A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression

NCT02005484 | Terminated Phase 2 Results

• 1 other identifier: ML17263
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 12

Brief Summary

This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category

  Tumor response assessed according to RECIST. Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\]10 millimeters \[mm\]); no new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD). Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).

  Weekly throughout study

Secondary Outcomes (6)

• Percentage of Participants With Clinical Benefit

  Weekly throughout the study

• Percentage of Participants With a Best Overall Response of CR or PR

  Weekly throughout the study

• Overall Survival - Number of Participants Who Died

  Weekly throughout the study

• Overall Survival

  Weekly throughout the study

• Time to Progression - Number of Participants With an Event

  Weekly throughout the study

Study Arms (1)

Trastuzumab Monotherapy

EXPERIMENTAL

Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

4 mg/kg initial dose, followed by 2 mg/kg

Also known as: Herceptin

Trastuzumab Monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients 18-75 years of age;
• metastatic or advanced gastric cancer;
• disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
• \>=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
• \>=1 measurable lesion;
• HER2 overexpression (IHC \[2+\] or \[3+\]).

You may not qualify if:

• concurrent chemotherapy or immunotherapy;
• brain or meningeal metastases;
• clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
• co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
• women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Dresden, 01307, Germany

Location

Unknown Facility

Erlangen, 91054, Germany

Location

Unknown Facility

Essen, 45122, Germany

Location

Unknown Facility

Grenzach-Wyhlen, 79639, Germany

Location

Unknown Facility

Halle, 06120, Germany

Location

Unknown Facility

Kassel, 34125, Germany

Location

Unknown Facility

Kiel, 24105, Germany

Location

Unknown Facility

Mannheim, 68167, Germany

Location

Unknown Facility

München, 81377, Germany

Location

Unknown Facility

München, 81675, Germany

Location

Unknown Facility

Oldenburg, 26133, Germany

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to slow patient recruitment, the study was prematurely terminated.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-07

Locations

AU (1); DE (11)