A Study of DMOT4039A in Patients With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer

This study is currently recruiting participants.

Verified May 2013 by Genentech

Sponsor:

Information provided by (Responsible Party):

Genentech

ClinicalTrials.gov Identifier:

NCT01469793

First received: November 7, 2011

Last updated: May 14, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 7, 2011

Last Updated Date

May 14, 2013

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety: Incidence of adverse events [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]
Safety: Maximum tolerated dose/dose-limiting toxicities [ Time Frame: approximately 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01469793 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics: area under the concentration-time curve (AUC) [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]
Immunogenicity: Serum anti-therapeutic antibody levels [ Time Frame: approximately 1 years ] [ Designated as safety issue: No ]
Objective response (complete response or partial response), tumor assessments according to RECIST criteria [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of DMOT4039A in Patients With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer

Official Title ^ICMJE

A Phase I, Open Label Study of the Safety and Pharmacokinetics of Escalating Doses of DMOT4039A in Patients With Unresectable Pancreatic or Platinum Resistant Ovarian Cancer

Brief Summary

This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DMOT4039A in patients with unresectable pancreatic or platinum-resistant ovarian cancer. Cohorts of patients will receive multiple ascending intravenous doses of DMOT4039A. Anticipated time on study treatment is up to 1 year or until disease progression occurs.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Ovarian Cancer, Pancreatic Cancer

Intervention ^ICMJE

Drug: DMOT4039A

multiple ascending doses

Study Arm (s)

Experimental: A

Intervention: Drug: DMOT4039A

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2015

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients, >/= 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer
Measureable disease, defined as at least one bi-dimensionally measurable non-lymph node lesion >/= 1 cm in long-axis diameter on spiral CT scan or at least one bi-dimensionally measurable lymph node measuring >/= 1.5 cm in short-axis diameter on spiral CT scan
Adequate hematological, renal and liver function

Exclusion Criteria:

Treatment with anti-tumor therapy, including chemotherapy, biologic, experimental or hormonal therapy, within 4 weeks prior to Day 1
Known active infection
Current Grade >/= 2 toxicity (except for alopecia, anorexia and fatigue) from prior therapy or Grade >/= 2 neuropathy
Untreated or active cerebral nervous system (CNS) metastases
Pregnant or breastfeeding women

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: GP27896 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

United States, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01469793

Other Study ID Numbers ^ICMJE

DMO4993g, GP27896

Has Data Monitoring Committee

Not Provided

Responsible Party

Genentech

Study Sponsor ^ICMJE

Genentech

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Daniel Maslyar, M.D.

Genentech

Information Provided By

Genentech

Verification Date

May 2013

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

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