Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Selumetinib (AZD6244), Selumetinib, ARRY-142886, rifampicin, selumetinib (oral)
AZD6244 · 31 trials · 44 indications
Objective response rate is defined as the proportion of participants who have a confirmed CR (defined as disappearance of the target PN, confirmed by a consecutive scan within 3 to 6 months after the first response) or confirmed PR (defined as a target PN volume decrease ≥ 20%, compared to baseline, confirmed by a consecutive scan within 3 to 6 months after the first response) by end of Cycle 16 as determined by ICR per REiNS criteria. Increase in the volume of the target PN by 20% or more compared to baseline or the time of best response after documenting a PR is considered as PD.
Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Partial response is defined as the sum volume of VS decrease ≥20% compared to baseline, confirmed by a consecutive scan after 1 to 3 treatment cycles after the first response. Complete response is defined as disappearance of VS, confirmed by a consecutive scan after 1 to 3 treatment cycles after the first response;
Percentage of participants with WRS improvement exceeding the 95% critical difference from baseline in the ear associated with the target vestibular schwannoma.
Percentage of participants with a PTA decrease of at least 10 dB from baseline in the ear associated with the target vestibular schwannoma.
Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): \>= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.
Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.
The TTD (days) was calculated as the interval from date of randomisation to date of patient death (from any cause). Patients who had not died at the time of the final analysis were censored at the last date the patient was known to be alive. Median TTD in days is presented here.
Determination of the maximum administered dose and the recommended phase II dose
To determine the pharmacokinetics of selumetinib after administration of the selumetinib granule formulation
To assess the safety and tolerability of the selumetinib granule formulation.
To compare the AUC0-12, SS of the fed (same dose and dose adjustment if necessary) versus fasted state
To investigate the gastrointestinal toxicities of selumetinib capsules after multiple doses
To investigate the gastrointestinal toxicities of selumetinib capsules after multiple doses
To investigate the gastrointestinal toxicities of selumetinib capsules after multiple doses
Collecting gastrointestinal concomitant medications taken including, but not restricted to, medications used to treat diarrhoea, nausea and vomiting.
Collecting gastrointestinal concomitant medications taken including, but not restricted to, medications used to treat diarrhoea, nausea and vomiting.
* Occurrence/frequency. * Relationship to IP as assessed by investigator. * Common Terminology Criteria for Adverse Events (CTCAE) grade. * Seriousness. * Death. * Adverse events leading to discontinuation of IP. * Adverse events of special interest.
AUC0-t after single dose and multiple doses administration
Cmax after single dose and multiple doses administration
t1/2 after single dose and multiple doses administration
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms, safety laboratory parameters, echocardiogram and ophthalmologic assessment.
MTD defined by dose limiting toxicities (DLTs) that occur during the first 4 weeks of therapy and are related to the study medications. Grading of DLTs follow the guidelines provided in the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Samples taken during each of the 6 treatments
Change from baseline in QTcF at 30 minutes (msec)
This will be taken at visit 2 for Healthy volunteers and at visit 2 and 3 for patients with end stage renal disease
This will be taken at visit 2 for Healthy volunteers and at visit 2 and 3 for patients with end stage renal disease
This will be taken at visit 2 for Healthy volunteers and at visit 2 and 3 for patients with end stage renal disease
Samples taken during each of the 3 treatments
Curve taken during each of the 2 treatments
Any toxicity not attributable to the disease or disease-related processess under investigation, considered related to the combination of chemotherapy plus selumetinib, which occurs within the timeframe and is dose limiting
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Incidence and intensity of adverse events as graded by CTCAE (version 3.0), physical examinations, vital signs (including weight, blood pressure and pulse rate), ECG parameters, MUGA scan and echocardiography, clinical chemistry (including liver function tests), Brain Natriuretic Peptide (BNP), Troponin I, hematology, urinalysis, and ophthalmologic examinations.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of hematology, clinical chemistry, and urinalysis.
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (blood pressure, oxygen saturation, weight, and pulse rate).
Number of participants with abnormal ECHO parameters reported as TEAEs are reported.
Number of participants with abnormal ECG parameters reported as TEAEs are reported.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Selumetinib |
| Arm B | PLACEBO_COMPARATOR | Placebo |
| selumetinib 75mg twice daily | EXPERIMENTAL | selumetinib 75mg twice daily in combination with dacarbazine. |
| placebo twice daily | PLACEBO_COMPARATOR | placebo twice daily in combination with dacarbazine. |
| Selumetinib + Docetaxel | EXPERIMENTAL | Three 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle |
| Placebo + Docetaxel | EXPERIMENTAL | Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. |
| Selumetinib | EXPERIMENTAL | Selumetinib will be administered at a dose of 25 mg/m²orally twice daily (BID),with a maximum single dose of 50 mg per administration.Doses will be calculated based on body surface area (BSA)and rounded to the nearest 5 mg increment. |
| Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2 | EXPERIMENTAL | Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. |
| Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2 | EXPERIMENTAL | Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle. |
| Placebo twice daily + Docetaxel 75 mg/m2 | EXPERIMENTAL | Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. |
| 1 | EXPERIMENTAL | Selumetinib (AZD6244) in combination with irinotecan |
| 2 | PLACEBO_COMPARATOR | Placebo in combination with dacarbazine |
| AZD6244 + Docetaxel | ACTIVE_COMPARATOR | AZD6244 75 mg bd + Docetaxel 75 mg/m\^2 |
| Paclitaxel and carboplain plus selumetinib | EXPERIMENTAL | Cohort 1: Standard Chemotherapy (paclitaxel and carboplatin) plus selumetinib If you are registered to Cohort 1, you will receive two commonly-used chemotherapy drugs called paclitaxel and carboplatin, plus you will be given the experimental drug selumetinib. |
| pemetrexed and cisplain plus selumetinib | EXPERIMENTAL | Cohort 2: Standard Chemotherapy (pemetrexed and cisplatin) plus selumetinib (cohort closed) If you are registered to Cohort 2, you will receive two commonly-used chemotherapy drugs called pemetrexed and cisplatin, plus you will be given the experimental drug selumetinib. |
| pemetrexed plus selumetinib | EXPERIMENTAL | Cohort 3: Standard Chemotherapy (pemetrexed) plus selumetinib (cohort closed) If you are registered to Cohort 3, you will receive one commonly-used chemotherapy drug called pemetrexed, plus you will be given the experimental drug selumetinib. |
| Selumetinib single arm | EXPERIMENTAL | This study consists of a screening period (up to 28 days), a treatment period (25 cycles) and a long term safety follow-up for participants until they are 5 years old or commence an alternative systemic NF1-PN treatment, whichever is the earlier. Participants may continue treatment with selumetinib throughout the long term safety follow-up as long as they are considered to be receiving clinical benefit in the opinion of their Investigator. A safety follow up assessment will be performed 30 days after the last dose of study intervention for all study participants. |
| Selumetinib + Olaparib | EXPERIMENTAL | Dose Escalation Phase: Participants take both Selumetinib and Olaparib by mouth 2 times each day, about 12 hours apart at the Starting Dose Level. Treatment cycle is 28 days. When maximum tolerated dose reached, Dose Expansion Phase begins. |
| Ovarian Cancer with RPA | EXPERIMENTAL | Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase. |
| Endometrial Cancer with RPA | EXPERIMENTAL | Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase. |
| Ovarian Cancer-Progression-prior PARP Treatment | EXPERIMENTAL | Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase. |
| Solid Tumors that Harbor Somatic RPA | EXPERIMENTAL | Dose Expansion Phase: Selumetinib + Olaparib taken at the maximum tolerated dose from Dose Escalation Phase. |
| Dose escalation: Selumetinib+MEDI4736 | EXPERIMENTAL | An oral formulation of selumetinib will be administered in combination with an IV dose of MEDI4736. 4 cohorts of double combination (Selumetinib+MEDI4736). The decision to escalate to the next dose level/cohort will be made by the Safety Review Committee (SRC) following the completion of the dose limiting toxicity (DLT) assessment period for at least 3 evaluable patients in each cohort. |
| Mandatory paired biopsy expansion cohort: Selumetinib+MEDI4736 | EXPERIMENTAL | One or more independent mandatory paired biopsy expansion cohorts for double combination treatment will start after safety and tolerability have been established for the relevant dose. It will be tumour-type specific for double combination, the tumor type will be determined from emerging data. |
| Dose escalation: Selumetinib+MEDI4736+tremelimumab | EXPERIMENTAL | An oral formulation of selumetinib will be administered in combination with an IV dose of MEDI4736 and an IV dose of tremelimumab. For triple combination treatment, the starting dose of selumetinib (DL1) will be determined by the SRC based on emerging data from dose escalation cohorts of double combination treatment. |
| Mandatory paired biopsy expansion cohort: triple combination | EXPERIMENTAL | One or more independent mandatory paired biopsy expansion cohorts for triple combination treatment will start after safety and tolerability have been established for the relevant dose. It will be tumour-type specific for triple combination, the tumor type will be determined from emerging data. |
| selumetinib; itraconazole; selumetinib + itraconazole | EXPERIMENTAL | Volunteers will receive selumetinib 25mg alone; itraconazole 200mg pre-dosing; selumetinib 25mg and itraconazole 200mg; all adminstered by mouth as a capsule |
| selumetinib; fluconazole; selumetinib + fluconazole | EXPERIMENTAL | Volunteers will receive selumetinib 25mg alone administered by mouth as a capsule; fluconazole 400mg and fluconazole 200mg pre-dosing, administered by mouth as a tablet; selumetinib 25mg and fluconazole 200mg. |
| Selumetinib 75mg | EXPERIMENTAL | Volunteers will receive selumetinib 75mg administered by mouth, as a capsule |
| Moxifloxacin 400 mg | ACTIVE_COMPARATOR | Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule |
| Selumetinib 75mg placebo | PLACEBO_COMPARATOR | Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule. |
| HV selumetinib Stage 1 | EXPERIMENTAL | Healthy volunteer (HV)group to receive selumetinib 50mg (2x25mg) orally |
| ESRD selumetinib Stage 1 | EXPERIMENTAL | End stage renal disease (ESRD)patients to recieve selumetinib 50mg (2x25mg) orally |
| Selumetinib stage 2 | EXPERIMENTAL | If deemed necessary patients with mild and/or moderate and/or severe renal impairment will recieve selumetinib 50mg(2x25mg) orally |
| Selumetinib HV | EXPERIMENTAL | Healthy volunteers (HV) |
| Selumetinib mild impairment | EXPERIMENTAL | Mild (Child Pugh A) hepatic impaired patients |
| Selumetinib moderate impairment | EXPERIMENTAL | Moderate (Child Pugh B) hepatic impaired patients |
| Selumetinib severe impairment | EXPERIMENTAL | Severe (Child Pugh C) hepatic impairment patients |
| selumetinib 75mg. | EXPERIMENTAL | Volunteers will receive selumetinib 75mg administered by mouth, as a capsule |
| rifampicin 600mg. | OTHER | Volunteers will receive rifampicin 600mg administered by mouth, as a capsule |
| selumetinib 75mg and rifampicin 600mg | EXPERIMENTAL | Volunteers will receive selumetinib 75mg and rifampicin 600mg, by mouth, as a capsule |
| selumetinib 75mg (oral capsule fasted) | EXPERIMENTAL | Volunteers will recieve selumetinib 75mg administered by mouth, as a capsule, in a fasted state. |
| selumetinib 75mg (oral capusle fed) | EXPERIMENTAL | Volunteers will receive selumetinib 75mg administered by mouth, as a capsule, in a fed state. |
| [C14] selumetinib 75mg single dose | EXPERIMENTAL | \[C14\] selumetinib 75mg single dose |
| Selumetinib+standard chemotherapy | EXPERIMENTAL | Selumetinib plus gemcitabine; or pemetrexed and cisplatin or carboplatin |
| Selumetinib (AZD6244) 25 mg | EXPERIMENTAL | monotherapy |
| Selumetinib (AZD6244) 50 mg | EXPERIMENTAL | monotherapy |
| Selumetinib (AZD6244) 75 mg | EXPERIMENTAL | monotherapy |
| Selumetinib (AZD6244) 75 mg + Doce | EXPERIMENTAL | Combination |
| Selumetinib (AZD6244) 25 mg + Doce | EXPERIMENTAL | combination |
| 3 | EXPERIMENTAL | AZD6244 + Erlotinib |
| 4 | EXPERIMENTAL | AZD6244 + Temsirolimus |
| Part A: Dose Escalation AZD6244 25 mg | EXPERIMENTAL | Participants will receive a single oral dose of AZD6244 25 mg capsule on Day 1 followed by continuous twice daily (bd) dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first. |
| Part A: Dose Escalation AZD6244 50 mg | EXPERIMENTAL | Participants will receive a single oral dose of AZD6244 50 mg capsule on Day 1 followed by continuous dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first. |
| Part A: Dose Escalation AZD6244 75 mg | EXPERIMENTAL | Participants will receive a single oral dose of AZD6244 75 mg capsule on Day 1 followed by continuous dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first. |
| Part A: Dose Escalation AZD6244 100 mg | EXPERIMENTAL | Participants will receive a single oral dose of AZD6244 100 mg capsule on Day 1 followed by continuous dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first. |
| Part B: Relative Bioavailability (Sequence 1) and Safety Assessment Phase | EXPERIMENTAL | Participants in relative bioavailability phase will receive a single oral dose of AZD6244 100 mg free-base suspension (mix and drink) on Day 1. Following a washout period of 7 days, participants will receive a single oral dose of AZD6244 75 mg capsule on Day 8 (Sequence 1). In the safety assessment phase, participants who will participate in the relative bioavailability phase will receive oral AZD6244 75 mg capsule bd dosing from Day 9 onwards until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first. |
| Part B: Relative Bioavailability (Sequence 2) and Safety Assessment Phase | EXPERIMENTAL | Participants in relative bioavailability phase will receive a single oral dose of AZD6244 75 mg capsule on Day 1. Following a washout period of 7 days, participants will receive a single oral dose of AZD6244 100 mg free-base suspension (mix and drink) on Day 8 (Sequence 2). In the safety assessment phase, participants who will participate in the relative bioavailability phase will receive oral AZD6244 75 mg capsule bd dosing from Day 9 onwards until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first. |
| Name | Type | Description |
|---|---|---|
| Selumetinib | DRUG | Selumetinib oral capsules (10 mg and 25 mg) |
| Placebo | OTHER | Placebo oral capsules for Selumetinib masking (10 mg and 25 mg) |
| 75mg selumetinib | DRUG | selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle. |
| Dacarbazine | DRUG | dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily. |
| Docetaxel | DRUG | Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. |
| Pegylated G-CSF | DRUG | All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration. |
| Selumetinib 75 mg | DRUG | Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule. |
| Docetaxel 75 mg/m2 | DRUG | Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. |
| Docetaxel 60 mg/m2 | DRUG | Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. |
| AZD6244 | DRUG | 50 or 75mg, capsules, PO, BID, 28 days |
| Irinotecan | DRUG | 180mg/m2, IV, Day 1\& 15 of each cycle |
| Capecitabine | DRUG | oral tablet |
| Pemetrexed | DRUG | oral |
| Temozolomide | DRUG | oral |
| Paclitaxel | DRUG | - |
| Carboplatin | DRUG | - |
| Cisplatin | DRUG | - |
| Selumetinib granule formulation | DRUG | Selumetinib granule formulation will be administered using BSA-based dosing. The granule formulation dose schema to be used in the study will be established in the dose finding phase. At enrolment participants must have a BSA within the range 0.40 to 1.09 m2; once participants attain a BSA between 1.10 and 1.29 m2 they will be encouraged to transition to the capsule formulation, if feasible, although all participants must remain on the granule formulation until after they have completed their third cycle of treatment. |
| Selumetinib capsule formulation | DRUG | Selumetinib capsule formulation will be administered using BSA-based dosing. Once participants attain a BSA between 1.10 and 1.29 m2 they will be encouraged to transition to the capsule formulation, if feasible, although all participants must remain on the granule formulation until after they have completed their third cycle of treatment. |
| Olaparib | DRUG | Dose Escalation Phase Starting Dose: 150 mg by mouth twice a day on Days 1-28. Dose Expansion Phase Starting Dose: Maximum tolerated dose from Dose Escalation Phase. |
| MEDI4736 | DRUG | MEDI4736 IV |
| Tremelimumab | DRUG | Tremelimumab, IV |
| itraconazole | DRUG | Volunteers will receive oral doses of itraconazole 200 mg twice daily on Day 1 to Day 7 in sequence 1 treatment B: |
| fluconazole | DRUG | Volunteers will recieve a single dose of 400 mg fluconazole on Day 1 and daily doses of 200 mg fluconazole on Day 2 to Day 7; sequence 2 treatment D. |
| Moxifloxacin | DRUG | Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B) |
| selumetinib placebo | DRUG | Volunteers will receive selumetinib placebo oral dose (Treatment C) |
| Selumetinib 50mg | DRUG | HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1 |
| Selumetinib 25mg | DRUG | Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1 |
| rifampicin | DRUG | Volunteers will receive single, daily, oral doses of 600 mg rifampicin on Days 4 to 11 (Treatment B). |
| selumetinib (oral) | DRUG | Volunteers will receive: 75 mg selumetinib oral dose in a fasted state (Treatment A) followed by a second 75 mg selumetinib oral dose in the fed state (Treatment B) with a washout period of at least 7 days between doses, or: 75 mg selumetinib oral dose in the fed state (Treatment B) followed by a second 75 mg selumetinib oral dose in the fasted state (Treatment A) with a washout period of at least 7 days between doses. |
| [C14] selumetinib (oral) | DRUG | Single oral administration \[C14\] 75mg |
| gemcitabine | DRUG | 1250 mg/m2 iv on Day 1 and 8 of each 21 day cycle. If combination not tolerated, option to give 1000 mg/m2 iv on Day 1 and Day 8 of each 21 day cycle |
| Erlotinib | DRUG | daily oral dose |
| Temsirolimus | DRUG | intravenous infusion |
Key Inclusion Criteria: * Adults ≥ 18 years at enrollment with diagnosis of NF1 with symptomatic, inoperable PN * At least one inoperable target PN measurable by volumetric MRI analysis * Chronic target PN pain score documented for minimum period during screening period * Stable chronic PN pain med...
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AZD6244 is an investigational small molecule being studied in oncology for multiple solid tumors, including non-small cell lung cancer, breast cancer, melanoma, pancreatic cancer, metastatic colorectal cancer, and other neoplasms. It is currently in Phase 1 clinical development and has not been approved by the FDA.
AZD6244 is a small molecule that targets the MEK pathway, a key signaling route involved in cell growth and proliferation. By inhibiting this pathway, it aims to slow tumor progression in cancers such as non-small cell lung cancer and melanoma.
AZD6244 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for oncology indications.
AZD6244 is currently in Phase 1 clinical development. It has completed several Phase 2 trials, but the most recent studies are Phase 1, and the drug remains investigational and not yet approved for any indication.
AZD6244 has been studied in several clinical trials, including NCT00372788 in non-small cell lung cancer, NCT00372944 in pancreatic cancer, NCT00514761 in metastatic colorectal cancer, and NCT01605916 in advanced solid malignancies. These trials are all completed.
AZD6244 is also known as selumetinib, a MEK inhibitor developed by AstraZeneca. It has been investigated in various cancers, including non-small cell lung cancer and pancreatic cancer, and remains in clinical development.