Small Cell Lung CarcinomaPhase 2ESCAPENCT01357395
A Phase 2, Open-Label Study of Amuvatinib in Combination With Platinum-Etoposide Chemotherapy in Small Cell Lung Cancer
A Phase 2 study testing Amuvatinib in people with Small Cell Lung Carcinoma, run by Astex Pharmaceuticals, Inc. at 12 sites in 2 countries.
Trial summary
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. 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?
- Amuvatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 12 sitesin 2 countries
- Study dates
- May 2011to 28 May 2012
- Phase
- Phase 2
- 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
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States7 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
Associates in Oncology and Hematology
Chattanooga, Tennessee, 37404
MD Anderson Cancer Center
Houston, Texas, 77030
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, 40202
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232
Washington University School of Medicine
St Louis, Missouri, 63108
Poland5 sites
Wojewódzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, 80-219
Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Przemyśl, Podkarpackie Voivodeship, 37-700
Wojewódzki Szpital Specjalistyczny
Radom, Masovian Voivodeship, 26-617
Specjalistyczny Szpital im. Alfreda Sokolowskiego
Szczecin, West Pomeranian Voivodeship, 70-891
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
Warsaw, Masovian Voivodeship, 02-781
About this study
Official title: 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.
Read the 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.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Amuvatinib
- Keywords
- Small Cell Lung Carcinoma
- 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.
AmuvatinibDrug
Also called MP-470
Amuvatinib 300 mg PO TID
| Study group | Role | What they receive |
|---|---|---|
| Amuvatinib | Experimental | Amuvatinib 300 mg PO TID + standard-of-care platinum-etoposide Receives: Drug: Amuvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall objective response rate (CR or PR)
Measured: 3 months
Secondary outcomes (6)
Progression-free survival and overall survival
Measured: 6 months
Disease control rate
Measured: 6 months
Duration of response
Measured: 6 months
Safety and tolerability
Measured: 6 months
Amuvatinib and metabolites PK and other biomarkers
Measured: 6 months
Amuvatinib PK interactions with platinum-etoposide chemotherapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completion28 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357395
- Sponsor's protocol ID
- SGI-0470-07
- Other IDs
- 2010-024378-21
- Acronym
- ESCAPE
- Status last verified
- Aug 2024
- First submitted
- 17 May 2011
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01357395
- Acronym / sponsor ID
- ESCAPE / SGI-0470-07
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Small Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- 28 May 2012 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amuvatinib | Experimental | Drug: AmuvatinibAmuvatinib 300 mg PO TID + standard-of-care platinum-etoposide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmuvatinibAlso: MP-470Amuvatinib 300 mg PO TID | Drug | Amuvatinib |
Primary outcome
Overall objective response rate (CR or PR)
Time frame: 3 months
6 secondary outcomes
Progression-free survival and overall survival
Time frame: 6 months
Disease control rate
Time frame: 6 months
Duration of response
Time frame: 6 months
Safety and tolerability
Time frame: 6 months
Amuvatinib and metabolites PK and other biomarkers
Time frame: 6 months
Amuvatinib PK interactions with platinum-etoposide chemotherapy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amuvatinib in people with Small Cell Lung Carcinoma, run by Astex Pharmaceuticals, Inc. at 12 sites in 2 countries.
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 11 inclusion and 7 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: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall objective response rate (CR or PR) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2024.