Fallopian Tube Cancer Clinical Trial
Official title:
A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects With Advanced High Grade Serous Ovarian Cancer
This is a randomized, phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of sovilnesib at different dose levels to establish the Recommended Phase 2 Dose (RP2D) of sovilnesib in subjects with high grade serous ovarian cancer (HGSOC).
This is a randomized, phase 1b dose optimization study of sovilnesib in subjects with platinum-resistant HGSOC. The focus of the proposed clinical study is to establish the RP2D of sovilnesib in HGSOC. An adaptive multi-cohort design will be used to assess the safety, tolerability, PK, and efficacy of multiple dose levels in parallel to establish the RP2D of sovilnesib. The study will be conducted in 2 parts. Part 1: 10 subjects will be randomized to each of the open dose levels to generate preliminary PK, pharmacodynamic (PD), safety, tolerability and efficacy data. Early stopping rules for safety based on a Bayesian Toxicity Monitoring Design will be applied. Part 2: Based on review of the data from Part 1, 20-30 additional subjects will be randomized to 2 or more dose levels examined in Part 1. At the end of Part 2, PK, PD, safety, tolerability and efficacy data will be used to determine the RP2D. Early stopping rules for safety based on a Bayesian Toxicity Monitoring Design and for futility based on a Bayesian Efficacy Monitoring via Predictive Probability Design will be applied. Sovilnesib will be given orally in 28-day cycles at selected dose levels of interest. Dosing will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03393884 -
Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)
|
Phase 1/Phase 2 | |
Completed |
NCT04546373 -
Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
|
||
Active, not recruiting |
NCT05456685 -
IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer
|
Phase 2 | |
Completed |
NCT01442051 -
Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
|
N/A | |
Completed |
NCT02928549 -
Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
|
||
Active, not recruiting |
NCT03648489 -
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)
|
Phase 2 | |
Not yet recruiting |
NCT04983550 -
Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC
|
Phase 2 | |
Completed |
NCT02480374 -
Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer
|
Phase 1 | |
Completed |
NCT01899599 -
PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
|
Phase 2 | |
Completed |
NCT01610206 -
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
|
Phase 2 | |
Completed |
NCT03480750 -
Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01219777 -
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
|
Phase 1 | |
Completed |
NCT01031381 -
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
|
Phase 2 | |
Completed |
NCT00959582 -
Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)
|
Phase 1 | |
Suspended |
NCT00753480 -
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 1 | |
Completed |
NCT00768144 -
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
|
Phase 2 | |
Completed |
NCT00801320 -
Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer
|
N/A | |
Completed |
NCT00702299 -
Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer
|
Phase 1 | |
Recruiting |
NCT02349958 -
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy
|
Phase 2 | |
Terminated |
NCT00418093 -
Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
|
Phase 2 |