Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03531320
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2018-04-10
Brief Title:
Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase
Sponsor:
InnoPharmax Inc
Organization:
InnoPharmax Inc
Study Overview
Official Title:
Open-Label Multicenter Study of D07001-Softgel Capsules Oral Gemcitabine Hydrochloride in Subjects With Unresectable Metastatic or Locally Advanced Gastrointestinal GI Cancer in Dose-Escalation Phase and in Subjects With Advanced Biliary Tract Cancer BTC Following Primary Chemotherapy or Combined Chemoradiotherapy CCRT in Dose-Expansion Phase
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
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:
None
Brief Summary:
Part 1 Dose-Escalation Phase Phase 1b The primary objective is to assess the safety and tolerability of increasing doses of D07001 softgel in patients with unresectable locally advanced or metastatic gastrointestinal GI cancer
Part 2 Dose-Expansion Phase Phase 2 The primary objective is to assess the safety and tolerability of D07001 softgel in patients who have achieved stable disease or better following first line chemotherapy or combined chemoradiotherapy CCRT for unresectable metastatic or locally advanced biliary tract cancer BTC
Part 2 Dose-Expansion Phase Phase 2 The primary objective is to assess the safety and tolerability of D07001 softgel in patients who have achieved stable disease or better following first line chemotherapy or combined chemoradiotherapy CCRT for unresectable metastatic or locally advanced biliary tract cancer BTC
Detailed Description:
This open label multicenter study will be conducted in 2 parts a dose-escalation phase Part 1 and a dose-expansion phase Part 2
In both Part 1 and Part 2 eligible patients will be assigned to receive oral D07001-softgel on Days 1 3 5 8 10 12 15 17 and 19 of a 21-day cycle 9 doses per cycle
Part 1 Dose Escalation Phase Phase 1b Part 1 of the study will follow a 33 dose escalation scheme at predefined dose levels There will be sequential cohorts of 3 to 6 patients each with increasing doses of 40 mg 60 mg 80 mg 120 mg and 160 mg per cohort There will be no intra patient dose escalation Cycle 1 21 days is defined as the dose limiting toxicity DLT assessment period
Part 2 Dose Expansion Phase Phase 2 In Part 2 of the study eligible patients will be randomized in a 11 ratio to receive D07001-softgel in an open label manner at 1 of the 2 dose levels selected for expansion Twenty 20 patients will be enrolled to each dose expansion cohort Patients will be treated until withdrawal from treatment due to disease progression according to RECIST v11 withdrawn consent or when another treatment discontinuation criterion is met Patients who are discontinued from study drug for reasons other than disease progression or toxicity in the first 2 cycles of Part 2 will be replaced
In both Part 1 and Part 2 eligible patients will be assigned to receive oral D07001-softgel on Days 1 3 5 8 10 12 15 17 and 19 of a 21-day cycle 9 doses per cycle
Part 1 Dose Escalation Phase Phase 1b Part 1 of the study will follow a 33 dose escalation scheme at predefined dose levels There will be sequential cohorts of 3 to 6 patients each with increasing doses of 40 mg 60 mg 80 mg 120 mg and 160 mg per cohort There will be no intra patient dose escalation Cycle 1 21 days is defined as the dose limiting toxicity DLT assessment period
Part 2 Dose Expansion Phase Phase 2 In Part 2 of the study eligible patients will be randomized in a 11 ratio to receive D07001-softgel in an open label manner at 1 of the 2 dose levels selected for expansion Twenty 20 patients will be enrolled to each dose expansion cohort Patients will be treated until withdrawal from treatment due to disease progression according to RECIST v11 withdrawn consent or when another treatment discontinuation criterion is met Patients who are discontinued from study drug for reasons other than disease progression or toxicity in the first 2 cycles of Part 2 will be replaced
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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