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A Randomized, Double-blind, Placebo-controlled Multi-center Study of BYM338 for Treatment of Cachexia in Patients With Stage IV Non-small Cell Lung Cancer or Stage III/IV Adenocarcinoma of the Pancreas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cachexia

Thank you

Trial Information

A Randomized, Double-blind, Placebo-controlled Multi-center Study of BYM338 for Treatment of Cachexia in Patients With Stage IV Non-small Cell Lung Cancer or Stage III/IV Adenocarcinoma of the Pancreas

Inclusion Criteria


Key Inclusion criteria:

1. Patients must sign an informed consent before assessment

2. Patients with pathologically and/or clinically confirmed diagnosis of stage IV
non-small (squamous or non-squamous) cell lung cancer (NSCLC) or stage III/IV
adenocarcinoma of the pancreas.

3. Patients with stage IV NSCLC will be receiving or completed or discontinued standard
chemotherapy or be chemotherapy-naive by choice.

4. Patients with stage III/IV pancreatic adenocarcinoma will be receiving standard
chemotherapy or no chemotherapy. If patients are receiving chemotherapy, a change in
chemotherapy is not expected.

5. Greater than or equal to 5% unintentional weight loss over the previous 3-6 months,
not explained by simple starvation. Simple starvation is considered to be excluded
when weight loss is not ameliorated by standard nutritional counseling and oral
supplementation over a 2 week period.

6. Body mass index (BMI) ≤ 30 kg/m2.

7. Life expectancy of at least 4 months.

8. Able to communicate well and comply with the requirements of the study, including by
phone and written logs.

Key Exclusion criteria:

1. Patients who have received investigational anti-neoplastic therapy within 3 weeks of
screening

2. Evidence of inadequate organ or brain function, as defined by lab tests and imaging

3. Patients with severe and/or uncontrolled medical conditions that could interfere with
the study (e.g. heart conditions, high blood pressure, diabetes, infection)
uncontrolled pain or any other non-stable illness

4. Pregnant or lactating women.

5. Women capable of becoming pregnant must use highly effective contraception during the
study and for 8 weeks after stopping treatment. All female patients must have
negative pregnancy test results throughout the study

6. Patients unwilling or unable to follow instructions.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Increase in thigh muscle volume as measured by MRI

Outcome Time Frame:

8 Weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceiticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBYM338X2202

NCT ID:

NCT01433263

Start Date:

August 2011

Completion Date:

May 2013

Related Keywords:

  • Cachexia
  • Wasting syndrome
  • emaciation
  • lung cancer
  • adenocarcinoma
  • pancreatic cancer
  • Adenocarcinoma
  • Cachexia
  • Lung Neoplasms

Name

Location

Novartis Investigative SiteChicago, Illinois  60612
Novartis Investigative SiteBoston, Massachusetts  02115
Novartis Investigative SiteSacramento, California  95817
Novartis Investigative SiteSt. Louis, Missouri  63110
Novartis Investigative SiteBuffalo, New York  14263
Novartis Investigative SiteCleveland, Ohio  44195
Novartis Investigative SiteTucson, Arizona  85724
Novartis Investigative SiteMiami, Florida  33176-2197
Novartis Investigative SiteMinneapolis, Minnesota  55455
Novartis Investigative SiteDallas, Texas  75235-9179