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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01991210
First received: November 15, 2013
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

This randomized, multicenter, open-label study will evaluate the safety and effi cacy of DNIB0600A in comparison with pegylated liposomal doxorubicin (PLD) in pa tients with platinum-resistant ovarian cancer, primary peritoneal cancer or fall opian tube cancer. Patients will be randomized to receive either DNIB0600A 2.4 m g/kg intravenously every three weeks or PLD 40 mg/m2 intravenously every four we eks. Anticipated time on study treatment is until disease progression or unaccep table 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
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

Resource links provided by NLM:


Further study details as provided by Genentech:

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 ]

Estimated Enrollment: 92
Study Start Date: February 2014
Estimated Study Completion Date: July 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991210

Contacts
Contact: Reference Study ID Number: GO28609 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 34 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01991210     History of Changes
Other Study ID Numbers: GO28609, 2012-005776-34
Study First Received: November 15, 2013
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
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
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014