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A Randomized Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin in Patients With Platinum-Resistant Ovarian Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: November 15, 2013
Last updated: December 1, 2015
Last verified: December 2015
This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A in comparison with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant ovarian cancer, primary peritoneal cancer or fallopian tube cancer. Patients will be randomized to receive either DNIB0600A 2.4 mg/kg intravenously every three weeks or PLD 40 mg/m2 intravenously every four weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Condition Intervention Phase
Ovarian Cancer, Epithelial Tumors, Malignant, Fallopian Tube Cancer, Peritoneal Neoplasms
Drug: DNIB0600A
Drug: pegylated liposomal doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: up to approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response (complete response or partial response) [ Time Frame: up to approximately 2.5 years ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: up to approximately 2.5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to approximately 2.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 2.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Cycles 1-4, up to approximately 2.5 years ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies (ATAs) [ Time Frame: Day 1 every cycle, up to approximately 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: February 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DNIB0600A Drug: DNIB0600A
2.4 mg/kg IV every three weeks
Active Comparator: PLD Drug: pegylated liposomal doxorubicin
40 mg/m2 IV every four weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • 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 one prior chemotherapy regimens for the treatment of PROC (chemotherapy is defined as any cytotoxic, biologic, or targeted therapy [approved or investigational] with intent to treat the ovarian cancer)
  • Adequate hematologic, renal and liver function
  • Willing and able to perform a PRO survey (including the possibility of using an electronic PRO device)
  • For women of childbearing potential, agreement to use one highly effective form of contraception as defined by protocol through the course of study treatment and for 3 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 (e.g., Doxil®, Caelyx®, or Lipodox®) in any setting (e.g., 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 > 1 toxicity (except alopecia and anorexia) from prior therapy or Grade >1 neuropathy from any cause
  • Left ventricular ejection fraction defined by 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 if all of the following criteria are met:
  • Stage </= IB
  • Superficial myometrial invasion without vascular or lymphatic invasion
  • No poorly differentiated subtypes (i.e., papillary serous, clear cell, or other Federation of Gynecology and Obstetrics [FIGO] Grade 3 lesions)
  • Untreated or active central nervous system metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
  • Pregnancy or breastfeeding
  • Known history of NaPi2b deficiency (e.g., 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 gving reasonable suspicion of a disease or condition that contraindicated use of an investigational drug or may render the patient at high risk from treatment complications
  Contacts and Locations
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Please refer to this study by its identifier: NCT01991210

  Show 36 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01991210     History of Changes
Other Study ID Numbers: GO28609  2012-005776-34 
Study First Received: November 15, 2013
Last Updated: December 1, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on January 14, 2017