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The purpose of this study is to test the efficacy and safety of an experimental drug, OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal or fallopian tube cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Approximately 30 patients will be enrolled in this study at approximately 5 study centers in the United States (U.S)..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMP-305B83 plus paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMP-305B83 | Drug | intravenous (in the vein) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLT) | The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in subjects treated with OMP-305B83 in combination with Paclitaxel | Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of OMP-30B583 in combination with Paclitaxel will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis. | Through study completion, an average of 6 months | |
| To assess Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with Paclitaxel |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | United States | ||
| H. Lee Moffitt Cancer Center & Research Institute, Inc. (Moffitt Cancer Center) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35439029 | Derived | Fu S, Corr BR, Culm-Merdek K, Mockbee C, Youssoufian H, Stagg R, Naumann RW, Wenham RM, Rosengarten RD, Benjamin L, Hamilton EP, Moore KN. Phase Ib Study of Navicixizumab Plus Paclitaxel in Patients With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. J Clin Oncol. 2022 Aug 10;40(23):2568-2577. doi: 10.1200/JCO.21.01801. Epub 2022 Apr 19. |
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| Paclitaxel | Drug | administered intravenously |
|
| Through study completion, an average of 6 months |
| Response Rate assessed by RECIST criteria 1.1 | At 56 day intervals while on treatment, through study completion, an average of 6 months |
| Response Rate assessed by CA-125 criteria | At 28 day intervals while on treatment, through study completion, an average of 6 months |
| Progression Free Survival | Up to 5 years |
| Tampa |
| Florida |
| 33612 |
| United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| The University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| The University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C000657345 | navicixizumab |
| D018033 | Antibodies, Bispecific |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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