NCT03345784 · STUDY IN CONTEXT

Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Participants that were evaluable for response.

→

secondary · POSTED

To determine the acute and late toxicity of AZD1775 when administered to patients with gynecological cancer in combination with standard radiotherapy and concurrent cisplatin. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a subanalysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to one or both study treatments.

Source null

→

secondary · POSTED

To evaluate the pharmacodynamic effects of AZD1775 drugs when administered in combination with radiotherapy and concurrent cisplatin. Pharmacodynamic biomarkers will include: pCDC2, Ki67, γH2AX, pH3, and CC3. Associations between pharmacokinetic data with toxicity profiles will be performed primarily using descriptive statistics; however, logistic regression may be used if warranted.

Not analyzed as samples were not collected, therefore no data are available.

→

secondary · POSTED

To obtain preliminary information about the progression-free survival of AZD1775 in combination with radiotherapy and concurrent cisplatin in women with locally advanced gynecological cancer. Progression is defined a clinical or radiological using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-vaginal-cancer
nct id: NCT03345784
trial label: Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0000
source section id
NCT03345784-om-0000
source outcome index
0
endpoint
Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities
endpoint definition
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.
time origin
Up to week 5
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants that were evaluable for response.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0001
source section id
NCT03345784-om-0001
source outcome index
1
endpoint
Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin
endpoint definition
To determine the acute and late toxicity of AZD1775 when administered to patients with gynecological cancer in combination with standard radiotherapy and concurrent cisplatin. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a subanalysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to one or both study treatments.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0002
source section id
NCT03345784-om-0002
source outcome index
2
endpoint
Pharmacodynamic Effects of AZD1775 in Combination With RT and Concurrent Cisplatin
endpoint definition
To evaluate the pharmacodynamic effects of AZD1775 drugs when administered in combination with radiotherapy and concurrent cisplatin. Pharmacodynamic biomarkers will include: pCDC2, Ki67, γH2AX, pH3, and CC3. Associations between pharmacokinetic data with toxicity profiles will be performed primarily using descriptive statistics; however, logistic regression may be used if warranted.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Not analyzed as samples were not collected, therefore no data are available.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0003
source section id
NCT03345784-om-0003
source outcome index
3
endpoint
Progression-free Survival
endpoint definition
To obtain preliminary information about the progression-free survival of AZD1775 in combination with radiotherapy and concurrent cisplatin in women with locally advanced gynecological cancer. Progression is defined a clinical or radiological using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.
time origin
From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0000
arm key
OG000
arm label
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345784-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0000
arm key
OG001
arm label
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
regimen
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.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345784-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0001
arm key
OG000
arm label
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
regimen
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.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345784-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0001
arm key
OG001
arm label
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
regimen
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.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345784-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0002
arm key
OG000
arm label
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
regimen
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.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345784-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0002
arm key
OG001
arm label
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
regimen
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.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345784-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0003
arm key
OG000
arm label
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345784-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
outcome key
om-0003
arm key
OG001
arm label
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
regimen
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.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345784-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
harm key
EG000
source section id
NCT03345784-ae
event group key
EG000
event group label
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
2 years
event definition
Through regular investigator assessment, regular laboratory testing, etc. Frequency and severity of adverse events were tabulated using counts and proportions.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-vaginal-cancer
nct id
NCT03345784
harm key
EG001
source section id
NCT03345784-ae
event group key
EG001
event group label
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
serious affected
1
serious at risk
5
other affected
5
other at risk
5
frequency threshold
0
collection period
2 years
event definition
Through regular investigator assessment, regular laboratory testing, etc. Frequency and severity of adverse events were tabulated using counts and proportions.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice