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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01991210
Collaborator
(none)
95
Enrollment
36
Locations
2
Arms
30.3
Actual Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 6, 2014
Actual Primary Completion Date :
Aug 17, 2016
Actual Study Completion Date :
Aug 17, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: DNIB0600A
DNIB0600A will be administered at a dose of 2.4 mg/kg IV every 3 weeks.
Other Names:
  • RO5541081

    		•
    Active Comparator: 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).

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

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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)]

    2. 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)]

    3. Overall Survival (OS) [From baseline up to death from any cause (overall up to approximately 2.5 years)]

    4. 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)]

    5. 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]

    6. 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]

    7. 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]

    8. 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]

    9. 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]

    10. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Joseph'S Hospital & Medical Center Phoenix Arizona United States 85013
    2 HonorHealth Research Institute - Pima Center Scottsdale Arizona United States 85258
    3 University of California Irvine Medical Center Orange California United States 92868
    4 Florida Cancer Specialists. Saint Petersburg Florida United States 33705
    5 Hematology & Oncology Associates Covington Louisiana United States 70433
    6 Johns Hopkins Uni; Oncology Center Baltimore Maryland United States 21231
    7 Massachusetts General Hospital Boston Massachusetts United States 02114
    8 Dana Farber Cancer Inst. Boston Massachusetts United States 02115
    9 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    10 Oklahoma University Health Sciences Center Oklahoma City Oklahoma United States 73104
    11 Northwest Cancer Specialists, P.C. Tualatin Oregon United States 97062
    12 Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
    13 Women & Infants Hospital Providence Rhode Island United States 02905
    14 Sarah Cannon Cancer Center Germantown Tennessee United States 38138
    15 UZ Leuven Gasthuisberg Leuven Belgium 3000
    16 CHU Sart-Tilman Liège Belgium 4000
    17 London Regional Cancer Centre London Ontario Canada N6A 4L6
    18 Princess Margaret Hospital Toronto Ontario Canada M4X 1K9
    19 Chum Hopital Notre Dame; Centre D'Oncologie Montreal Quebec Canada H2L 4M1
    20 Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes Lyon France 69008
    21 Hôpital Européen Georges Pompidou Paris France 75908
    22 HOPITAL TENON; Cancerologie Medicale Paris France 75970
    23 Institut Gustave Roussy Villejuif France 94805
    24 Bialostockie Centrum Onkologi Bialystok Poland 15-027
    25 Wojewodzkie Centrum Onkologii Gdansk Poland 80-219
    26 Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON Warszawa Poland 04-141
    27 Hospital Universitario Vall d'Hebron; Servicio de Neumologia Barcelona Spain 08035
    28 Hospital Clinic de Barcelona Barcelona Spain 08036
    29 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
    30 Hospital Universitario 12 de Octubre Madrid Spain 28041
    31 HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia Madrid Spain 28050
    32 Sarah Cannon Research Institute London United Kingdom W1G 6AD
    33 Christie Hospital Manchester United Kingdom M20 3BG
    34 Royal Marsden NHS Foundation Trust Sutton, Surrey United Kingdom SM2 5PT
    35 The Royal Marsden Hospital Sutton United Kingdom SM2 5PT
    36 The Clatterbridge Cancer Centre NHS Foundation Trust Wirral United Kingdom L63 4JY

    Sponsors and Collaborators

    • Genentech, Inc.

    Investigators

    • Study Director: Clinical Trials, Genentech, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT01991210
    Other Study ID Numbers:
    • GO28609
    • 2012-005776-34
    First Posted:
    Nov 25, 2013
    Last Update Posted:
    Aug 21, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Aug 21, 2017