Trial record 1 of 2892 for:
Open Studies | "Carcinoma"
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
This study is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01598077
First received: May 4, 2012
Last updated: May 8, 2013
Last verified: May 2013
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Purpose
This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer
| Condition | Intervention | Phase |
|---|---|---|
|
HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma HER2 + Breast Cancer HER2 + Gastric Cancer Squamous Cell Carcinoma of Head and Neck Esophageal Squamous Cell Carcinoma |
Drug: LJM716 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of LJM716 in Patients With Squamous Cell Carcinoma of Head and Neck, or HER2 Overexpressing Metastatic Breast Cancer or Gastric Cancer |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Serious adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Pharmacodynamic response to LJM716 in tumor tissue [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Frequency of partial responses, complete responses and stable disease according to RECIST [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
- Serum concentration of antibodies to LJM716 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Serum concentration of LJM716, [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose escalation and dose expansion | Drug: LJM716 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients with HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma
- Site of disease that can be safely biopsied
Exclusion criteria:
- Patients received prior anti-HER3 antibody treatment
- Patients with impaired cardiac function
- Brain metastases that have not been adequately treated
- Malignant disease other than that being treated in this study
- Pregnant or nursing (lactating) women
- Laboratory abnormalities as specified in the protocol Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598077
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Locations
| United States, Illinois | |
| University of Chicago Medical Center University of Chicago (16) | Recruiting |
| Chicago, Illinois, United States, 60546 | |
| Contact: David Geary 773-702-2452 dgeary@medicine.bsd.uchicago.edu | |
| Principal Investigator: Ezra Cohen | |
| United States, Massachusetts | |
| Massachusetts General Hospital SC-5 | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Rosemary Boyle rboyle1@partners.org | |
| Principal Investigator: Dejan Juric | |
| United States, Texas | |
| MD Anderson Cancer Center/University of Texas UT MD | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Sara Nasser 713-792-3391 snasser@mdanderson.org | |
| Principal Investigator: George Blumenschein | |
| United States, Utah | |
| University of Utah / Huntsman Cancer Institute Huntsman | Recruiting |
| Salt Lake City, Utah, United States, 84103 | |
| Contact: Danielle Tometich 801-585-0443 danielle.tometich@hci.utah.edu | |
| Principal Investigator: Ignacio Garrido-Laguna | |
| Canada, Ontario | |
| Novartis Investigative Site | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Korea, Republic of | |
| Novartis Investigative Site | Recruiting |
| Seoul, Korea, Korea, Republic of, 110 744 | |
| Spain | |
| Novartis Investigative Site | Recruiting |
| Barcelona, Cataluna, Spain, 08035 | |
| Taiwan | |
| Novartis Investigative Site | Recruiting |
| Taipei, Taiwan, 10002 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01598077 History of Changes |
| Other Study ID Numbers: | CLJM716X2101, 2011-004865-33 |
| Study First Received: | May 4, 2012 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Spain: Ministry of Health Korea: Food and Drug Administration Taiwan : Food and Drug Administration |
Keywords provided by Novartis:
|
Breast cancer, gastric cancer, squamous cell carcinoma of head and neck, esophageal squamous cell carcinoma Breast cancer Gastric cancer Squamous cell carcinoma of head and neck Esophageal squamous cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Breast Neoplasms Esophageal Diseases Stomach Neoplasms Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Stomach Diseases |
ClinicalTrials.gov processed this record on May 23, 2013