDI4736 IV Q2W |
| palliative thoracic radiotherapy | PROCEDURE | - |
| Gefitinib and capecitabine | DRUG | - |
| Gefitinib, radiotherapy | DRUG | - |
| Radiation | PROCEDURE | - |
| ZD-1839 | DRUG | - |
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...
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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.
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.
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.
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.
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.
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.