Clinical trial · Interventional
[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer
Phase 1b Exploratory Study of [18F]Fluciclatide-PET as a Marker of Angiogenic Response to Combination Therapy With the Pan-VEGF Inhibitor, Pazopanib, and Weekly Paclitaxel in Platinum Resistant Ovarian Cancer
NCT01608009CI-TRIAL-00026383PAZPET-1completedPhase 1ClinicalTrials.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 this study is to assess \[18F\] -fluciclatide as a biomarker of response to pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel in platinum-resistant ovarian cancer patients.
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 Neoplasm | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pazopanib and paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pazopanib and paclitaxel
- interventionNames
- Drug: Pazopanib and paclitaxel
Primary outcomes (1)
- measure
- Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment
- timeFrame
- 1 week
- description
- Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant
Secondary outcomes (2)
- measure
- The proportion of women who experience side effects from the combination of paclitaxel and pazopanib
- timeFrame
- 12 months
- description
- Core study assessments including physical examination, vital signs, ECG, and adverse event reporting
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of relapsed ovarian cancer * Responded to at least on one line of prior platinum based therapy * Relapsed within platinum resistant interval (≤6months) * Eastern Cooperative Oncology Group (ECOG) performance status of \<2 * Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques * Satisfactory baseline haematologic and organ function: * Haematologic: Absolute neutrophil count \> or = 1.5 X 10\^9/L; Platelets \> or = 100 X 10\^9/L; Haemoglobin \> or = 9g/dL; PT or INR \< or = 1.2 x ULN; PTT \< or = 1.2 x ULN * Hepatic: Bilirubin \< or = 1.5 X ULN; AST or ALT \< or = 2.5 X ULN * Renal: Serum creatinine \< or = 1.5 mg/dL; Or if \>1.5 mg/dL, calculated creatinine clearance \> or = 50mL/min; UPC \<1 Exclusion Criteria: * Poorly controlled hypertension \[defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg\]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be \<140/90 mmHg in order for a subject to be eligible for the study. * Treatment with any of the following anti-cancer therapies: * radiation therapy 28 days prior to the first dose of pazopanib OR * surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR * chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib * Treatment with anti-angiogenic therapy * Presence of gross ascites * Clinically significant peripheral neuropathy * Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study
References
Publications (0)
Data not yet available
No reference posted for this study.