Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas

NCT01433263 | Completed Phase 2 Results

• 1 other identifier: CBYM338X2202
• Study Type: interventional
• Target: 57
• Locations: 5 countries
• Sites: 10

Brief Summary

A safety \& efficacy clinical study of the investigational medicinal product BYM338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas

Conditions

Cachexia

Keywords

Wasting syndrome; emaciation; lung cancer; adenocarcinoma; pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8

  Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.

  Baseline, week 8

Secondary Outcomes (9)

• Percentage Change in Body Weight From Baseline at Week 7 and Week 9

  Baseline, Week 7 and Week 9

• Maximum Observed Serum Concentration (Cmax)

  0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8

• Time to Reach the Maximum Concentration After Drug Administration (Tmax)

  0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8

• Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8

  Baseline, Week 8

• Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8

  Baseline, Week 8

Study Arms (2)

30mg/kg BYM338

EXPERIMENTAL

Drug: BYM338 active drug

Placebo / late 30mg/kg BYM338

PLACEBO COMPARATOR

Drug: BYM338 active drug; Drug: Placebo

Interventions

BYM338 active drug DRUG

30mg/kg BYM338; Placebo / late 30mg/kg BYM338

Placebo DRUG

Placebo / late 30mg/kg BYM338

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must sign an informed consent before assessment
• 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.
• Patients with stage IV NSCLC will be receiving or completed or discontinued standard chemotherapy or be chemotherapy-naive by choice.
• 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.
• 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.
• Body mass index (BMI) ≤ 30 kg/m2.
• Life expectancy of at least 4 months.
• Able to communicate well and comply with the requirements of the study, including by phone and written logs.

You may not qualify if:

• Patients who have received investigational anti-neoplastic therapy within 3 weeks of screening
• Evidence of inadequate organ or brain function, as defined by lab tests and imaging
• 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
• Pregnant or lactating women.
• 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
• Patients unwilling or unable to follow instructions.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Tucson, Arizona, 85715, United States

Location

Novartis Investigative Site

Tampa, Florida, 33647, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60611-3308, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02114, United States

Location

Novartis Investigative Site

Canton, Ohio, 44718, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78217, United States

Location

Novartis Investigative Site

Vilnius, LT 08661, Lithuania

Location

Novartis Investigative Site

Bucharest, Sector 5, Romania

Location

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

Location

Novartis Investigative Site

Edinburgh, EH10 5HF, United Kingdom

Location

Related Publications (1)

• Epstein SA, Doles JD, Dasgupta A. KLF10: a point of convergence in cancer cachexia. Curr Opin Support Palliat Care. 2024 Sep 1;18(3):120-125. doi: 10.1097/SPC.0000000000000711. Epub 2024 Jul 15.

  PMID: 39007915 DERIVED

MeSH Terms

Conditions

Cachexia; Wasting Syndrome; Emaciation; Lung Neoplasms; Adenocarcinoma; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: September 13, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 2, 2016
• Results First Posted: May 13, 2015

Record last verified: 2016-02

Locations

CH (1); LI (1); RO (1); US (6); GB (1)