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

Phase 2

Terminated

• Conditions: Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
• Interventions: Drug: GRN1005

• Registration Number: NCT01497665
• Lead Sponsor: Angiochem Inc

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-22
• Primary Completion: 2013-01
• Study Completion: 2013-02
• Results First Submitted: 2015-05-12
• Results First Submitted QC: 2015-11-10
• Results First Posted: 2015-12-14
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Adult patients (≥ 18 years)

2. Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)

3. Brain metastases from NSCLC, which:

   have radiologically-progressed after WBRT or are present without prior WBRT

4. At least one radiologically-confirmed and measurable lesion (≥ 1.0 cm in the longest diameter) within14 days prior to the first dose of GRN1005 (Cycle 1, Day 1), as follows: an intra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by Gd-MRI, or an extra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by MRI or CT scan with contrast Prior stereotactic radiosurgery (SRS) is allowed; however, metastatic brain lesions previously treated with SRS are not allowed as target or as non-target lesions.

5. Patients must be neurologically stable, defined as being on stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose of GRN1005 (Cycle 1, Day 1).

6. Karnofsky Performance Score (KPS) ≥ 80%

7. Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose of GRN1005 (with the exception of local radiation therapy for palliation to extra-cranial sites, i.e., bone). All clinically significant toxicities must have resolved to ≤ NCI CTCAE v4.0 Grade 1.0.

Key

Exclusion Criteria

1. NCI CTCAE v4.0 Grade ≥ 2 neuropathy
2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
3. Known intra-cranial hemorrhage
4. Known leptomeningeal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GRN1005 alone	GRN1005	GRN1005 alone

Primary Outcome Measures

Name	Time	Method
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis	upon enrollment through end of study period (1 year after last patient is enrolled)	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Overall Objective Response	Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of Overall Progression Free Survival	Upon enrollment through end of study period (1 year after last patient is enrolled)
Six Month Overall Survival	Upon enrollment through end of study period (1 year after last patient is enrolled)
Number of Patients With Adverse Events as a Measure of Safety and Tolerability	Upon enrollment through end of study period (1 year after last patient is enrolled)

Trial Locations

Locations (10)

Northwestern Univ.; 🇺🇸 Chicago, Illinois, United States

Univ. of California San Diego; 🇺🇸 La Jolla, California, United States

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

Univ. Coloardo at Denver; 🇺🇸 Aurora, Colorado, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Ingalls Memorial Hospital; 🇺🇸 Harvey, Illinois, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Univ. of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

McGill Univ.; 🇨🇦 Montreal, Quebec, Canada

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States