Ovarian Cancer Recurrent Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer
This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).
This is a multicenter, randomized, double-blind, Phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers). Approximately 168 subjects will be enrolled into the study. Eligible subjects will be randomized in a 2: 1 ratio to receive IN10018 in combination with PLD treatment (Experimental Arm, N = approx. 112) or placebo of IN10018 in combination with PLD (Control Arm, N = approx. 56). Subjects will be stratified by prior bevacizumab use (yes or no) and platinum free interval (PFI, < 3 months or 3-6 months). Subjects will be randomized to one of following treatment arms. The investigator should follow the clinical study protocol, the approved label of these drugs and/or institutional standard of care. - Experimental Arm: IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV). - Control Arm: Placebo of IN10018 100 mg QD orally (PO) plus PLD 40 mg/m2 once every 4 weeks (Q4W) intravenously (IV). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05001282 -
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03717610 -
Hyperthermic Intraperitoneal Chemotherapy for Treatment of Relapsed Ovarian Cancer
|
N/A | |
| Recruiting |
NCT04175470 -
Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer
|
Phase 2 | |
| Recruiting |
NCT03983226 -
Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
|
Phase 2 | |
| Recruiting |
NCT05095558 -
Microtransplantation for Ovarian Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03657966 -
DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06102707 -
The Efficacy and Safety of Fluzopril Combined With Apatinib in Maintenance Treatment of Platinum Resistant Recurrent Ovarian Cancer Patients
|
N/A | |
| Terminated |
NCT03162562 -
The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer
|
Phase 1 | |
| Withdrawn |
NCT04149145 -
Trial of M4344 and Niraparib in Patients With Poly (ADP-ribose) Polymerase (PARP) Resistant Recurrent Ovarian Cancer
|
Phase 1 | |
| Completed |
NCT01332656 -
Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel
|
Phase 2 | |
| Completed |
NCT01111903 -
A 2 Stage Trial of Lenalidomide (REV) in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03734692 -
Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03827837 -
Famitinib Plus Anti-PD1 Therapy for Advanced Urinary System Tumor, Advanced Gynecological Tumors
|
Phase 2 | |
| Not yet recruiting |
NCT05990192 -
SBRT Alone or Followed by Niraparib for Oligometastases or Oligoprogression in Ovarian Cancer Following PARPi Therapy
|
Phase 2 | |
| Completed |
NCT01485848 -
EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT03681548 -
A Study of Doxorubicin Hydrochloride Liposome Injection in Subjects With Ovarian Cancer.
|
Phase 1 | |
| Recruiting |
NCT04072263 -
Adoptive T Cell Therapy in Patients With Recurrent Ovarian Cancer
|
Phase 1/Phase 2 |