Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05651269
Status:
UNKNOWN
Last Update Posted:
2022-12-15
First Post:
2022-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Milciclib in Combination With Gemcitabine in Advanced NSCLC
Sponsor:
Tiziana Life Sciences LTD
Organization:
Study Overview
Official Title:
Milciclib in Combination With Gemcitabine in Advanced Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this interventional clinical study is to evaluate the safety and efficacy of Milciclib plus gemcitabine in the treatment of persons with advanced NSCLC. This is an open label uncontrolled clinical trial
Eligible patients will receive 150 mg/day of milciclib orally using the 7 days on/7 days off schedule in combination with gemcitabine at the dose of 1000 mg/m² on Days 1, 8, and 15 every 4 weeks. Treatment cycles will be repeated every 4 weeks until progressive disease (radiologic or symptomatic deterioration), the start of a new systemic anticancer therapy, unacceptable toxicity, withdrawal per investigator's judgment, or withdrawal of consent, whichever occurs first.
Eligible patients will receive 150 mg/day of milciclib orally using the 7 days on/7 days off schedule in combination with gemcitabine at the dose of 1000 mg/m² on Days 1, 8, and 15 every 4 weeks. Treatment cycles will be repeated every 4 weeks until progressive disease (radiologic or symptomatic deterioration), the start of a new systemic anticancer therapy, unacceptable toxicity, withdrawal per investigator's judgment, or withdrawal of consent, whichever occurs first.
Detailed Description:
This study is a multicenter, prospective, non-randomized, open-label, single-arm Phase 2 study in locally advanced non-resectable recurrent and/or metastatic KRAS-mutated NSCLC after failure of at least 1 line of SoC therapy.
All patients will be screened for KRAS mutation status. A total of up to 28 patients harboring G12A, G12D, G12F, G12R, G12S, G12V, or G13D KRAS mutations, or, any pathogenic KRAS mutation other than G12C mutations will be enrolled and treated. According to the Simon's 2-stage design, 13 patients will be treated at Stage 1 with up to 15 patients treated at Stage 2.
At the completion of Stage 1, a review of the tumor response evaluation will be undertaken to determine if the second stage should be conducted. If there are 2 or more patients with a complete response (CR) or partial response (PR) in the first 13 patients, an additional 15 patients will be accrued.
Stage 1 will be considered complete when all patients have experienced progressive disease (radiologic or symptomatic deterioration), started a new systemic anticancer therapy, have withdrawn per investigator's judgment or experienced unacceptable toxicity, have withdrawn consent, or have completed 6 cycles of treatment.
In addition, Stage 1 patients who, at the time of transition to Stage 2, were responding with a CR, PR, or stable disease, will be allowed to continue in the study at the recommended Phase 2 dose; or lower for safety reasons). These patients will not be part of the 15 new patients to be targeted in Stage 2, because they will have already received treatment with milciclib plus gemcitabine in Stage 1, but they will provide additional safety information regarding prolonged treatment with milciclib plus gemcitabine
All patients will be screened for KRAS mutation status. A total of up to 28 patients harboring G12A, G12D, G12F, G12R, G12S, G12V, or G13D KRAS mutations, or, any pathogenic KRAS mutation other than G12C mutations will be enrolled and treated. According to the Simon's 2-stage design, 13 patients will be treated at Stage 1 with up to 15 patients treated at Stage 2.
At the completion of Stage 1, a review of the tumor response evaluation will be undertaken to determine if the second stage should be conducted. If there are 2 or more patients with a complete response (CR) or partial response (PR) in the first 13 patients, an additional 15 patients will be accrued.
Stage 1 will be considered complete when all patients have experienced progressive disease (radiologic or symptomatic deterioration), started a new systemic anticancer therapy, have withdrawn per investigator's judgment or experienced unacceptable toxicity, have withdrawn consent, or have completed 6 cycles of treatment.
In addition, Stage 1 patients who, at the time of transition to Stage 2, were responding with a CR, PR, or stable disease, will be allowed to continue in the study at the recommended Phase 2 dose; or lower for safety reasons). These patients will not be part of the 15 new patients to be targeted in Stage 2, because they will have already received treatment with milciclib plus gemcitabine in Stage 1, but they will provide additional safety information regarding prolonged treatment with milciclib plus gemcitabine
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?: