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

NCT01497665 | Terminated Phase 2 Results DMC

• 1 other identifier: CP1005B017
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 10

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).

Conditions

Non-small Cell Lung Cancer (NSCLC) With Brain Metastases

Keywords

GRN1005; ANG1005; LRP-1; Targeted Therapy; Brain Tumor; Blood Brain Barrier; Peptide-Drug Conjugate (PDC); Brain Metastases; Paclitaxel; Taxol; NSCLC; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  upon enrollment through end of study period (1 year after last patient is enrolled)

Secondary Outcomes (4)

• 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)

• 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)

Study Arms (1)

GRN1005 alone

EXPERIMENTAL

GRN1005 alone

Drug: GRN1005

Interventions

GRN1005 DRUG

650 mg/m2 IV every 3 weeks

Also known as: ANG1005

GRN1005 alone

Eligibility Criteria

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

You may qualify if:

• Adult patients (≥ 18 years)
• Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)
• Brain metastases from NSCLC, which:
• have radiologically-progressed after WBRT or are present without prior WBRT
• 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.
• 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).
• Karnofsky Performance Score (KPS) ≥ 80%
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Angiochem Inc: lead

Study Sites (10)

Univ. of California San Diego

La Jolla, California, 92093, United States

Location

Univ. Coloardo at Denver

Aurora, Colorado, 80045, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern Univ.

Chicago, Illinois, 60611, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Univ. of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

McGill Univ.

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

paclitaxel-Angiopep-2 conjugate

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Betty Lawrence, Vice President, Development
• Organization: Angiochem Inc.

blawrence@angiochem.com

514-788-7800

Study Officials

• Betty Lawrence

  Angiochem Inc

  STUDY DIRECTOR

• Patrick Wen, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 22, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 22, 2019
• Results First Posted: December 14, 2015

Record last verified: 2019-01

Locations

US (9); CA (1)