An open, randomised phase I/II dose escalation study evaluating the safety and tolerability, pharmacokinetics, antigenicity and efficacy of Iodine-131-Kab201 when given intra-arterially or intravenously in patients with surgically unresectable pancreatic ductal adenocarcinoma
| ISRCTN | ISRCTN16857581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16857581 |
| Secondary identifying numbers | KSB303PAN/C1/001 |
- Submission date
- 12/09/2005
- Registration date
- 19/10/2005
- Last edited
- 10/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof John Neoptolemos
Scientific
Scientific
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
| Phone | +44 (0)151 706 4175 |
|---|---|
| j.p.neoptolemos@liverpool.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | KaBI |
| Study objectives | To assess the safety, tolerability and efficacy of targeted radiotherapy to pancreas using anti-carcinoembryonic antigen (CEA) monoclonal antibody labelled with Iodine-131. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pancreatic adenocarcinoma unsuitable for curative resection. |
| Intervention | Iodine-131-Kab201 given intra-arterially or intravenously |
| Intervention type | Other |
| Primary outcome measure | To evaluate the safety, tolerability and maximum tolerated dose of Iodine-131-Kab201 when administered either intra-arterially or intravenously in patients with unresectable pancreatic cancer. |
| Secondary outcome measures | To assess the pharmacokinetics, antigenicity and evaluate efficacy of Iodine-131-Kab201 when administered either intra-arterially or intravenously in patients with unresectable pancreatic cancer. |
| Overall study start date | 01/09/2002 |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 6 to 48 |
| Key inclusion criteria | 1. Male or female; aged 18 or over 2. Histologically proven diagnosis of ductal adenocarcinoma in the head of the pancreas 3. Advanced pancreatic ductal adenocarcinoma involving the head of the pancreas and thus unsuitable for potentially curative resection 4. At least one confirmed and measurable tumour site on computed tomography (CT) documented within 4 weeks of randomisation 5. Karnofsky Score of 70 or more 6. Life expectancy of greater than or equal to 3 months 7. Women of childbearing potential must have a negative pregnancy test at the time of screening and must be willing to practice appropriate contraceptive methods for the duration of the study. Men with partners of childbearing potential must also be willing to practice appropriate barrier contraceptive methods for the duration of the study. 8. Written informed consent to participate in the study |
| Key exclusion criteria | 1. Leucopenia and/or granulocytopenia 2. Thrombocytopenia 3. Significant and worsening hepatic impairment (aspartate aminotransferase/alanine aminotransferase [AST/ALT] >3 x the upper limit of normal [ULN]; bilirubin >5 x ULN) in the absence of obstructive jaundice. Liver function tests must be stable or improving at time of investigational drug administration. 4. Significant renal impairment (serum creatinine >ULN) 5. Known immunological reactions to previously administered antibodies, proteins or iodine 6. Pregnant or lactating women 7. Radiotherapy or chemotherapy within the preceding 1 month at the scheduled time of dosimetric dosing (preceding 6 weeks for nitrosoureas) 8. Previous external beam radiotherapy to maximal tolerable levels to any critical organ (3000 cGy for liver, 2000 cGY for lungs/kidneys) 9. Treatment with any other clinical trial medication within the 3 months prior to dosimetric dosing 10. Presence of concomitant condition or circumstances which, in the opinion of the investigator, would render the patient unsuitable for the study, such as ongoing alcohol or drug abuse or being unable to tolerate any of the study procedures (e.g. unable to lie flat for nuclear imaging scans) |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 31/10/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom
L7 8XP
United Kingdom
Sponsor information
Xenova Ltd (UK)
Industry
Industry
957 Buckingham Avenue
Slough, Berkshire
SL1 4NL
United Kingdom
| Website | http://www.xenova.co.uk |
|---|
Funders
Funder type
Industry
Xenova Ltd
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results: | 21/07/2006 | Yes | No |
