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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01469793
First received: November 7, 2011
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This multicenter, open-label, dose-escalating study will assess the safety and e fficacy of DMOT4039A in patients with unresectable pancreatic or platinum-resist ant ovarian cancer. Cohorts of patients will receive multiple ascending intraven ous doses of DMOT4039A. Anticipated time on study treatment is up to 1 year or u ntil disease progression occurs.


Condition Intervention Phase
Ovarian Cancer, Pancreatic Cancer
Drug: DMOT4039A
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 71
Study Start Date: November 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: DMOT4039A
multiple ascending doses

  Eligibility

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

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
  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: NCT01469793

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85259
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Rochester, Minnesota, United States, 55905
Netherlands
Amsterdam, Netherlands, 1081 HV
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Genentech
Investigators
Study Director: Daniel Maslyar, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01469793     History of Changes
Other Study ID Numbers: DMO4993g, GP27896
Study First Received: November 7, 2011
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders

ClinicalTrials.gov processed this record on September 30, 2014