CDI-CS-002: Oral BAL101553 in Patients with Advanced Solid Tumors
Research type
Research Study
Full title
An open-label Phase 1/2a study of oral BAL101553 in adult patients with advanced solid tumors
IRAS ID
165479
Contact name
Juanita Lopez
Contact email
Sponsor organisation
Basilea Pharmaceutica International Ltd., Allschwil
Eudract number
2014-003371-34
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
Cancer is a condition in which there is a loss of cell growth control, leading to tumour formation. Microtubules form structures within the cell that are required for cells to properly divide. The study drug, BAL101553, disrupts these stuctures and prevents dividing cells from separating. This can cause these cells to die.
This is the first study of the oral formulation of BAL101553 (called a Phase I study) to be conducted in humans. A similar study has been conducted in cancer patients using an intravenous formulation of BAL101553. BAL101553 is being developed by the company Basilea Pharmaceutica International; it is experimental and therefore only available for use in clinical trials.
During each day of a 28-day treatment cycle, BAL101553 will be given in capsule form to adults with advanced or recurrent solid tumors who have failed standard therapy, or for whom no effective standard therapy is available.
The primary goal of the study is to find the highest dose of BAL101553 that can safely be given to humans and to assess what side-effects occur. The study will start by treating patients with a low dose. Once it has been shown that this low dose is well tolerated, new patients will be treated at higher dose levels (this part of the study is called “dose escalation” and will include up to 42 patients). Once the highest, well-tolerated dose is identified, 20 new patients will treated at that dose (this part is called “dose expansion”) to further assess how well BAL101553 is tolerated and its positive and negative effects.
The study will also measure the amount of the drug and its break-down products in the body at different times, which may help us to understand how the drug is working and how effective it might be against cancer.Summary of Results
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfatiYvtk1-2B2gi1K6vKImual9G6VG4-2FeFhNKGHEnJKTVSkXZOkVsCZd2pMrn0IB6BeRZWdtVK-2BNsLzWz3KsQ37RPt6Zc_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL7svClG01iFiurAXrVv9Z12Jnx1gRMcwF0T5MCqrYsK4I7WJowPwFb-2BHy514rXH5b1XW2sHhY8ihQ9uiDDsHyY-2B57ekY82-2Fk0T2LFryyDh7x69CAVj7S5M8mU6d8JCzk29KKBTLITEr2DiLyQ30dfpADZh7v2wafSEflosNo9Ngw-3D-3D&data=05%7C01%7Csurreyborders.rec%40hra.nhs.uk%7C09037f16b7f44763ff8f08dbeb5d0509%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638362556979685065%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=om176oHzXZ4mhsgAOJum25WOBRotn%2BOw3IF%2B5cg%2BdHs%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: No
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected:
If no, explain why you didn't follow it: N/A. Study results have been posted on CT.gov and EudraCT within the due date (within 12 months after the last patient last visit date).
Have participants been informed of the results of the study?: No
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected:
If no, explain why they haven't: N/A For new studies under the CTR, the ICF will include a statement that the study results will be available in lay term.
This study was conducted under the directive and there was no such regulatory requirement.
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfatiYvtk1-2B2gi1K6vKImual9G6VG4-2FeFhNKGHEnJKTVSkXZOkVsCZd2pMrn0IB6BeRZWdtVK-2BNsLzWz3KsQ37RPxzDp_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL7svClG01iFiurAXrVv9Z1LaypKZi0Bw4YW5H3G54IhvGLw4R8rd4PIn1tTwDdCNqUcbIg5l8A-2FkI6WEWPznX8he9gc71hGdBZEclV21ZAIwC2KWyBemRm7GGK99-2FJoPIBaUTnMI61RqoEnI24jtQkezLF2JMKdkqQo2uzkycC8A-3D-3D&data=05%7C01%7Csurreyborders.rec%40hra.nhs.uk%7C09037f16b7f44763ff8f08dbeb5d0509%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638362556979685065%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=oL%2FpkQY22Cc0EvpkJgPoAui26Q2r7YNIA13bpB0awxY%3D&reserved=0
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: Yes
If yes, describe or provide a URL: Tissue sample associated data are reported in the CSR and they are posted on CT.gov and EudraCT.REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/0263
Date of REC Opinion
25 Feb 2015
REC opinion
Favourable Opinion