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| Sponsor: | Active Biotech AB |
|---|---|
| Information provided by: | Active Biotech AB |
| ClinicalTrials.gov Identifier: | NCT00056537 |
Purpose
The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug can be given to patients with non-small cell lung cancer, renal clear cell carcinoma, or pancreatic cancer without causing unacceptable side effects.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Carcinoma Renal Cell Carcinoma Pancreatic Cancer |
Drug: ABR-217620 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Phase I, Repeat Dose-Escalation Study of ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer |
| Enrollment: | 44 |
| Study Start Date: | April 2003 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: ABR-217620
Starting dose: 0.5 mcg/kg; subsequent doses: individual, based on pre-treatment level of anti-SEA/E-120, body weight, and toxicities observed in prior patients on study; IV; one bolus injection each day for 5 consecutive days; up to 3 cycles
Other Name: CD3; 5T4FabV18-SEA/E-120; naptumomab estafenatox; Anyara
|
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| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Norway | |
| Det Norske Radiumhospitalet | |
| Oslo, Norway | |
| United Kingdom | |
| Paterson Institute for Cancer Research, Christie Hospital NHS Trust and Research Institute | |
| Manchester, United Kingdom, M20 4BX | |
| Study Director: | Suzanne Kilany | Active Biotech AB |
More Information
| Responsible Party: | Lars M Nilsson, DVM / VP Regulatory & Quality Affairs, Active Biotech Research |
| ClinicalTrials.gov Identifier: | NCT00056537 History of Changes |
| Other Study ID Numbers: | 01762001 |
| Study First Received: | March 16, 2003 |
| Last Updated: | March 5, 2008 |
| Health Authority: | United States: Food and Drug Administration; Norway: Norwegian Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Kidney Neoplasms Lung Neoplasms Pancreatic Neoplasms Adenocarcinoma, Clear Cell Adenomyoepithelioma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Neoplasms, Complex and Mixed |