Fallopian Tube Cancer Clinical Trial
Official title:
A Phase II Randomized Open Label Study of MM-121 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Platinum Resistant/ Refractory Advanced Ovarian Cancers
| Verified date | June 2013 |
| Source | Merrimack Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone
| Status | Active, not recruiting |
| Enrollment | 210 |
| Est. completion date | April 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer - Received at least one prior platinum based chemotherapy regimen - Platinum-resistant or refractory - Eligible for weekly paclitaxel - Adequate liver and kidney function - 18 years of age or above Exclusion Criteria: - Evidence of any other active malignancy - History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | Carolinas Medical Center/Blumenthal Cancer Center | Charlotte | North Carolina |
| United States | Chattanooga GYN Oncology | Chattanooga | Tennessee |
| United States | Wilshire Oncology Medical Group | Corona | California |
| United States | Arizona Center for Cancer Care | Glendale | Arizona |
| United States | Indiana University Simon Cancer Center | Indianapolis | Indiana |
| United States | North County Oncology | Oceanside | California |
| United States | Central Coast Medical Oncology | Santa Maria | California |
| United States | Pinnacle Oncology | Scottsdale | Arizona |
| United States | ProMedica Health System, Inc. | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Merrimack Pharmaceuticals | Sanofi |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival | 38 months | No |
| 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 |
NCT03480750 -
Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01610206 -
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
|
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 |