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AzTrials

Small Cell Lung CarcinomaPhase 1NCT01187615

Determination of Safety, Efficacy, and Pharmacokinetics of "Regorafenib" Combined With Pemetrexed and Cisplatin in Patients With Nonsquamous Non-Small Cell Lung Cancer

A Phase 1 study testing Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed and Regorafenib (BAY73-4506) - continuous / Cisplatin / Pemetrexed in people with Small Cell Lung Carcinoma, run by Bayer at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Carcinoma
What is being tested?
Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed and Regorafenib (BAY73-4506) - continuous / Cisplatin / Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
4 sitesUnited States
Study dates
Aug 2010to Jun 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 18 years.
  • Histological or cytological diagnosis of metastatic Stage IV or locally advanced, unresectable confirmed Stage IIIB nonsquamous Non-Small Cell Lung Cancer (NSCLC) not amenable to local therapy with curative intent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2
  • Life expectancy of at least 12 weeks.
  • Adequate bone marrow, liver, and renal function
  • Controlled blood pressure [defined as systolic Blood Pressure (BP) <=150 mmHg and diastolic Blood Pressure (BP) <= 90 mmHg]
  • Men and women of childbearing potential enrolled in this study must use adequate barrier birth control measures during the course of the study

Who cannot join

  • Sensory neuropathy with sensory alterations or paresthesia (including tingling), interfering with function
  • Hearing impairment
  • Persistent proteinuria of Common Toxicity Criteria (CTC) Grade 3 or higher
  • Cardiac disease: congestive heart failure > New York Heart Association (NYHA) Class II; patients must not have unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Brain metastasis: patients with neurological symptoms should undergo a Computerized Tomography (CT) scan / Magnetic Resonance Imaging (MRI) of the brain to exclude any new or progressive brain metastasis. Patients with brain metastases are excluded from the trial
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication
Show all 13Show fewer
  • Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks prior to the start of study treatment. Clinically significant hemoptysis (1 teaspoon or more) in the past 3 months
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks prior to the start of study treatment
  • Evidence or history of bleeding diathesis or coagulopathy
  • Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels
  • The effect of third space fluid, such as pleural effusion and ascites, on pemetrexed is unknown. In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to study start
  • Patients with phaeochromocytoma Excluded Therapies and Medications, Previous and Concomitant
  • Prior treatment with a systemic chemotherapy for metastatic NSCLC. Patients who underwent prior systemic treatment or radiotherapy for NSCLC in a neoadjuvant or adjuvant setting are eligible, but no chemotherapy treatment within the last 6 month prior to study entry is allowed

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Las Vegas, Nevada, 89135-3011

  • Study site

    New Haven, Connecticut, 06519

  • Study site

    New York, New York, 10065

Other trials in United States

About this study

Official title: 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

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.

Being tested
Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed, Regorafenib (BAY73-4506) - continuous / Cisplatin / Pemetrexed
Keywords
Nonsquamous Non-small cell lung cancer, Phase I
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regorafenib (BAY73-4506) - sequential / Cisplatin / PemetrexedDrug

    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. Pharmacokinetics of regorafenib will be assessed on Day 14 of Cycle 1 and Day 1 of Cycle 2.

  • Regorafenib (BAY73-4506) - continuous / Cisplatin / PemetrexedDrug

    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. Pharmacokinetics of regorafenib will be assessed on Day 21 of Cycle 1 and on Day 1 of Cycle 2.

Study groups in NCT01187615
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed
Arm 2ExperimentalNot described
Receives: Drug: Regorafenib (BAY73-4506) - continuous / Cisplatin / Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment related toxicities and adverse events and change from baseline in vitals signs and laboratory parameters

    Measured: 3 years (depending on the treatment duration of individual patients)

  2. Pharmacokinetics assessments of Alimta, Cisplatin, and regorafenib in Cycle 1 and 2

    Measured: end of cycle 2

Secondary outcomes (2)

  1. Biomarkers (includes but not limited to plasma protein analysis of angiogenesis-related proteins, DNA mutational anaylsis of tumor tissue and plasma)

    Measured: 3 years (depending on the treatment duration of individual patients)

  2. Tumor Assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) every second cycle

    Measured: 3 years (depending on the treatment duration of individual patients)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01187615
Sponsor's protocol ID
14458
Status last verified
Jul 2014
First submitted
16 Jul 2010
Last updated
8 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • Hellmann MD, Sturm I, Trnkova ZJ, Lettieri J, Diefenbach K, Rizvi NA, Gettinger SN. Preliminary Safety, Pharmacokinetics, and Efficacy of Regorafenib, Cisplatin, and Pemetrexed in Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancers. Clin Lung Cancer. 2015 Nov;16(6):514-22. doi: 10.1016/j.cllc.2015.04.003. Epub 2015 Apr 20.

    PubMed 26003007

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed and Regorafenib (BAY73-4506) - continuous / Cisplatin / Pemetrexed in people with Small Cell Lung Carcinoma, run by Bayer at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment related toxicities and adverse events and change from baseline in vitals signs and laboratory parameters (time frame: 3 years (depending on the treatment duration of individual patients)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01187615, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.

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