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Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium
Phase 2 trial testing Rucaparib in Cervical Cancer in 49 participants. Completed in 29 September 2023.
| Lead sponsor | University of Oklahoma |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 29 June 2018 |
| Primary completion | 12 May 2020 |
| Estimated completion | 29 September 2023 |
| Sites | 3 locations across United States |
University of Oklahoma
Adults 18 to 99, female only, with Cervical Cancer or Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To estimate the proportion of pts treated w/bevacizumab who are progression-free. Progression for measurable disease per RECIST v1.1. Progression for pts with non-measurable disease at baseline is defined as increasing clinical, radiological, or histological evidence of disease since study entry.
| Group | Value | 95% CI |
|---|---|---|
| Bevacizumab + Rucaparib | 0.29 | 0.13 – 0.47 |
To estimate the proportion of patients treated with bevacizumab and rucaparib who have objective tumor response (complete or partial)
| Group | Value | 95% CI |
|---|---|---|
| Bevacizumab + Rucaparib | 0.14 | 0.04 – 0.33 |
To determine the nature and degree of toxicity in combination of rucaparib and bevacizumab (Adverse Event Grade 3 and higher).
| Group | Value | 95% CI |
|---|---|---|
| Bevacizumab + Rucaparib | 22 |
To estimate the median overall survival of patients treated with combination rucaparib and bevacizumab.
| Group | Value | 95% CI |
|---|---|---|
| Bevacizumab + Rucaparib | 10.12 | 7.04 – 15.17 |
To estimate the progression-free survival (PFS) of patients with persistent or recurrent cervical or endometrial cancer treated with combination rucaparib and bevacizumab Progression for measurable disease per RECIST v1.1 Progression for patients with non-measurable disease at baseline is defined as increasing clinical, radiological, or histological evidence of disease since study entry.
| Group | Value | 95% CI |
|---|---|---|
| Bevacizumab + Rucaparib | 3.83 | 2.51 – 5.72 |
Time frame: up to 34 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Bevacizumab + Rucaparib |
|---|---|---|
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Sepsis | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Bevacizumab + Rucaparib |
|---|---|---|
| Nausea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Hypertension | Vascular disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Dizziness | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Proteinuria | Renal and urinary disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Localized edema | General disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Platelet count decreased | Investigations | — |
| Weight loss | Investigations | — |
| Agitation | Psychiatric disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Creatinine increased | Investigations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Pain | General disorders | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Hot flashes | Vascular disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Anxiety | Psychiatric disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Urinary frequency | Renal and urinary disorders | — |
| Blurred vision | Eye disorders | — |
Most-reported serious reactions: Nausea, Vomiting, Acute kidney injury, Abdominal pain, Fatigue, Sepsis, Urinary tract infection, Dyspnea.
Data from ClinicalTrials.gov NCT03476798 adverse events section.
This is a phase II study of rucaparib, a small molecule inhibitor poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP), being tested in combination with bevacizumab in patients with recurrent cervical or endometrial cancer. The objective of this study is to determine the proportion of these patients who survive progression-free for at least 6 months while receiving this drug combination.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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