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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer (NSCLC) With Brain Metastases

Thank you

Trial Information

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


Key

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall (intra-cranial and extra-cranial) objective response rate in non-small cell lung cancer (NSCLC) patients with brain metastasis

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Jean-Paul Castaigne, MD

Investigator Role:

Study Director

Investigator Affiliation:

Angiochem Inc

Authority:

United States: Food and Drug Administration

Study ID:

CP1005B017

NCT ID:

NCT01497665

Start Date:

November 2011

Completion Date:

December 2013

Related Keywords:

  • Non-small Cell Lung Cancer (NSCLC) With Brain Metastases
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

Name

Location

Ingalls Memorial HospitalHarvey, Illinois  60426
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Karmanos Cancer InstituteDetroit, Michigan  48201
Tennessee OncologyNashville, Tennessee  37203
Northwestern Univ.Chicago, Illinois  60611
Univ. of California San DiegoLa Jolla, California  92093
Univ. Coloardo at DenverAurora, Colorado  80045
Univ. of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15232