A Phase 1, Open-Label, Dose Escalation Study of ANG1005 in Patients With Malignant Glioma
2 other identifiers
interventional
63
1 country
6
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 recurrent or progressive malignant glioma. 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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2007
Typical duration for phase_1
6 active sites
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
CompletedFirst Submitted
Initial submission to the registry
October 2, 2007
CompletedFirst Posted
Study publicly available on registry
October 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJuly 31, 2014
July 1, 2014
2.4 years
October 2, 2007
July 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To characterize the safety and tolerability of intravenously administered ANG1005 in patients with malignant glioma.
On-going
To identify the maximum tolerated dose (MTD) of ANG1005 in patients with malignant glioma.
End of dose escalation
Secondary Outcomes (5)
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 about the antitumor activity of ANG1005 in patients with malignant glioma.
On-going
To obtain preliminary information about whether or not ANG1005 crosses the blood- brain barrier into malignant glioma tumors (Sub-study).
On-going
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- Histologically confirmed malignant glioma
- Radiologically confirmed progression of malignant glioma
- Patients must, in the opinion of the investigator, be ineligible for current standard of care treatment
- No evidence of acute intracranial/intratumoral hemorrhage
- 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 Macdonald response 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
- Patients being treated 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, or 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
- Angiochem Inclead
Study Sites (6)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Irving Comprehensive Cancer Center, Columbia University Medical Center
New York, New York, 10032, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
UT Health Science Center at the Cancer Therapy and Research Center (CTRC)
San Antonio, Texas, 78229, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Related Publications (1)
Drappatz J, Brenner A, Wong ET, Eichler A, Schiff D, Groves MD, Mikkelsen T, Rosenfeld S, Sarantopoulos J, Meyers CA, Fielding RM, Elian K, Wang X, Lawrence B, Shing M, Kelsey S, Castaigne JP, Wen PY. Phase I study of GRN1005 in recurrent malignant glioma. Clin Cancer Res. 2013 Mar 15;19(6):1567-76. doi: 10.1158/1078-0432.CCR-12-2481. Epub 2013 Jan 24.
PMID: 23349317RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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 2, 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