Trial · NCT03345784
Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers
NCT03345784, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2023-06-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers. Trials, record NCT03345784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03345784
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers
- NCT number
- NCT03345784
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Cervical Carcinoma, Endometrioid Adenocarcinoma, Malignant Female Reproductive System Neoplasm, Recurrent Cervical Carcinoma, Stage I Uterine Corpus Cancer AJCC v7, Stage I Vaginal Cancer AJCC v6 and v7, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Cervical Cancer AJCC v6 and v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage IB2 Cervical Cancer AJCC v6 and v7, Stage II Cervical Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7, Stage II Vaginal Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage III Cervical Cancer AJCC v6 and v7, Stage III Uterine Corpus Cancer AJCC v7, Stage III Vaginal Cancer AJCC v6 and v7, Stage IIIA Cervical Cancer AJCC v6 and v7, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IIIB Uterine Corpus Cancer AJCC v7, Stage IIIC Uterine Corpus Cancer AJCC v7, Vaginal Carcinoma
- Interventions
- Adavosertib, Cisplatin, External Beam Radiation Therapy
- First posted
- 2017-11-17
- Last updated
- 2024-02-20
- Results first posted
- 2023-06-06
- Limitations and caveats
- The main limitation of our study is the small number of patients enrolled due to premature closure; yet the study showed the limiting toxicities of this triplet combination.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities | Up to week 5 | 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. |
| Secondary | Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Up to 2 years | 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. |
| Secondary | Pharmacodynamic Effects of AZD1775 in Combination With RT and Concurrent Cisplatin | Up to 2 years | 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. |
| Secondary | Progression-free Survival | From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years | 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 ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities | Up to week 5 | Participants that were evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Up to 2 years | events | NUMBER | |
| SECONDARY | Pharmacodynamic Effects of AZD1775 in Combination With RT and Concurrent Cisplatin | Up to 2 years | Not analyzed as samples were not collected, therefore no data are available. | ||
| SECONDARY | Progression-free Survival | From start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | NA | Participants | ||
| Recommended Phase 2 Dose Defined as the Dose Level With < 1/6 Patients With Dose Limiting Toxicities | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | NA | Participants | ||
| Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | All Grade 1-2 Toxicities | 46 | events | |
| Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | All Grade 1-2 Toxicities | 53 | events | |
| Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Related Grade 1-2 Toxicities | 37 | events | |
| Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Related Grade 1-2 Toxicities | 36 | events | |
| Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | All Grade 3-4 Toxicities | 8 | events | |
| Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | All Grade 3-4 Toxicities | 3 | events | |
| Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | Related Grade 3-4 Toxicities | 8 | events | |
| Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | Related Grade 3-4 Toxicities | 3 | events |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 5 | |
| Overall Study | STARTED | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 5 | |
| Overall Study | COMPLETED | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 3 | |
| Overall Study | COMPLETED | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 4 | |
| Overall Study | NOT COMPLETED | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 2 | |
| Overall Study | NOT COMPLETED | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 1 |
Source ClinicalTrials.gov
Adverse events114
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 4 | 4 | 5 |
| other | Nausea | Gastrointestinal disorders | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 5 | 5 | 7 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 3 | 4 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 4 | 5 | 4 |
| other | Fatigue | General disorders | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 3 | 4 | 3 |
| other | Fatigue | General disorders | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 3 | 5 | 4 |
| other | Hypomagnesemia | Metabolism and nutrition disorders | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 3 | 4 | 3 |
| other | Hypomagnesemia | Metabolism and nutrition disorders | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 0 | 5 | 0 |
| other | Thrombocytopenia | Investigations | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 3 | 4 | 6 |
| other | Thrombocytopenia | Investigations | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 0 | 5 | 0 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 0 | 4 |
| Total, all-cause mortality | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 0 | 5 |
| Total, other adverse events | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 4 | 4 |
| Total, other adverse events | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 5 | 5 |
| Total, serious adverse events | Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 1 | 4 |
| Total, serious adverse events | Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 1 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186644 | North American Star Consortium | BEDARD, PHILIPPE; COURTNEY, KEVIN D; GRANT, STEVEN; LANCET, JEFFREY; MAHALINGAM, DEVALINGAM; SIU, LILLIAN L | UNIVERSITY HEALTH NETWORK | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 vs Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1: deaths from any cause | Trial comparisons |
| Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 vs Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03345784
GET https://conductscience.org/api/trials/v1/NCT03345784/events?page=2