Know Cancer

or
forgot password

A Multicenter, Open-label, Dose Escalation, Phase I Study of LJM716 Administered Intravenously in Combination With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast Cancer or Gastric Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced HER2-positive Breast Cancer or Gastric Cancer

Thank you

Trial Information

A Multicenter, Open-label, Dose Escalation, Phase I Study of LJM716 Administered Intravenously in Combination With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast Cancer or Gastric Cancer


Inclusion Criteria:



- Patients with confirmed HER-2 positive, metastatic or non-operable locally advanced
breast or gastric cancer

- Metastatic breast cancer patients must have received a minimum of 1 and a maximum of
3 prior anti HER2 based regimens with documented progression on the most recent
regimen which must contain trastuzumab, ado-trastuzumab emtansine or lapatinib

- Metastatic gastric cancer patients must have received a minimum of 1 and a maximum of
2 prior anti HER2 based regimens with documented progression on the most recent
regimen which must contain trastuzumab or ado-trastuzumab emtansine

- During the dose expansion part of study, all patients must have at least one
measurable lesion as defined by RECIST criteria.

- Patients must have at least one prior trastuzumab-containing regimen

- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

Exclusion Criteria:

- Patients with Central Nervous System (CNS) metastasis which are: symptomatic or
require treatment for symptom control and/or growing

- Prior treatment with any anti-HER3 (Human Epidermal growth factor Receptor 3)
treatment

- Impaired cardiac function

- Prior to the first dose of study treatment, patients who have received systemic
antineoplastic therapy or any investigational therapy within 4 weeks or within 5
half- lives of the therapy prior to starting study treatment, whichever is shorter,
or for cyclical therapy, within one cycle length (e.g. 6 weeks for nitrosourea,
mitomycin-C).

- Patients who have a history of primary malignancy other than that being treated in
this study, and currently requires active clinical intervention.

- Patients who do not have an archival tumor sample (or sections of it) available or
readily obtainable.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence rate of Dose Limiting Toxicities

Outcome Description:

Incidence of dose-limiting toxicities (DLTs)

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLJM716X2102

NCT ID:

NCT01602406

Start Date:

September 2012

Completion Date:

August 2014

Related Keywords:

  • Advanced HER2-positive Breast Cancer or Gastric Cancer
  • Advanced HER2-positive Breast cancer or Gastric cancer
  • Breast Neoplasms
  • Stomach Neoplasms

Name

Location

Massachusetts General Hospital SC-5Boston, Massachusetts  02114
UNC/Lineberg Comprehensive Cancer Center UNC 2Chapel Hill, North Carolina  27514
Duke University Medical Center SCDurham, North Carolina  27710
Fox Chase Cancer Center FCC 2Philadelphia, Pennsylvania  19111-2497