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

Ovarian Cancer Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DNIB0600A Compared to Pegylated Liposomal Doxorubicin Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01991210
• Other study ID #: GO28609
• Secondary ID: 2012-005776-34
• Status: Terminated
• Phase: Phase 2
• First received: November 15, 2013
• Last updated: August 17, 2017
• Start date: February 6, 2014
• Est. completion date: August 17, 2016

Study information

• Verified date: August 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: August 17, 2016
• Est. primary completion date: August 17, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• DNIB0600A
DNIB0600A will be administered at a dose of 2.4 mg/kg IV every 3 weeks.
• PLD
PLD will be administered at a dose of 40 mg/m^2 IV every 4 weeks.

Locations

Country	Name	City	State
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHU Sart-Tilman	Liège
Canada	London Regional Cancer Centre	London	Ontario
Canada	Chum Hopital Notre Dame; Centre D'Oncologie	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
France	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
Poland	Bialostockie Centrum Onkologi	Bialystok
Poland	Wojewodzkie Centrum Onkologii	Gdansk
Poland	Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON	Warszawa
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Vall d'Hebron; Servicio de Neumologia	Barcelona
Spain	HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
United Kingdom	Sarah Cannon Research Institute	London
United Kingdom	Christie Hospital	Manchester
United Kingdom	The Royal Marsden Hospital	Sutton
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton, Surrey
United Kingdom	The Clatterbridge Cancer Centre NHS Foundation Trust	Wirral
United States	Johns Hopkins Uni; Oncology Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Inst.	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Hematology & Oncology Associates	Covington	Louisiana
United States	Sarah Cannon Cancer Center	Germantown	Tennessee
United States	Oklahoma University Health Sciences Center	Oklahoma City	Oklahoma
United States	University of California Irvine Medical Center	Orange	California
United States	St. Joseph'S Hospital & Medical Center	Phoenix	Arizona
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Women & Infants Hospital	Providence	Rhode Island
United States	Florida Cancer Specialists.	Saint Petersburg	Florida
United States	HonorHealth Research Institute - Pima Center	Scottsdale	Arizona
United States	Northwest Cancer Specialists, P.C.	Tualatin	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Overall Survival (OS)		From baseline up to death from any cause (overall up to approximately 2.5 years)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)