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Adavosertib Plus Chemotherapy in Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Phase 2 trial testing Adavosertib in Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation in 95 participants. Completed in 8 March 2023.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 95 |
| Start date | 30 January 2015 |
| Primary completion | 13 December 2018 |
| Estimated completion | 8 March 2023 |
| Sites | 20 locations across Netherlands, Canada, United States |
AstraZeneca — full company profile →
Adults 18 to 130, female only, with Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective response rate is defined as the proportion of patients achieving a complete or partial tumour response according to RECIST v1.1 criteria.
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 1 | |
| Arm B | 11 | |
| Arm C | 7 | |
| Arm C2 | 8 | |
| Arm D-175 mg | 2 | |
| Arm D-225 mg | 1 |
The Disease Control Rate is defined as the proportion of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1 criteria.
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 3 | |
| Arm B | 27 | |
| Arm C | 19 | |
| Arm C2 | 12 | |
| Arm D-175 mg | 3 | |
| Arm D-225 mg | 5 |
Duration of Response (DoR) is defined as the time from first documented tumour response until the date of documented progression or death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 4.4 | 0 – NA |
| Arm B | 12.0 | 3.7 – NA |
| Arm C | NA | NA – NA |
| Arm C2 | 10.4 | 5.8 – NA |
| Arm D-175 mg | NA | NA – NA |
| Arm D-225 mg | NA | NA – NA |
Progression-free survival (PFS) was defined as the elapsed time from date of first dose of AZD1775 until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. Progression-free survival was derived based on scan/assessment dates, not visit dates.
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 1.7 | 1.6 – 5.5 |
| Arm B | 5.5 | 3.8 – 7.1 |
| Arm C | 4.2 | 3.9 – 5.6 |
| Arm C2 | 12.0 | 8.6 – 13.1 |
| Arm D-175 mg | 2.7 | 1.7 – NA |
| Arm D-225 mg | NA | NA – NA |
Progression-free survival (PFS) was defined as the elapsed time from date of first dose of AZD1775 until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. Progression-free survival was derived based on scan/assessment dates, not visit dates.
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 1.7 | 0.3 – 5.5 |
| Arm B | 5.5 | 3.7 – 7.4 |
| Arm C | 4.2 | 2.8 – 8.9 |
| Arm C2 | 12.0 | 2.7 – NA |
| Arm D-175 mg | 2.7 | 0.5 – NA |
| Arm D-225 mg | NA | NA – NA |
Overall survival (OS) was defined as the elapsed time from the date of first dose of AZD1775 until death due to any cause. Any patient not known to have died at the time of the analysis was censored based on the last recorded date on which the patient was known to be alive.
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 16.0 | 6.7 – NA |
| Arm B | NA | 15.6 – NA |
| Arm C | 8.9 | 8.0 – NA |
| Arm C2 | 19.2 | 12.4 – 19.2 |
| Arm D-175 mg | 3.8 | 2.0 – 6.2 |
| Arm D-225 mg | NA | NA – NA |
Overall survival (OS) was defined as the elapsed time from the date of first dose of AZD1775 until death due to any cause. Any patient not known to have died at the time of the analysis was censored based on the last recorded date on which the patient was known to be alive.
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 16.0 | 2.2 – NA |
| Arm B | NA | 11.6 – NA |
| Arm C | 8.9 | 8.0 – NA |
| Arm C2 | 19.2 | 12.4 – 19.2 |
| Arm D-175 mg | 6.2 | 2.0 – NA |
| Arm D-225 mg | NA | NA – NA |
The GCIG CA-125 response is defined as the proportion of patients achieving a 50% reduction in CA-125 levels from baseline, if baseline level is ≥2 x the upper limit of normal (ULN) within 2 weeks prior to starting treatment. Response must be confirmed and maintained for at least 28 days.
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 25.0 | 4.6 – 60.0 |
| Arm B | 53.6 | 36.6 – 69.9 |
| Arm C | 26.7 | 9.7 – 51.1 |
| Arm C2 | 63.6 | 35.0 – 86.5 |
| Arm D-175 mg | 25.0 | 1.3 – 75.1 |
| Arm D-225 mg | 25.0 | 1.3 – 75.1 |
The number of patients experiencing at least one treatment-related adverse event (TEAE) by maximum CTCAE grade. Severity Grade 1 = Mild; Severity Grade 2 = Moderate; Severity Grade 3 = Severe; Severity Grade 4 = Life Threatening; Severity Grade 5 = Fatal
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 0 | |
| Arm B | 2 | |
| Arm C | 0 | |
| Arm C2 | 0 | |
| Arm D-175 mg | 0 | |
| Arm D-225 mg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 1 | |
| Arm B | 1 | |
| Arm C | 5 | |
| Arm C2 | 0 | |
| Arm D-175 mg | 3 | |
| Arm D-225 mg | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 2 | |
| Arm B | 19 | |
| Arm C | 10 | |
| Arm C2 | 4 | |
| Arm D-175 mg | 3 | |
| Arm D-225 mg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 6 | |
| Arm B | 15 | |
| Arm C | 8 | |
| Arm C2 | 8 | |
| Arm D-175 mg | 0 | |
| Arm D-225 mg | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 0 | |
| Arm B | 1 | |
| Arm C | 0 | |
| Arm C2 | 0 | |
| Arm D-175 mg | 0 | |
| Arm D-225 mg | 0 |
The number and proportion of patients experiencing at least one treatment-related adverse event (TEAE) related to adavosertib by maximum CTCAE grade Severity Grade 1 = Mild; Severity Grade 2 = Moderate; Severity Grade 3 = Severe; Severity Grade 4 = Life Threatening; Severity Grade 5 = Fatal
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 0 | |
| Arm B | 3 | |
| Arm C | 2 | |
| Arm C2 | 0 | |
| Arm D-175 mg | 0 | |
| Arm D-225 mg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 1 | |
| Arm B | 4 | |
| Arm C | 5 | |
| Arm C2 | 0 | |
| Arm D-175 mg | 5 | |
| Arm D-225 mg | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 3 | |
| Arm B | 16 | |
| Arm C | 7 | |
| Arm C2 | 4 | |
| Arm D-175 mg | 1 | |
| Arm D-225 mg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 5 | |
| Arm B | 14 | |
| Arm C | 8 | |
| Arm C2 | 8 | |
| Arm D-175 mg | 0 | |
| Arm D-225 mg | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 0 | |
| Arm B | 1 | |
| Arm C | 0 | |
| Arm C2 | 0 | |
| Arm D-175 mg | 0 | |
| Arm D-225 mg | 0 |
The number of patients experiencing at least one treatment-related adverse event (TEAE) related to chemotherapy by maximum CTCAE grade. Severity Grade 1 = Mild; Severity Grade 2 = Moderate; Severity Grade 3 = Severe; Severity Grade 4 = Life Threatening; Severity Grade 5 = Fatal
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 0 | |
| Arm B | 4 | |
| Arm C | 0 | |
| Arm C2 | 0 | |
| Arm D-175 mg | 0 | |
| Arm D-225 mg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 1 | |
| Arm B | 5 | |
| Arm C | 6 | |
| Arm C2 | 0 | |
| Arm D-175 mg | 5 | |
| Arm D-225 mg | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 3 | |
| Arm B | 13 | |
| Arm C | 8 | |
| Arm C2 | 4 | |
| Arm D-175 mg | 1 | |
| Arm D-225 mg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 5 | |
| Arm B | 15 | |
| Arm C | 8 | |
| Arm C2 | 8 | |
| Arm D-175 mg | 0 | |
| Arm D-225 mg | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 0 | |
| Arm B | 1 | |
| Arm C | 0 | |
| Arm C2 | 0 | |
| Arm D-175 mg | 0 | |
| Arm D-225 mg | 0 |
The number of patients experiencing at least one serious adverse event (SAE).
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 0 | |
| Arm B | 8 | |
| Arm C | 9 | |
| Arm C2 | 7 | |
| Arm D-175 mg | 1 | |
| Arm D-225 mg | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A | 0 | |
| Arm B | 8 | |
| Arm C | 9 | |
| Arm C2 | 7 | |
| Arm D-175 mg | 1 | |
| Arm D-225 mg | 1 |
Time frame: Throughout the study, approximately 19 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A | Arm B | Arm C | Arm C2 | Arm D-175 mg | Arm D-225 mg |
|---|---|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Small Intestinal Obstruction | Gastrointestinal disorders | — | — | — | — | — | — |
| Bacteraemia | Infections and infestations | — | — | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Infusion Related Reaction | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Platelet Count Decreased | Investigations | — | — | — | — | — | — |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Pancytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — | — | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — | — | — | — |
| Ileus | Gastrointestinal disorders | — | — | — | — | — | — |
| Intestinal Obstruction | Gastrointestinal disorders | — | — | — | — | — | — |
| Chest Pain | Immune system disorders | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — |
| Anaphylactic Reaction | General disorders | — | — | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — | — | — |
| Kidney Infection | Infections and infestations | — | — | — | — | — | — |
| Reaction | System | Arm A | Arm B | Arm C | Arm C2 | Arm D-175 mg | Arm D-225 mg |
|---|---|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — | — |
| Neutrophil Count Decreased | Investigations | — | — | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| White Blood Cell Count Decreased | Investigations | — | — | — | — | — | — |
| Oedema, Peripheral | General disorders | — | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Peripheral Sensory Neuropathy | Nervous system disorders | — | — | — | — | — | — |
| Platelet Count Decreased | Investigations | — | — | — | — | — | — |
| Decreased Appetite | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Urinary Tract Infection | Infections and infestations | — | — | — | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — |
| Gastrointestinal Reflux Disease | Gastrointestinal disorders | — | — | — | — | — | — |
| Aspartate Aminotransferase Increased | Investigations | — | — | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — | — | — |
| Abdominal Distension | Gastrointestinal disorders | — | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — | — | — | — |
| Alanine Aminotransferase Increased | Investigations | — | — | — | — | — | — |
| Blood Alkaline Phosphatase Increased | Investigations | — | — | — | — | — | — |
| Blood Creatinine Increased | Investigations | — | — | — | — | — | — |
Most-reported serious reactions: Thrombocytopenia, Anaemia, Febrile Neutropenia, Small Intestinal Obstruction, Bacteraemia, Neutropenia, Diarrhoea, Nausea.
Data from ClinicalTrials.gov NCT02272790 adverse events section.
Adavosertib in combination with carboplatin, paclitaxel, gemcitabine, or PLD.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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