NCT03345784 · OUTCOME

Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities

Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers · Source last updated 2024-02-20

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: Up to week 5

What was measured

To determine the recommended phase II dose (RP2D) and safety profile of AZD1775 in combination with radiotherapy and concurrent cisplatin in patients with gynecological cancers.

Analysis population: Participants that were evaluable for response.

Groups in this outcome

Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1

Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 1, 3, and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.

Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1

Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 3 and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.

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

Analysis denominator · Participants

Group	Source count
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1	3
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1	4

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1	NA	Not reported	Not reported	Not reported	Could not be determined due to early study closure (due to clinically significant toxicity, slow accrual and significant adverse events also reported with the combination of AZD1775 and chemoradiation in other studies)
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1	NA	Not reported	Not reported	Not reported	Could not be determined due to early study closure (due to clinically significant toxicity, slow accrual and significant adverse events also reported with the combination of AZD1775 and chemoradiation in other studies)

Complete source fields

classes

categories
measurements
comment
Could not be determined due to early study closure (due to clinically significant toxicity, slow accrual and significant adverse events also reported with the combination of AZD1775 and chemoradiation in other studies)
group Id
OG000
value
NA
comment
Could not be determined due to early study closure (due to clinically significant toxicity, slow accrual and significant adverse events also reported with the combination of AZD1775 and chemoradiation in other studies)
group Id
OG001
value
NA

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
4
units
Participants

description

To determine the recommended phase II dose (RP2D) and safety profile of AZD1775 in combination with radiotherapy and concurrent cisplatin in patients with gynecological cancers.

groups

description
Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 1, 3, and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
id
OG000
title
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
description
Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 3 and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
id
OG001
title
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1

param Type

COUNT_OF_PARTICIPANTS

population Description

Participants that were evaluable for response.

reporting Status

POSTED

time Frame

Up to week 5

title

Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice