Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652206
Status:
UNKNOWN
Last Update Posted:
2021-12-29
First Post:
2020-11-20
Brief Title:
Clinical Trial to Investigate Safety Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients
Sponsor:
Scandion Oncology AS
Organization:
Scandion Oncology AS
Study Overview
Official Title:
An Open-label Phase Ib Prospective Clinical Trial to Investigate Safety Tolerability and Maximum Tolerated Dose for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANTAX-Ib
Brief Summary:
An open-label dose escalating phase Ib study of SCO-101 in combination with gemcitabine and nab-paclitaxel The primary objectives are to establish the safety profile and the MTD of SCO-101 when combined with gemcitabine and nab-paclitaxel The starting dose of SCO-101 is 150 mg and the dose may be increased to a maximum of 350 mg
Detailed Description:
The study is an open-label dose escalating phase Ib study of SCO-101 in combination with gemcitabine and nab-paclitaxel The primary objective is to establish the safety tolerability and MTD of SCO-101 when combined with gemcitabine and nab-paclitaxel Secondary objectives are efficacy and to establish PK parameters of SCO-101 The target indication is patients with inoperal pancreatic cancer who are to be treated with gemcitabine and nab-paclitaxel The study is designed as a standard 33 dose escalation study with increasing doses of SCO-101 and a fixed dose standard regimen of gemcitabine and nab-paclitaxel An interim report will be prepared once the last patient in the MTD cohort has completed one treatment cycle Patients will continue treatment until disease progression to evaluate secondary objectives One treatment Cycle is 28 days The starting dose of SCO-101 is 150 mg 6 daily dosing in a bi-weekly schedule and may be increased to a maximum of 350 mg 5 cohorts with 50 mg increments A total of up to 18 patients are anticipated if dose escalation to the 5th cohort Gemcitabine and nab-paclitaxel is administered according to local standard recommendations once weekly for three weeks followed by one weeks treatment holiday dosing on day 6 day 13 and day 20 Patients may continue treatment until treatment progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002627-11 | EUDRACT_NUMBER | None | None |