A Phase 1, Open-Label, Dose Escalation Study of ANG1005 in Patients With Advanced Solid Tumors and Metastatic Brain Cancer
NCT ID: NCT00539383
Last Updated: 2014-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2007-10-31
2010-03-31
Brief Summary
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Detailed Description
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Initially, cohorts of 1 - 3 patients will be enrolled into each dose group. Dose escalation by dose doubling will be done for the first 3 dose groups followed by a modified Fibonacci dose escalation scheme with increases of 67%, 50%, 40% and 33% thereafter. If 1 or more patients in a cohort experience an emergent ≥ Grade 2 drug-related toxicity during the first treatment cycle, then a minimum of 3 patients will be enrolled into that, and all subsequent cohort(s) and dose doubling will be stopped if applicable.
If \> 1 patient in a cohort experience a dose limiting toxicity (DLT) during the first treatment cycle, defined as any of the following that are both treatment-emergent and at least possibly related to ANG1005: i) Any Grade 3 or 4 nonhematologic toxicity, ii) Febrile neutropenia, iii) Grade 4 neutropenia of ≥7 days duration, and/or iv) Any Grade 4 thrombocytopenia, then dose escalation will stop and prior doses will be explored as the maximum tolerated dose (MTD), that dose-level at which ≤1 of 6 patients in a cohort develop an emergent DLT).
Once the MTD is established, approximately 14 patients will be enrolled at that dose-level in order to further assess the safety and tolerability of ANG1005, the PK profile of ANG1005 at the MTD, and the preliminary anti-tumor activity of ANG1005 in patients with solid tumors (with or without brain metastases).
Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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1
ANG1005
IV infusion once every 21 days
Interventions
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ANG1005
IV infusion once every 21 days
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Patients enrolled into the expanded MTD cohort must have shown unequivocal evidence of brain metastases
4. Male and female patients.
5. Age ≥18 years
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
7. An expected survival of at least 3 months
8. Measurable disease according to RECIST criteria; patients with brain metastases must have at least one measurable lesion in the brain, according to RECIST criteria
9. 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
Exclusion Criteria
2. Pregnant or lactating females
3. Any acute viral, bacterial, or fungal infection that requires parenteral therapy within 14 days prior to study treatment
4. Known severe hypersensitivity to paclitaxel
5. Severe toxicity with previous taxane treatment
6. Treatment with P450 CYP 3A4 or CYP 2C8 enzyme-inducing anti-convulsant drugs within 14 days prior to treatment with study drug
7. Patients with inadequate hematological, liver, and renal function
8. Known or suspected acute or chronic active Hepatitis B, Hepatitis C, or HIV/AIDS
9. 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
10. Evidence of persistent Grade 2 or greater neurotoxicity
18 Years
ALL
No
Sponsors
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Angiochem Inc
INDUSTRY
Responsible Party
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Angiochem Inc.
Locations
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Gabrail Cancer Center
Canton, Ohio, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
UT Health Science Center, Cancer Therapy and Research Center
San Antonio, Texas, United States
Countries
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References
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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.
Other Identifiers
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FDA
Identifier Type: -
Identifier Source: secondary_id
ANG1005-CLN-02
Identifier Type: -
Identifier Source: org_study_id
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