AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Participants With Advanced Solid Malignancies

Condition(s) studied

Investigational drug(s) / intervention(s)

AZD6244: Participants will receive single oral dose of AZD6244 as described in arm description.

Study summary

The primary purpose of the study is to assess the safety, tolerability and pharmacokinetics of a capsule of AZD6244 in participants with advanced solid malignancies

Eligibility

Primary outcome measure(s)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Part A and Part B — Day 1 through 11.8 months (maximum observed duration)
  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 in Part A and Part B — Day 1 through 11.8 months (maximum observed duration)
  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 in Part A and Part B — Day 1 through 11.8 months (maximum observed duration)
  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 Echocardiogram (ECHO) Parameters Reported as TEAEs in Part A and Part B — Day 1 through 11.8 months (maximum observed duration)
  Number of participants with abnormal ECHO parameters reported as TEAEs are reported.
• Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Part A and Part B — Day 1 through 11.8 months (maximum observed duration)
  Number of participants with abnormal ECG parameters reported as TEAEs are reported.

Trial sites (4)

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