NCT00539383

Brief Summary

This is a phase 1, multi-centre, sequential cohort, open-label, dose-escalation study of the safety, tolerability, and PK of ANG1005 in patients with solid tumors (with or without brain metastases). ANG1005 will be given by IV infusion once every 21 days (1 treatment cycle). Each patient will participate in only 1 dose group and will receive up to 6 cycles of treatment provided there is no evidence of tumor progression, there is recovery to ≤Grade 1 or baseline nonhematologic, ANG1005-related toxicity (except alopecia), the absolute neutrophil count is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2007

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

2.4 years

First QC Date

October 3, 2007

Last Update Submit

July 30, 2014

Conditions

Advanced Solid Tumors With and Without Brain Metastases

Keywords

Lung cancerBreast cancerMelanomaHepatocellular carcinomaBrain metastases

Outcome Measures

Primary Outcomes (2)

  • To characterize the safety and tolerability of intravenously administered ANG1005 in patients with advanced solid tumors and metastatic brain cancer.

    On-going

  • To identify the maximum tolerated dose (MTD) of ANG1005 in patients with advanced solid tumors and metastatic brain cancer.

    End of dose escalation

Secondary Outcomes (4)

  • To examine the pharmacokinetics (PK) of ANG1005.

    End of study

  • To confirm the safety and tolerability of ANG1005 at the MTD.

    End of dose escalation

  • To assess the immunogenicity of ANG1005.

    End of study

  • To obtain preliminary information on the antitumor activity of ANG1005 in patients with advanced solid tumors with brain metastases.

    On-going

Study Arms (1)

1

EXPERIMENTAL
Drug: ANG1005

Interventions

ANG1005DRUG

IV infusion once every 21 days

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Histologically or cytologically confirmed metastatic or advance-stage solid tumor that has progressed following standard therapy or for which, in the opinion of the Investigator, no standard effective therapy is available; patients without brain metastases may be enrolled into the dose-escalation part of the study
  • Patients enrolled into the expanded MTD cohort must have shown unequivocal evidence of brain metastases
  • Male and female patients.
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • An expected survival of at least 3 months
  • Measurable disease according to RECIST criteria; patients with brain metastases must have at least one measurable lesion in the brain, according to RECIST criteria
  • Male and female subjects who are not surgically sterile or post-menopausal must agree to use reliable methods of birth control for the duration of the study and for 90 days after the last dose of study drug administration; male partners of female subjects should use condoms for the duration of the study, and for 90 days after the last dose of study drug administration

You may not qualify if:

  • Chemotherapy, radiotherapy (except palliative radiation delivered to \<20% of bone marrow), or investigational agents within 4 weeks before the first dose of study drug. Biologic therapy (such as 13-cis-retinoic acid, thalidomide, tamoxifen, celebrex, erlotinib, imatinib, vorinostat, and lapatinib) and immunotherapy (such as interferon a or b, cdx-110 (EGFR vIII vaccine), interleukin 2, thalidomide) within 1 week before the first dose of study drug. Bevacizumab within 6 weeks before the first dose of study drug
  • Pregnant or lactating females
  • Any acute viral, bacterial, or fungal infection that requires parenteral therapy within 14 days prior to study treatment
  • Known severe hypersensitivity to paclitaxel
  • Severe toxicity with previous taxane treatment
  • Treatment with P450 CYP 3A4 or CYP 2C8 enzyme-inducing anti-convulsant drugs within 14 days prior to treatment with study drug
  • Patients with inadequate hematological, liver, and renal function
  • Known or suspected acute or chronic active Hepatitis B, Hepatitis C, or HIV/AIDS
  • Patients with unstable or uncompensated respiratory, cardiac, hepatic or renal disease or any other organ system dysfunction, medical condition, or laboratory abnormality which, in the opinion of the Investigator, would either comprise the patient's safety or interfere with the evaluation of the test material
  • Evidence of persistent Grade 2 or greater neurotoxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UT Health Science Center, Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Kurzrock R, Gabrail N, Chandhasin C, Moulder S, Smith C, Brenner A, Sankhala K, Mita A, Elian K, Bouchard D, Sarantopoulos J. Safety, pharmacokinetics, and activity of GRN1005, a novel conjugate of angiopep-2, a peptide facilitating brain penetration, and paclitaxel, in patients with advanced solid tumors. Mol Cancer Ther. 2012 Feb;11(2):308-16. doi: 10.1158/1535-7163.MCT-11-0566. Epub 2011 Dec 27.

    PMID: 22203732RESULT

Related Links

MeSH Terms

Conditions

Lung NeoplasmsBreast NeoplasmsMelanomaCarcinoma, HepatocellularBrain Neoplasms

Interventions

paclitaxel-Angiopep-2 conjugate

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLiver NeoplasmsDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 4, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

US(3)