Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-26 @ 6:27 PM
Study NCT ID:
NCT01625156
Status:
COMPLETED
Last Update Posted:
2015-10-20
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tivantinib and Temsirolimus in Treating Patients With Solid Tumors That is Metastatic or Cannot be Removed by Surgery
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 1 Study of ARQ 197 in Combination With Temsirolimus in Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-05
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 tivantinib when given in combination with temsirolimus in treating patients with solid tumors that have spread to other parts of the body or cannot be removed by surgery. Tivantinib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ARQ197 (tivantinib) in combination with temsirolimus in adult subjects with advanced solid tumors who are extensive cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) metabolizers.
SECONDARY OBJECTIVES:
I. To characterize the tolerability and/or MTD of ARQ 197 and in combination with temsirolimus in adult subjects who are poor CYP2C19 metabolizers (CYP2C19\*2/\*2, \*2/\*3 or \*3/\*3 polymorphisms).
II. To identify the pharmacokinetic parameters of ARQ 197 after a single dose and at steady state in extensive and poor CYP2C19 metabolizers.
III. To assess the steady state pharmacokinetics of ARQ 197 alone and in combination with temsirolimus.
IV. To determine impact of cytochrome P450, family 3, subfamily A, polypeptide 4/cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A4/5) polymorphisms on ARQ 197 pharmacokinetic parameters.
V. To determine the pharmacokinetics of temsirolimus and its active metabolite sirolimus in combination with ARQ 197 and compare to historical pharmacokinetic data.
VI. To determine impact of CYP3A4/5 polymorphisms on temsirolimus pharmacokinetic parameters.
VII. To describe the dose-limiting toxicities and determine the safety profile of the combination of ARQ 197 and temsirolimus.
VIII. To evaluate the preliminary anti-tumor activity of ARQ197 and temsirolimus in patients with advanced solid tumors.
IX. To correlate archived tumor tissue expression of c-Met with objective response to ARQ 197 and temsirolimus therapy.
OUTLINE: This is a dose-escalation study of tivantinib.
Patients receive tivantinib orally (PO) twice daily (BID) and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22 (days 8, 15, 22, and 29 of course 1). Courses repeat every 28 days (35 days in course 1) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 4 weeks.
I. To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ARQ197 (tivantinib) in combination with temsirolimus in adult subjects with advanced solid tumors who are extensive cytochrome P450, family 2, subfamily C, polypeptide 19 (CYP2C19) metabolizers.
SECONDARY OBJECTIVES:
I. To characterize the tolerability and/or MTD of ARQ 197 and in combination with temsirolimus in adult subjects who are poor CYP2C19 metabolizers (CYP2C19\*2/\*2, \*2/\*3 or \*3/\*3 polymorphisms).
II. To identify the pharmacokinetic parameters of ARQ 197 after a single dose and at steady state in extensive and poor CYP2C19 metabolizers.
III. To assess the steady state pharmacokinetics of ARQ 197 alone and in combination with temsirolimus.
IV. To determine impact of cytochrome P450, family 3, subfamily A, polypeptide 4/cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A4/5) polymorphisms on ARQ 197 pharmacokinetic parameters.
V. To determine the pharmacokinetics of temsirolimus and its active metabolite sirolimus in combination with ARQ 197 and compare to historical pharmacokinetic data.
VI. To determine impact of CYP3A4/5 polymorphisms on temsirolimus pharmacokinetic parameters.
VII. To describe the dose-limiting toxicities and determine the safety profile of the combination of ARQ 197 and temsirolimus.
VIII. To evaluate the preliminary anti-tumor activity of ARQ197 and temsirolimus in patients with advanced solid tumors.
IX. To correlate archived tumor tissue expression of c-Met with objective response to ARQ 197 and temsirolimus therapy.
OUTLINE: This is a dose-escalation study of tivantinib.
Patients receive tivantinib orally (PO) twice daily (BID) and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22 (days 8, 15, 22, and 29 of course 1). Courses repeat every 28 days (35 days in course 1) 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00949 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| NCI 9145 | None | None | View | |
| 905854-02-06 | None | None | View | |
| NCI-2012-00974 | None | None | View | |
| CO 11914 | OTHER | University of Wisconsin Hospital and Clinics | View | |
| 9145 | OTHER | CTEP | View | |
| P30CA014520 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062491 | NIH | None | https://reporter.nih.gov/quic… | View |