Clinical trial · Interventional
Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- 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)
This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pazopanib | Drug | Pazopanib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- matched placebo tablet administered orally once daily for up to 24 months
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Pazopanib
- description
- Pazopanib tablet administered orally at 800 mg once daily for up to 24 months
- interventionNames
- Drug: Pazopanib
Primary outcomes (1)
- measure
- Investigator-assessed Progression-free Survival (PFS)
- timeFrame
- From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * written informed consent * At least 18 years old. * Histologically confirmed, FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy. * Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved. * No evidence of disease progression * ECOG status of 0 or 2 * Able to swallow and retain oral medication. * Adequate hematologic, hepatic, and renal system function as follows: Hematologic * Absolute neutrophil count (ANC) at least 1.5 X 10\^9/L * Hemoglobin at least 9 g/dL (or 5.59 mmol/L) * Platelets at least 100 X 10\^9/L * Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN * Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic * Total bilirubin up to 1.5 X ULN * AST and ALT up to 2.5 X ULN Renal * Serum creatinine up to 1.5 mg/dL Or, if greater than 1.5 mg/dL: Calculated creatinine clearance at least 50 mL/min Urine Protein * Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or \< 1.0 gram determined by 24- hour urine protein analysis. * Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception. Exclusion Criteria: * Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy * Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met. * Clinically significant gastrointestinal abnormalities * Prolongation of corrected QT interval (QTc) \> 480 msecs * History of any one or more cardiovascular conditions within the past 6 months prior to randomization * Cardiac angioplasty or stenting * Myocardial infarction * Unstable angina * Symptomatic peripheral vascular disease * Class III or IV congestive heart failure * Poorly controlled hypertension * History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization * Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer. * Evidence of active bleeding or bleeding diathesis. * Hemoptysis within 6 weeks prior to randomization. * Endobronchial metastases. * Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. * Investigational or anti-VEGF anticancer therapy prior to study randomization. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib * Invasive malignancies that showed activity of disease within 5 years prior to randomization
References
Publications (7)
- DERIVEDGaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. PMID 37185961
- DERIVEDVergote I, du Bois A, Floquet A, Rau J, Kim JW, Del Campo JM, Friedlander M, Pignata S, Fujiwara K, Colombo N, Mirza MR, Monk BJ, Tsibulak I, Calvert PM, Herzog TJ, Hanker LC, Meunier J, Lee JY, Bologna A, Carrasco-Alfonso MJ, Harter P. Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer. Gynecol Oncol. 2019 Nov;155(2):186-191. doi: 10.1016/j.ygyno.2019.08.024. Epub 2019 Sep 10. PMID 31519320
- DERIVEDFriedlander M, Rau J, Lee CK, Meier W, Lesoin A, Kim JW, Poveda A, Buck M, Scambia G, Shimada M, Hilpert F, King MT, Debruyne P, Bologna A, Malander S, Monk BJ, Petru E, Calvert P, Herzog TJ, Barrett C, du Bois A. Quality of life in patients with advanced epithelial ovarian cancer (EOC) randomized to maintenance pazopanib or placebo after first-line chemotherapy in the AGO-OVAR 16 trial. Measuring what matters-patient-centered end points in trials of maintenance therapy. Ann Oncol. 2018 Mar 1;29(3):737-743. doi: 10.1093/annonc/mdx796. PMID 29267856
- DERIVEDPulford DJ, Harter P, Floquet A, Barrett C, Suh DH, Friedlander M, Arranz JA, Hasegawa K, Tada H, Vuylsteke P, Mirza MR, Donadello N, Scambia G, Johnson T, Cox C, Chan JK, Imhof M, Herzog TJ, Calvert P, Wimberger P, Berton-Rigaud D, Lim MC, Elser G, Xu CF, du Bois A. Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study. BMC Med Ethics. 2016 Oct 21;17(1):63. doi: 10.1186/s12910-016-0144-y. PMID 27769273
- DERIVEDKim JW, Mahner S, Wu LY, Shoji T, Kim BG, Zhu JQ, Takano T, Park SY, Kong BH, Wu Q, Wang KL, Ngan HY, Liu JH, Wei LH, Mitrica I, Zhang P, Crescenzo R, Wang Q, Cox CJ, Harter P, du Bois A. Pazopanib Maintenance Therapy in East Asian Women With Advanced Epithelial Ovarian Cancer: Results From AGO-OVAR16 and an East Asian Study. Int J Gynecol Cancer. 2018 Jan;28(1):2-10. doi: 10.1097/IGC.0000000000000602.