Clinical trial · Interventional
Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer
A Phase II Study of Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer
NCT03924882CI-TRIAL-00038298unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to three years
- description
- Objective response rate defined as confirmed complete response or partial response under RECIST 1.1 criteria. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
Secondary outcomes (3)
- measure
- Progression-free survival (PFS)
- timeFrame
- Up to three years
- measure
- Duration of Response
- timeFrame
- Up to three years
- measure
- Frequency and severity of adverse effects as defined by CTCAE version 4.03
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, age ≥18 years and ≤70 years, signed informed consent. 2. Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary. 3. Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy) 4. At least treated with one line of platinum-based chemotherapy 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version or CA125 7. Patients must have a life expectancy of at least 3 months. 8. Patients must have adequate organ function. Exclusion Criteria: 1. Had prior exposure to anlotinib or has known allegies to any of the excipients, Inadequately controlled hypertension 2. History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1. 3. History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1 4. Major surgical procedure within 28 days prior to Day 1, Serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to Day 1 5. Symptomatic central nervous system (CNS) metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.