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Safety and Pharmacokinetics of DMUC5754A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01335958
First Posted: April 15, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
April 13, 2011
April 15, 2011
November 2, 2016
April 2011
February 2014   (Final data collection date for primary outcome measure)
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 21 days ]
  • Nature of dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.0 [ Time Frame: Up to 21 days ]
Same as current
Complete list of historical versions of study NCT01335958 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events [ Time Frame: Up to 1 year ]
  • Nature of adverse events graded per NCI CTCAE v4.0 [ Time Frame: Up to 1 year ]
  • Severity of adverse events [ Time Frame: Up to 1 year ]
  • Area under the concentration-time curve [ Time Frame: up to 1 year ]
  • Maximum concentrations [ Time Frame: up to 1 year ]
  • Minimum concentrations [ Time Frame: up yo 1 year ]
  • Clearance [ Time Frame: up to 1 year ]
  • Half-life [ Time Frame: up to 1 year ]
  • Volume of distribution [ Time Frame: up to 1 year ]
  • Incidence of adverse events [ Time Frame: Up to 1 year ]
  • Nature of adverse events graded per NCI CTCAE v4.0 [ Time Frame: Up to 1 year ]
  • Severity of adverse events [ Time Frame: Up to 1 year ]
Not Provided
Not Provided
 
Safety and Pharmacokinetics of DMUC5754A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer
A Phase I, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of DMUC5754A Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer
This is a Phase I, multi-center, open-label, dose-escalation study of DMUC5754A administered as a single agent by intravenous (IV) infusion to patients with platinum-resistant ovarian cancer or unresectable pancreatic cancer.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer, Pancreatic Cancer
Drug: DMUC5754A
Escalating intravenous dose
Experimental: A
Intervention: Drug: DMUC5754A
Liu JF, Moore KN, Birrer MJ, Berlin S, Matulonis UA, Infante JR, Wolpin B, Poon KA, Firestein R, Xu J, Kahn R, Wang Y, Wood K, Darbonne WC, Lackner MR, Kelley SK, Lu X, Choi YJ, Maslyar D, Humke EW, Burris HA. Phase I study of safety and pharmacokinetics of the anti-MUC16 antibody-drug conjugate DMUC5754A in patients with platinum-resistant ovarian cancer or unresectable pancreatic cancer. Ann Oncol. 2016 Nov;27(11):2124-2130.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
February 2014
February 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Life expectancy of at least 12 weeks
  • Documented willingness to use an effective means of contraception for women of childbearing potential
  • Measurable disease with at least one lesion that can be accurately measured in at least one dimension

Inclusion Criteria Specific to Patients with Ovarian Cancer:

  • Advanced, epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months of the most recent treatment with a platinum-containing chemotherapy regimen, and for which no standard therapy exists
  • For patients in the dose-expansion cohort of the study only, no more than two prior chemotherapy regimens for the treatment of platinum-resistant ovarian cancer

Inclusion Criteria Specific to Patients with Pancreatic Cancer:

  • Incurable, locally advanced, or metastatic disease for which no standard therapy exists, consisting of unresectable pancreatic ductal adenocarcinoma, including recurrence of previously-resected disease that is considered unresectable with curative intent
  • No more than one chemotherapy regimen (approved or experimental) administered in the metastatic setting

Exclusion Criteria:

  • Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to Day 1
  • Palliative radiation to bone metastases within 2 weeks prior to Day 1
  • Major surgical procedure within 4 weeks prior to Day 1
  • Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
  • Current Grade >1 toxicity (except alopecia and anorexia) from prior therapy or Grade >1 neuropathy from any cause
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the CNS, radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study, and the screening CNS radiographic study is >= 8 weeks since completion of radiotherapy and >= 4 weeks since the discontinuation of corticosteroids and anticonvulsants.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmias, and unstable angina); nervous system, pulmonary (including obstructive pulmonary disease and history of symptomatic bronchospasm), renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
  • Pregnancy or breast-feeding
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01335958
DGR4980g
GO00766 ( Other Identifier: Hoffmann-La Roche )
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP