Ignite Creation Date:
2024-05-06 @ 3:10 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02227940
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2014-08-26
Brief Title:
Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I Study of Ceritinib LDK378 a Novel ALK Inhibitor in Combination With Gemcitabine-Based Chemotherapy in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-07
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:
This phase I trial studies the side effects and best dose of ceritinib and combination chemotherapy in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment advanced or pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes locally advanced or has spread to other places in the body metastatic Ceritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as gemcitabine hydrochloride paclitaxel albumin-stabilized nanoparticle formulation and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving ceritinib and more than one drug combination chemotherapy may be a better treatment for solid tumors or pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD and recommended Phase II dose RP2D of ceritinib in combination with gemcitabine gemcitabine hydrochloride alone gemcitabinenab-paclitaxel paclitaxel albumin-stabilized nanoparticle formulation and gemcitabinecisplatin in patients with advanced solid malignancies
SECONDARY OBJECTIVES
I Characterize the safety profile of ceritinib in combination with gemcitabine based chemotherapy in advanced solid malignancies
II Determine the pharmacokinetic profile of ceritinib gemcitabine nab-paclitaxel cisplatin and their metabolites when administered in combination in patients with advanced solid tumors
III Determine the preliminary efficacy of the study combinations
TERTIARY OBJECTIVES
I Explore potential biomarkers of efficacy to the study combination
OUTLINE This is a dose-escalation study of ceritinib Patients are assigned to 1 of 3 treatment arms
ARM 1 ceritinib MTD then with gemcitabine alone
Dose Escalation Cohort 1 Patients with advanced solid tumors for whom gemcitabine hydrochloride-based therapy is clinically appropriate receive ceritinib orally PO once daily QD on days 1-28 and gemcitabine hydrochloride intravenously IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Expansion Cohort 1E Once the MTD of ceritinib has been determined an additional 10 patients with anaplastic lymphoma kinase positive ALK-positive advanced solid tumors who previously progressed on gemcitabine hydrochloride-based therapy receive ceritinib and gemcitabine hydrochloride as in the dose escalation cohort 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM 2 ceritinib MTD then with gemcitabine and nab-paclitaxel
Dose Escalation Cohort 2 Patients with advanced pancreatic cancer receive ceritinib PO QD on days 1-28 gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Expansion Cohort 2E Once the MTD of ceritinib has been determined patients with ALK-positive advanced solid tumors receive ceritinib gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation as in the dose escalation cohort 2 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM 3 ceritinib MTD then with gemcitabine and cisplatin
Dose Escalation Cohort 3 Patients with advanced solid tumors for whom gemcitabine hydrochloride and cisplatin-based therapy is clinically appropriate receive ceritinib PO QD on days 1-28 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Expansion Cohort 3E Once the MTD of ceritinib has been determined an additional 10 patients with ALK-positive advanced solid tumors receive ceritinib gemcitabine hydrochloride and cisplatin as in the dose escalation cohort 3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for at least 4 weeks
I Determine the maximum tolerated dose MTD and recommended Phase II dose RP2D of ceritinib in combination with gemcitabine gemcitabine hydrochloride alone gemcitabinenab-paclitaxel paclitaxel albumin-stabilized nanoparticle formulation and gemcitabinecisplatin in patients with advanced solid malignancies
SECONDARY OBJECTIVES
I Characterize the safety profile of ceritinib in combination with gemcitabine based chemotherapy in advanced solid malignancies
II Determine the pharmacokinetic profile of ceritinib gemcitabine nab-paclitaxel cisplatin and their metabolites when administered in combination in patients with advanced solid tumors
III Determine the preliminary efficacy of the study combinations
TERTIARY OBJECTIVES
I Explore potential biomarkers of efficacy to the study combination
OUTLINE This is a dose-escalation study of ceritinib Patients are assigned to 1 of 3 treatment arms
ARM 1 ceritinib MTD then with gemcitabine alone
Dose Escalation Cohort 1 Patients with advanced solid tumors for whom gemcitabine hydrochloride-based therapy is clinically appropriate receive ceritinib orally PO once daily QD on days 1-28 and gemcitabine hydrochloride intravenously IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Expansion Cohort 1E Once the MTD of ceritinib has been determined an additional 10 patients with anaplastic lymphoma kinase positive ALK-positive advanced solid tumors who previously progressed on gemcitabine hydrochloride-based therapy receive ceritinib and gemcitabine hydrochloride as in the dose escalation cohort 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM 2 ceritinib MTD then with gemcitabine and nab-paclitaxel
Dose Escalation Cohort 2 Patients with advanced pancreatic cancer receive ceritinib PO QD on days 1-28 gemcitabine hydrochloride IV over 30 minutes on days 1 8 and 15 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Expansion Cohort 2E Once the MTD of ceritinib has been determined patients with ALK-positive advanced solid tumors receive ceritinib gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation as in the dose escalation cohort 2 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM 3 ceritinib MTD then with gemcitabine and cisplatin
Dose Escalation Cohort 3 Patients with advanced solid tumors for whom gemcitabine hydrochloride and cisplatin-based therapy is clinically appropriate receive ceritinib PO QD on days 1-28 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Expansion Cohort 3E Once the MTD of ceritinib has been determined an additional 10 patients with ALK-positive advanced solid tumors receive ceritinib gemcitabine hydrochloride and cisplatin as in the dose escalation cohort 3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for at least 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| I 248813 | OTHER | Roswell Park Cancer Institute | None |
| NCI-2014-01766 | REGISTRY | None | None |