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| Sponsored by: |
Angiochem Inc |
|---|---|
| Information provided by: | Angiochem Inc |
| ClinicalTrials.gov Identifier: | NCT00539383 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors With and Without Brain Metastases |
Drug: ANG1005 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1, Open-Label, Dose Escalation Study of ANG1005 in Patients With Advanced Solid Tumors and Metastatic Brain Cancer |
| Estimated Enrollment: | 56 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: ANG1005
IV infusion once every 21 days
|
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. Patients may receive additional cycles of ANG1005 if 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.
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Paula Bento | 1-877-322-6446 | pbento@angiochem.com |
| United States, Michigan | |
| Henry Ford Health System | Active, not recruiting |
| Detroit, Michigan, United States, 48202 | |
| United States, Ohio | |
| Gabrail Cancer Center | Recruiting |
| Canton, Ohio, United States, 44718 | |
| Contact: Carrie Smith, RN 330-492-3345 ext 208 csmith@gabrailcancercenter.com | |
| Principal Investigator: Nashat Gabrail, MD | |
| United States, Texas | |
| University of Texas, MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Zhong Guo 713-792-1870 zhongguo@mdanderson.org | |
| Principal Investigator: Razelle Kurzrock, MD | |
| UT Health Science Center, Cancer Therapy and Research Center | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Cherie J. Noles, CCRP 210-450-5964 nolesc@uthscsa.edu | |
| Principal Investigator: John Sarantopoulos, MD | |
More Information
| Responsible Party: | Angiochem Inc. ( Jean-Paul Castaigne, MD - President & CEO ) |
| Study ID Numbers: | ANG1005-CLN-02, FDA |
| Study First Received: | October 3, 2007 |
| Last Updated: | December 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00539383 |
| Health Authority: | United States: Food and Drug Administration |
|
Lung cancer Breast cancer Melanoma Hepatocellular carcinoma Brain metastases |
|
Brain Neoplasms Carcinoma, Hepatocellular Lung Neoplasms Neoplasm Metastasis Central Nervous System Diseases Breast Neoplasms |
Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms Hepatocellular carcinoma Carcinoma Melanoma |
|
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Nervous System Diseases |
