NCT01991210

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
Completed

Started Feb 2014

Geographic Reach
7 countries

36 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2016

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

2.5 years

First QC Date

November 15, 2013

Last Update Submit

August 17, 2017

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (10)

  • 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)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

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).

Drug: DNIB0600A

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).

Drug: PLD

Interventions

DNIB0600ADRUG

DNIB0600A will be administered at a dose of 2.4 mg/kg IV every 3 weeks.

Also known as: RO5541081
DNIB0600A
PLDDRUG

PLD will be administered at a dose of 40 mg/m\^2 IV every 4 weeks.

PLD

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
  • Advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months after the most recent treatment with a platinum-containing chemotherapy regimen and for whom PLD is appropriate therapy
  • No more than 1 prior cytotoxic chemotherapy regimens for the treatment of PROC and not more than 2 total regimens (defined as any therapy \[approved or investigational\] with intent to treat the ovarian cancer)
  • Adequate hematologic, renal and liver function
  • Willing and able to perform a patient-reported outcome (PRO) survey (including the possibility of using an electronic PRO device)
  • For women of childbearing potential, agreement to use 1 highly effective form of contraception as defined by protocol through the course of study treatment and for 6 months after the last dose of study treatment

You may not qualify if:

  • Primary platinum-refractory disease defined as disease progression during or within 2 months of a first-line, platinum-containing chemotherapy regimen
  • Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, within 4 weeks prior to Day 1
  • Palliative radiation within 2 weeks prior to Day 1
  • Prior anthracycline therapy, including prior treatment with PLD (for example, Doxil®, Caelyx®, or Lipodox®) in any setting (for example, in combination with carboplatin or as a single agent)
  • Prior treatment with NaPi2b or SCL34A2 targeted therapy
  • Major surgical procedure within 4 weeks prior to Day 1
  • Current Grade greater than (\>) 1 toxicity (except alopecia and anorexia) from prior therapy or Grade \>1 neuropathy from any cause
  • Left ventricular ejection fraction defined by multigated acquisition (MUGA)/echocardiogram below the institutional lower limit of normal
  • Evidence of significant, uncontrolled, concomitant disease that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or significant pulmonary disease
  • Known active infection, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (within 4 weeks prior to Cycle 1, Day 1)
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Presence of positive test results for hepatitis B or hepatitis C as detailed in the protocol
  • Known history of HIV seropositive status
  • Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, adequately controlled limited basal cell skin cancer, or synchronous primary endometrial cancer or prior primary endometrial cancer
  • Untreated or active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

St. Joseph'S Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

HonorHealth Research Institute - Pima Center

Scottsdale, Arizona, 85258, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Florida Cancer Specialists.

St. Petersburg, Florida, 33705, United States

Location

Hematology & Oncology Associates

Covington, Louisiana, 70433, United States

Location

Johns Hopkins Uni; Oncology Center

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Inst.

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Northwest Cancer Specialists, P.C.

Tualatin, Oregon, 97062, United States

Location

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Sarah Cannon Cancer Center

Germantown, Tennessee, 38138, United States

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

CHU Sart-Tilman

Liège, 4000, Belgium

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M4X 1K9, Canada

Location

Chum Hopital Notre Dame; Centre D'Oncologie

Montreal, Quebec, H2L 4M1, Canada

Location

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

Lyon, 69008, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

HOPITAL TENON; Cancerologie Medicale

Paris, 75970, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Bialostockie Centrum Onkologi

Bialystok, 15-027, Poland

Location

Wojewodzkie Centrum Onkologii

Gdansk, 80-219, Poland

Location

Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

Warsaw, 04-141, Poland

Location

Hospital Universitario Vall d'Hebron; Servicio de Neumologia

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

Madrid, 28050, Spain

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

Christie Hospital

Manchester, M20 3BG, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, L63 4JY, United Kingdom

Location

The Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 37407274DERIVED

  • 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.

    PMID: 29401246DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

lifastuzumab vedotin1-dodecylpyridoxal

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 25, 2013

Study Start

February 6, 2014

Primary Completion

August 17, 2016

Study Completion

August 17, 2016

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations

PL(3)BE(2)CA(3)FR(4)GB(5)ES(5)US(14)