Safety And Pharmacokinetics Of DMUC5754A Administered Intravenously To Patients With Platinum-Resistant Ovarian Cancer Or Unresectable Pancreatic Cancer

Study Overview

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.

N/A

Ovarian Cancer, Pancreatic Cancer

DRUG: DMUC5754A

DGR4980g
GO00766 (OTHER Identifier) (OTHER: Hoffmann-La Roche)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-04-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-11-01
First Submitted that Met QC Criteria 2011-04-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-11-02
First Posted (ESTIMATED) 2011-04-15	Results First Posted N/A	Last Verified 2016-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: A	DRUG: DMUC5754A Escalating intravenous dose

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: A

DRUG: DMUC5754A

Escalating intravenous dose

Primary Outcome Measures	Measure Description	Time Frame
Incidence of dose-limiting toxicities (DLTs)		Up to 21 days
Nature of dose-limiting toxicities (DLTs) graded per NCI CTCAE v4.0		Up to 21 days

Secondary Outcome Measures	Measure Description	Time Frame
Incidence of adverse events		Up to 1 year
Nature of adverse events graded per NCI CTCAE v4.0		Up to 1 year
Severity of adverse events		Up to 1 year
Area under the concentration-time curve		up to 1 year
Maximum concentrations		up to 1 year
Minimum concentrations		up yo 1 year
Clearance		up to 1 year
Half-life		up to 1 year
Volume of distribution		up to 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Clinical Trials, Genentech, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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. doi: 10.1093/annonc/mdw401.

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Clinical Trial Record