- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01357395
A Phase 2, Open-Label Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer (ESCAPE)
October 20, 2017 updated by: Astex Pharmaceuticals, Inc.
A Phase 2, Open-Label, Multi-Center Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer Subjects Who Have Not Responded to Standard Treatment or Relapsed After Standard Treatment
The purpose of the study is to evaluate the safety and potential benefit of combination amuvatinib with standard of care chemotherapy treatment (platinum and etoposide) in small cell lung cancer (SCLC) subjects.
Study Overview
Detailed Description
Amuvatinib is an oral multi-targeted tyrosine kinase inhibitor which inhibits the mutant forms of c-Kit and PDGFR alpha.
It also disrupts DNA repair likely through suppression of Homologous Recombination protein Rad51.
In a Phase 1b clinical study in combination with VP-16 and carboplatin, responses in SCLC were observed.
In vitro and in vivo data demonstrated amuvatinib synergy with VP-16 thereby further supporting this combination for continued evaluation in clinical trials.
Pharmacokinetic data from Phase 1 clinical trials suggest that co-administration of amuvatinib did not alter exposures of standard of care agents VP-16 or carboplatin as measured by overall exposure.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mazowieckie
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Radom, Mazowieckie, Poland, 26-617
- Wojewodzki Szpital Specjalistyczny
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Warszawa, Mazowieckie, Poland, 02-781
- Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
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Podkarpackie
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Przemyśl, Podkarpackie, Poland, 37-700
- Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
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Pomorskie
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Gdansk, Pomorskie, Poland, 80-219
- Wojewodzkie Centrum Onkologii
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Zachodniopomorskie
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Szczecin, Zachodniopomorskie, Poland, 70-891
- Specjalistyczny Szpital im. Alfreda Sokolowskiego
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute of Emory University
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Kentucky
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Louisville, Kentucky, United States, 40202
- James Graham Brown Cancer Center, University of Louisville
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Missouri
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Saint Louis, Missouri, United States, 63108
- Washington University School of Medicine
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Associates in Oncology and Hematology
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Nashville, Tennessee, United States, 37232
- Vanderbilt - Ingram Cancer Center
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female ≥ 18 of age at the time of consent and have histologically or cytologically confirmed SCLC
Measurable SCLC per RECIST guideline that meets one of the following:
- Disease progression by RECIST at anytime during platinum-etoposide (PE) chemotherapy;
- Relapse by RECIST within 90 days after completing PE chemotherapy;
- Stable disease by RECIST as best response after at least two (2) ≥ 21-day cycles of PE chemotherapy. The assessment of stable disease should be made at least 2 weeks after the start of the second cycle
Subjects who received another second-line therapy are eligible if they still fulfill any one of the above three conditions, and all other eligibility criteria
- Start treatment with the same last regimen (dose and schedule) of first-line PE chemotherapy that they progressed or relapsed on, including any dose reductions because of toxicity, prior to study entry
- ECOG performance status 0 to 2
- Adequate organ function
- Subjects with screening 12-lead ECG with measurable QTc interval of < 450 msec. If QTc ≥ 450 msec, then confirm the reading by evaluating the mean QTc interval of triplicate ECGs.
- Sign approved informed consent form
Exclusion Criteria:
- Prior exposure to amuvatinib
- No longer eligible for first-line PE chemotherapy due to toxicity and the Investigator believes that the risk of retreating with the same PE chemotherapy regimen would outweigh the benefit
- Ongoing toxicity from prior treatment unless the toxicity has resolved, or in the opinion of the Investigator, is stable and does not compromise the safety of the subject
- Mixed SCLC and non-small cell lung cancer, or large cell lung cancer
- Untreated, unstable, or symptomatic brain metastasis
- Hypersensitivity to amuvatinib, excipients of amuvatinib, or any agent given in association with this trial
- A life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or interfere with study outcomes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Amuvatinib
Amuvatinib 300 mg PO TID + standard-of-care platinum-etoposide
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Amuvatinib 300 mg PO TID
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Overall objective response rate (CR or PR)
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Duration of response
Time Frame: 6 months
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6 months
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Safety and tolerability
Time Frame: 6 months
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6 months
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Disease control rate
Time Frame: 6 months
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6 months
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Progression-free survival and overall survival
Time Frame: 6 months
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6 months
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Amuvatinib and metabolites PK and other biomarkers
Time Frame: 6 months
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6 months
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Amuvatinib PK interactions with platinum-etoposide chemotherapy
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 28, 2012
Study Registration Dates
First Submitted
May 17, 2011
First Submitted That Met QC Criteria
May 18, 2011
First Posted (Estimate)
May 20, 2011
Study Record Updates
Last Update Posted (Actual)
October 24, 2017
Last Update Submitted That Met QC Criteria
October 20, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGI-0470-07
- 2010-024378-21 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Amuvatinib
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Astex Pharmaceuticals, Inc.Completed