A Phase 2 Study of ACR-368 Therapy in Subjects with Endometrial Cancer

Conditions

Endometrial cancer

Brief summary

Confirmed ORR in subjects per RECIST v1.1 by CT scan and/or MRI.

Detailed description

Incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment. Changes in clinical laboratory parameters, vital signs, ECG parameters, and physical examination findings., DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . PFS and OS based on analysis of Kaplan-Meier estimates by CT scans and/or MRI . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. Progression-free rate at 6 months and OS at 6, 9, and 12 months, by CT scans and/or MRI., Confirmed ORR in subjects per RECIST v1.1 by CT scans and/or MRI. DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. PFS based on analysis of Kaplan-Meier estimates., Change from Baseline in NRS and FACIT questionnaire scores.

Related papers

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Interventions

DRUGGEMZAR 200 mg

DRUGpoudre pour solution pour perfusion

DRUGACR-368

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Confirmed ORR in subjects per RECIST v1.1 by CT scan and/or MRI.	—

Secondary

Measure	Time frame
Incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment. Changes in clinical laboratory parameters, vital signs, ECG parameters, and physical examination findings., DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . PFS and OS based on analysis of Kaplan-Meier estimates by CT scans and/or MRI . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. Progression-free rate at 6 months and OS at 6, 9, and 12 months, by CT scans and/or MRI., Confirmed ORR in subjects per RECIST v1.1 by CT scans and/or MRI. DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. PFS based on an	—

Measure

Time frame

Incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment. Changes in clinical laboratory parameters, vital signs, ECG parameters, and physical examination findings., DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . PFS and OS based on analysis of Kaplan-Meier estimates by CT scans and/or MRI . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. Progression-free rate at 6 months and OS at 6, 9, and 12 months, by CT scans and/or MRI., Confirmed ORR in subjects per RECIST v1.1 by CT scans and/or MRI. DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. PFS based on an

—

Outcome results

None listed