A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01598077
First received: May 4, 2012
Last updated: March 14, 2014
Last verified: March 2014

May 4, 2012
March 14, 2014
July 2012
June 2014   (final data collection date for primary outcome measure)
Dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01598077 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Experimental: Dose escalation and dose expansion
Intervention: Drug: LJM716
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
54
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Korea, Republic of,   Spain,   Taiwan
 
NCT01598077
CLJM716X2101, 2011-004865-33
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2014

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