NCT01693562 · OUTCOME

Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

A Phase 1/2 Study to Evaluate MEDI4736 · Source last updated 2021-05-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From Baseline (Day 1) through 90 days after the last dose of study drug (approximately 5.25 years)

What was measured

Number of participants with change from baseline in notable QT/QTc interval in local electrocardiogram (ECG) are reported. The data for \>0 participants with notable QT/QTc interval in local ECG from baseline are reported.

Analysis population: As-treated population included all participants who received any dose of study drug were analyzed. Participants with ECG readings available were evaluable for this analysis. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class.

Groups in this outcome

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)

Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)

Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first

Escalation Cohort (MEDI4736 1 mg/kg Q2W)

Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 3 mg/kg Q2W)

Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.

Escalation Cohort (MEDI4736 15 mg/kg Q3W)

Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Exploration Cohort (MEDI4736 20 mg/kg Q4W)

Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)

Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation , whichever occurred first.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.