Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01824901
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2013-04-02
Brief Title:
Docetaxel With or Without FGFR Inhibitor AZD4547 in Treating Patients With Recurrent Non-Small Cell Lung Cancer
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase IRandomized Phase II Study of Docetaxel With or Without AZD4547 in Recurrent FGFR1-Amplified Squamous Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 randomized phase III trial studies the side effects and best dose of fibroblast growth factor receptor FGFR inhibitor AZD4547 when given with docetaxel and to see how well it works in treating patients with recurrent non-small cell lung cancer Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing FGFR inhibitor AZD4547 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It is not yet known whether docetaxel and FGFR inhibitor AZD4547 are more effective when given together or separately
Detailed Description:
PRIMARY OBJECTIVES
I Determination of a recommended phase II dose for the combination of docetaxel and AZD4547 FGFR inhibitor AZD4547 Phase I II Estimation and comparison of progression-free survival PFS of each treatment arm Phase II
SECONDARY OBJECTIVES
I Pharmacokinetic evaluation of docetaxel with or without concomitant AZD4547 Pharmacokinetic evaluation of AZD4547 with concomitant docetaxel Phase I II Safety assessment and toxicity characterization of the combination Phase I III Initial assessment of clinical activity of the combination Phase I IV Response rate Phase II V Overall survival Phase II VI Estimation of response to single agent AZD4547 among patients who crossover from single agent docetaxel Phase II VII Further safety assessment and toxicity characterization of AZD4547 alone and in combination with docetaxel Phase II
OUTLINE This is a phase I dose-escalation study of FGFR inhibitor AZD4547 followed by a randomized phase II study
PHASE I
Patients receive docetaxel intravenously IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 orally PO twice daily BID on days 2-15 of course 1 and days 1-14 of all subsequent courses Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PHASE II STEP I Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive docetaxel IV over 60 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who experience progressive disease may then receive FGFR inhibitor AZD4547 PO BID on days 1-14
ARM II Patients receive docetaxel IV as in Arm I and FGFR inhibitor AZD4547 PO BID on days 1-14
In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PHASE II STEP II
Patients receive FGFR inhibitor AZD4547 PO BID on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 3 years
This study opened to accrual on September 19 2013 and was suspended to accrual on January 29 2014 after each of the first two patients had been registered to the first dose level of the phase I and experienced dose limiting toxicities DLTs during week 1 of cycle 1 The study was subsequently terminated on April 17 2014 after having met the predefined criteria for closure per the phase I study design
I Determination of a recommended phase II dose for the combination of docetaxel and AZD4547 FGFR inhibitor AZD4547 Phase I II Estimation and comparison of progression-free survival PFS of each treatment arm Phase II
SECONDARY OBJECTIVES
I Pharmacokinetic evaluation of docetaxel with or without concomitant AZD4547 Pharmacokinetic evaluation of AZD4547 with concomitant docetaxel Phase I II Safety assessment and toxicity characterization of the combination Phase I III Initial assessment of clinical activity of the combination Phase I IV Response rate Phase II V Overall survival Phase II VI Estimation of response to single agent AZD4547 among patients who crossover from single agent docetaxel Phase II VII Further safety assessment and toxicity characterization of AZD4547 alone and in combination with docetaxel Phase II
OUTLINE This is a phase I dose-escalation study of FGFR inhibitor AZD4547 followed by a randomized phase II study
PHASE I
Patients receive docetaxel intravenously IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 orally PO twice daily BID on days 2-15 of course 1 and days 1-14 of all subsequent courses Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PHASE II STEP I Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive docetaxel IV over 60 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who experience progressive disease may then receive FGFR inhibitor AZD4547 PO BID on days 1-14
ARM II Patients receive docetaxel IV as in Arm I and FGFR inhibitor AZD4547 PO BID on days 1-14
In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
PHASE II STEP II
Patients receive FGFR inhibitor AZD4547 PO BID on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 3 years
This study opened to accrual on September 19 2013 and was suspended to accrual on January 29 2014 after each of the first two patients had been registered to the first dose level of the phase I and experienced dose limiting toxicities DLTs during week 1 of cycle 1 The study was subsequently terminated on April 17 2014 after having met the predefined criteria for closure per the phase I study design
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 |
|---|---|---|---|
| E2512 | OTHER | ECOG-ACRIN Cancer Research Group | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2012-01940 | REGISTRY | None | None |
| U10CA021115 | NIH | None | None |