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

Skin and Connective Tissue Diseases

Breast Neoplasms

Neoplasms, Second Primary

Breast Diseases

Skin Diseases

Anti-Infective Agents

Trastuzumab

Alovudine

Antineoplastic Agents, Immunological

Antiviral Agents

GRN1005 alone in HER2- MBC patients with brain mets. 18F-FLT may also be administered to this arm (if patient enrolled at NCI)

GRN1005 in combination with trastuzumab in MBC patients with brain mets 18F-FLT may also be administered to this arm (if patient enrolled at NCI)

2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice

5 mCi of 18F-FLT IV during Screening and during Cycle 1

18F-FLT

Nancy Lin, MD

Susan Bates, MD

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice.

In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).

GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

Recurrence

Triple Negative Breast Neoplasms

Participants received ANG1005 intravenously (IV) at a dose of 600 mg/m\^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated.

ANG1005

This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.

ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GRN1005 in Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastases (GRABM-L)	NCT01497665	Non-small Cell ...	GRN1005	18 Years -	Angiochem Inc
GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases	NCT01480583	Breast Cancer Brain Metastase...	GRN1005 Trastuzumab 18F-FLT	18 Years -	Angiochem Inc
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases	NCT02048059	Breast Cancer Brain Metastase...	ANG1005	18 Years -	Angiochem Inc

Spots Global Cancer Trial Database for grn1005

Every month we try and update this database with for grn1005 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for grn1005

Every month we try and update this database with for grn1005 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for grn1005 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.