Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455052
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2007-04-01
Brief Title:
A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
Sponsor:
Mersana Therapeutics
Organization:
Mersana Therapeutics
Study Overview
Official Title:
A Phase 1 Study of the Safety Tolerability and Pharmacokinetics of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2017-01
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 amended expansion phase of the protocol is to further the experience at a dose level of 150 mg CPT eqm2 in patients with Stage IV non-small cell lung cancer NSCLC and small cell lung cancer SCLC and to test for preliminary anti-tumor activity in these tumor types The MTD was initially defined as 113 mg CPT equivalentseqm2 in the dose escalation part of the study However in the initial expansion phase Protocol Amendment 11 11 patients 10 NSCLC patients and 1 gastric cancer patients were dosed at 113 mg CPT eqm2 and less bone marrow toxicity was observed as compared to more heavily pre-treated patients in the dose escalation part of the study Therefore this amended expansion phase will investigate the safety and anti-tumor effects of a dose of 150 mg CPT eqm2
The study will also determine
The safety and tolerability of XMT-1001 at 150 mg CPT eqm2
The pharmacokinetics PK of XMT-1001 how XMT-1001 behaves in the body in patients Stage IV non-small cell lung carcinoma NSCLC and small cell lung cancer
Evidence of XMT-1001 anti-tumor activity at 150 mg CPT eqm2
The study will also determine
The safety and tolerability of XMT-1001 at 150 mg CPT eqm2
The pharmacokinetics PK of XMT-1001 how XMT-1001 behaves in the body in patients Stage IV non-small cell lung carcinoma NSCLC and small cell lung cancer
Evidence of XMT-1001 anti-tumor activity at 150 mg CPT eqm2
Detailed Description:
This is an open-label study of XMT-1001 administered intravenously over 4 hours every 21 days 1 Cycle Blood sampling for PK analyses will be performed immediately prior to dosing and 9 times after dosing Patients will be assessed for toxicities known to occur with other drugs of this class such as bone marrow suppression elevated liver function enzymes hemorrhagic cystitis and diarrhea Tumor imaging will be performed every 2 cycles
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