stop_circleTerminated/Withdrawn

Small Cell Lung Carcinoma

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
9
Trial Dates
August 2010 - June 2012
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Yale Cancer CenterNew Haven, 06519, United States
Completed
Memorial Sloan-Kettering Cancer CenterNew York, 10065, United States
Terminated
Nevada Cancer InstituteLas Vegas, 89135-3011, United States
Terminated
University of North Carolina HospitalsChapel 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 parameters
    date_rangeTime Frame:
    3 years (depending on the treatment duration of individual patients)
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    Safety Issue:
    Yes
  • Pharmacokinetics assessments of Alimta, Cisplatin, and regorafenib in Cycle 1 and 2
    date_rangeTime Frame:
    end of cycle 2
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    Safety Issue:
    No

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)
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    Safety Issue:
    No
  • Tumor Assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) every second cycle
    date_rangeTime Frame:
    3 years (depending on the treatment duration of individual patients)
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    Safety Issue:
    No

Trial design

An Open-label, multi-center, non-randomized Phase Ib study to Investigate the Safety, Efficacy, and Pharmacokinetics of BAY 73-4506 “Regorafenib”, administered in combination with Pemetrexed and Cisplatin in patients with Advanced Nonsquamous Non-Small Cell Lung Cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
2