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:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01469793
First received: November 7, 2011
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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.
| 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 ]
| Estimated Enrollment: | 77 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469793
Contacts
| Contact: Please reference Study ID Number: GP27896 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, Arizona | |
| Recruiting | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, Colorado | |
| Recruiting | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Recruiting | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Minnesota | |
| Recruiting | |
| Rochester, Minnesota, United States, 55905 | |
| Netherlands | |
| Recruiting | |
| Amsterdam, Netherlands, 1081 BT | |
| Recruiting | |
| 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: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Pancreatic Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Digestive System Neoplasms Digestive System Diseases Pancreatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013