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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005776-34 | EudraCT Number |
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The primary objective of PFS did not meet pre-specified criteria.
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This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A 2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per meter-squared (mg/m^2) IV every 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNIB0600A | Experimental | DNIB0600A will be administered on Day 1 of each cycle (1 cycle = 21 days) until significant toxicity, disease progression, or withdrawal from the study (overall up to approximately 2.5 years). |
|
| PLD | Active Comparator | PLD will be administered on Day 1 of each cycle (1 cycle = 28 days) until significant toxicity, disease progression, or withdrawal from the study (overall up to approximately 2.5 years). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNIB0600A | Drug | DNIB0600A will be administered at a dose of 2.4 mg/kg IV every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | From baseline up to disease progression or death within 30 days of last study drug administration (overall up to approximately 2.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response According to RECIST v1.1 | From baseline up to 30 days of last study drug administration (overall up to approximately 2.5 years) | |
| Duration of Objective Response | From occurrence of a documented objective response until relapse or death from any cause (overall up to approximately 2.5 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph'S Hospital & Medical Center | Phoenix | Arizona | 85013 | United States | ||
| HonorHealth Research Institute - Pima Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407274 | Derived | Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3. | |
| 29401246 | Derived | Banerjee S, Oza AM, Birrer MJ, Hamilton EP, Hasan J, Leary A, Moore KN, Mackowiak-Matejczyk B, Pikiel J, Ray-Coquard I, Trask P, Lin K, Schuth E, Vaze A, Choi Y, Marsters JC, Maslyar DJ, Lemahieu V, Wang Y, Humke EW, Liu JF. Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study. Ann Oncol. 2018 Apr 1;29(4):917-923. doi: 10.1093/annonc/mdy023. |
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| PLD | Drug | PLD will be administered at a dose of 40 mg/m^2 IV every 4 weeks. |
|
| Overall Survival (OS) | From baseline up to death from any cause (overall up to approximately 2.5 years) |
| Percentage of Participants With Adverse Events (AEs) | From baseline up to 30 days of last study drug administration (overall up to approximately 2.5 years) |
| Area Under the Concentration-time Curve (AUC) of DNIB0600A | Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4 |
| Maximum Concentration (Cmax) of DNIB0600A | Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4 |
| Clearance (CL) of DNIB0600A | Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4 |
| Elimination Half-life (t1/2) of DNIB0600A | Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4 |
| Volume of Distribution at Steady State (Vss) of DNIB0600A | Pre-DNIB0600A infusion, 30 minutes post infusion (infusion length=90 minutes) on Day 1 of each Cycle (1cycle=21 days) (overall up to approximately 2.5 years); Day 8 of Cycle 1; Day 15 of Cycles 1-4 |
| Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against DNIB0600A | Pre-DNIB0600A infusion on Day 1 of Cycles 1-4 (1cycle=21 days), at approximately 15-30 days after last infusion administration (overall up to approximately 2.5 years) |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
| Florida Cancer Specialists. | St. Petersburg | Florida | 33705 | United States |
| Hematology & Oncology Associates | Covington | Louisiana | 70433 | United States |
| Johns Hopkins Uni; Oncology Center | Baltimore | Maryland | 21231 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Oklahoma University Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Northwest Cancer Specialists, P.C. | Tualatin | Oregon | 97062 | United States |
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Women & Infants Hospital | Providence | Rhode Island | 02905 | United States |
| Sarah Cannon Cancer Center | Germantown | Tennessee | 38138 | United States |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M4X 1K9 | Canada |
| Chum Hopital Notre Dame; Centre D'Oncologie | Montreal | Quebec | H2L 4M1 | Canada |
| Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes | Lyon | 69008 | France |
| Hôpital Européen Georges Pompidou | Paris | 75908 | France |
| HOPITAL TENON; Cancerologie Medicale | Paris | 75970 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Bialostockie Centrum Onkologi | Bialystok | 15-027 | Poland |
| Wojewodzkie Centrum Onkologii | Gdansk | 80-219 | Poland |
| Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON | Warsaw | 04-141 | Poland |
| Hospital Universitario Vall d'Hebron; Servicio de Neumologia | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia | Madrid | 28050 | Spain |
| Sarah Cannon Research Institute | London | W1G 6AD | United Kingdom |
| Christie Hospital | Manchester | M20 3BG | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Metropolitan Borough of Wirral | L63 4JY | United Kingdom |
| The Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Royal Marsden NHS Foundation Trust | Sutton, Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian 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 |
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| ID | Term |
|---|---|
| C000654806 | lifastuzumab vedotin |
| C041277 | 1-dodecylpyridoxal |
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