Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Brain Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

GRN1005

Betty Lawrence

Patrick Wen, MD

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from non-small cell lung cancer (NSCLC).

GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)

A Phase II, Multi-center, Open-label Study Evaluating the Efficacy and Safety of GRN1005 in Non-Small Cell Lung Cancer Patients With Brain Metastases

Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), \< 30% decrease but \<20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), \>= 20% (\>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR.

Angiochem Inc

All SAEs and all Other (not including serious) AEs are reported regardless of attribution.

GRN1005 alone

GRN1005: 650 mg/m2 IV every 3 weeks

GRN1005 Alone

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

1. Safety population (all patients): 16
2. Efficacy population (defined as the number of patients who had ≥1 intracranial lesions followed as target or non-target lesions, and who were evaluated by Overall RECIST v.1.1):10

Betty Lawrence, Vice President, Development

Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis

Number of Patients With Adverse Events as a Measure of Safety and Tolerability

Once the study was terminated, no further data on response was collected and there was insufficient number of participants with data collected for this outcome measure.

Duration of Overall Objective Response

Once the study was terminated, no further efficacy data was collected and there was insufficient number of participants with data collected for this outcome measure.

Duration of Overall Progression Free Survival

Once the study was terminated, no further survival data was collected and there was insufficient number of participants with data collected for this outcome measure.

Six Month Overall Survival

Overall Study

Spots Global Cancer Trial Database for GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial