A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ovarian Cancer (PROC)

NCT ID: NCT01991210

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-06
• Study Completion Date: 2016-08-17

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DNIB0600A

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).

Group Type: EXPERIMENTAL

DNIB0600A

Intervention Type: DRUG

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

PLD

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).

Group Type: ACTIVE_COMPARATOR

PLD

Intervention Type: DRUG

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

Interventions

DNIB0600A

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

Intervention Type: DRUG

PLD

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

Intervention Type: DRUG

Other Intervention Names

RO5541081

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Pregnancy or breastfeeding
• Known history of NaPi2b deficiency (for example, congenital alveolar microlithiasis or testicular microlithiasis)
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
• Metabolic dysfunction, physical examination finding, or clinical laboratory find giving reasonable suspicion of a disease or condition that contraindicated use of an investigational drug or may render the participant at high risk from treatment complications

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

St. Joseph'S Hospital & Medical Center

Phoenix, Arizona, United States

HonorHealth Research Institute - Pima Center

Scottsdale, Arizona, United States

University of California Irvine Medical Center

Orange, California, United States

Florida Cancer Specialists.

St. Petersburg, Florida, United States

Hematology & Oncology Associates

Covington, Louisiana, United States

Johns Hopkins Uni; Oncology Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Inst.

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, United States

Northwest Cancer Specialists, P.C.

Tualatin, Oregon, United States

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Women & Infants Hospital

Providence, Rhode Island, United States

Sarah Cannon Cancer Center

Germantown, Tennessee, United States

UZ Leuven Gasthuisberg

Leuven, , Belgium

CHU Sart-Tilman

Liège, , Belgium

London Regional Cancer Centre

London, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Chum Hopital Notre Dame; Centre D'Oncologie

Montreal, Quebec, Canada

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

Lyon, , France

Hôpital Européen Georges Pompidou

Paris, , France

HOPITAL TENON; Cancerologie Medicale

Paris, , France

Institut Gustave Roussy

Villejuif, , France

Bialostockie Centrum Onkologi

Bialystok, , Poland

Wojewodzkie Centrum Onkologii

Gdansk, , Poland

Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

Warsaw, , Poland

Hospital Universitario Vall d'Hebron; Servicio de Neumologia

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

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

Madrid, , Spain

Sarah Cannon Research Institute

London, , United Kingdom

Christie Hospital

Manchester, , United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, , United Kingdom

The Royal Marsden Hospital

Sutton, , United Kingdom

Royal Marsden NHS Foundation Trust

Sutton, Surrey, , United Kingdom

Countries

United States; Belgium; Canada; France; Poland; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37407274 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29401246 (View on PubMed)

Other Identifiers

2012-005776-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO28609

Identifier Type: -

Identifier Source: org_study_id