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



Status:Completed
Conditions:Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/18/2017
Start Date:February 2014
End Date:August 2016

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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

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.


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
We found this trial at
25
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Baltimore, MD
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Boston, Massachusetts 02115
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Covington, LA
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49 Herestraat
Leuven, 3000
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Leuven,
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Nashville, TN
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Sarah Cannon Cancer Center People who live with cancer
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Oklahoma City, Oklahoma 73104
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Orange, CA
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101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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Phoenix, AZ
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Pittsburgh, Pennsylvania 15213
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Providence, Rhode Island 02905
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Scottsdale, Arizona 85258
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St.Petersburg, Florida 33705
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Tualatin, OR
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