ENGOT – ov16/NOVA
A Phase 3 Randomized Double-blind Trial of Maintenance with Niraparib versus Placebo in Patients with Platinum Sensitive Ovarian Cancer
This main study is a double-blind, 2:1 randomized, placebo controlled study in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology. The patients must have received at least two platinum-based regimens, had a response to their last regimen, and have no measurable disease >2cm, and normal CA125 (or >90% decrease) following their last treatment. The study will assess whether maintenance with niraparib will extend PFS in this population. There will be 2 independent patient cohorts, one with deleterious gBRCAmut and the other with high-grade serous histology but without such gBRCA mutations based on the hypothesis that patients with gBRCA mutations will be enriched for responsiveness to niraparib.
ENGOT – ov20/DESKTOP III
Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operation. The goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.
OVAR17 / BOOST
A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer.
The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.
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 Ephitelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
In this study, patients with relapsed or refractory ovarian cancer will receive treatment with pazopanib and liposomal doxorubicin (Doxil) until disease progression or unacceptable toxicity occurs. The Phase I portion will define the dose limiting toxicity (DLT) of pazopanib and liposomal doxorubicin when administered in combination. Once the maximum tolerated dose has been identified in the Phase I portion, the Phase II portion will evaluate efficacy and safety of this combination in the same patient population.
ENGOT – ov14/PENELOPE
A two-part, randomized phase ii, double-blind, multicenter trial assessing the efficacy and safety of pertuzumabin combination with standard chemotherapy vs. Placebo plus standard chemotherapy in women with recurrent platium resistant epithelial ovarian cancer and low her3 mrna expression.
This two-part, multicenter study will evaluate the safety and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelian ovarian cancer. In the non-randomized Part 1 safety run-in, patients will receive pertuzumab (840 mg iv loading dose followed by 420 mg every 3 weeks) plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, patients will receive either pertuzumab (840 mg iv loading dose followed by 420 mg every 3 weeks) or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer.
The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.
ENGOT – ov2/Trinova-3
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer.
This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10mg/kg iv 2-weekly or 15mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15mg/kg iv 3-weekly). Target sample size is 100-500 individuals.