stop_circleTerminated/Withdrawn
Small Cell Lung Carcinoma
Bayer Identifier:
14458
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Determination of safety, efficacy, and pharmacokinetics of "Regorafenib" combined with Pemetrexed and Cisplatin in patients with Nonsquamous Non-Small Cell Lung Cancer
Trial purpose
This is a multi-center, open-label, non-randomized Phase I study to define the safety profile, maximum tolerated dose (MTD) and potential pharmacokinetic interaction of regorafenib in combination with pemetrexed and cisplatin in patients with Stage IIIB or Stage IV nonsquamous Non-Small Cell Lung Cancer (NSCLC) and to determine the impact of the combined administration on the pharmacokinetics of regorafenib, pemetrexed, and cisplatin.
In Part A of this trial, regorafenib will be administered in a sequential dosing with a seven day wash out period before the next infusion of pemetrexed and cisplatin. Regorafenib will be administered at a dose of 160 mg qd from Day 2 to Day 14 followed by a 7 days break.
In Part B of this trial, regorafenib will be administered continuously from Day 1 to Day 21. Only in Cycle 1, regorafenib dosing will start on Day 2 in order to assess the pharmacokinetics of pemetrexed and cisplatin without concomitant regorafenib dosing.
In Part A of this trial, regorafenib will be administered in a sequential dosing with a seven day wash out period before the next infusion of pemetrexed and cisplatin. Regorafenib will be administered at a dose of 160 mg qd from Day 2 to Day 14 followed by a 7 days break.
In Part B of this trial, regorafenib will be administered continuously from Day 1 to Day 21. Only in Cycle 1, regorafenib dosing will start on Day 2 in order to assess the pharmacokinetics of pemetrexed and cisplatin without concomitant regorafenib dosing.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
9Trial Dates
August 2010 - June 2012Phase
Phase 1Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Yale Cancer Center | New Haven, 06519, United States |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Terminated | Nevada Cancer Institute | Las Vegas, 89135-3011, United States |
Terminated | University of North Carolina Hospitals | Chapel Hill, 27599, United States |
Primary Outcome
- Number of participants with treatment related toxicities and adverse events and change from baseline in vitals signs and laboratory parametersdate_rangeTime Frame:3 years (depending on the treatment duration of individual patients)enhanced_encryptionYesSafety Issue:
- Pharmacokinetics assessments of Alimta, Cisplatin, and regorafenib in Cycle 1 and 2date_rangeTime Frame:end of cycle 2enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Biomarkers (includes but not limited to plasma protein analysis of angiogenesis-related proteins, DNA mutational anaylsis of tumor tissue and plasma)date_rangeTime Frame:3 years (depending on the treatment duration of individual patients)enhanced_encryptionNoSafety Issue:
- Tumor Assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) every second cycledate_rangeTime Frame:3 years (depending on the treatment duration of individual patients)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
2