Small Cell Lung CancerPhase 2[SUKSES-D]NCT03106155
Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification
A Phase 2 study testing vistusertib (AZD2014) in people with Small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
[Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- vistusertib (AZD2014)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2017to 29 Jun 2018
- 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
None listed.
Who cannot join
- Participation in another clinical study with an investigational product during the last 21 days.
- Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
- Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
- Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
- Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
- Any haemopoietic growth factors within 14 days prior to receiving study treatment.
- Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
- Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Single-arm Study of Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification(SUKSE-D)
[Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.
[Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy
- Conditions
- Small Cell Lung Cancer
- Being tested
- vistusertib (AZD2014)
- 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.
vistusertib (AZD2014)Drug
vistusertib(AZD2014): 50 mg BID per os every 12 hours administration daily. One cycle is consisted of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| vistusertib (AZD2014) | Experimental | vistusertib (AZD2014), 50 mg,BID, per os, every 12 hours Receives: Drug: vistusertib (AZD2014) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective reponse rate (ORR) by RECIST 1.1
Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
Measured: Up to 20 months
Secondary outcomes (5)
Duration of response
Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
Measured: Up to 20 months
Disease control rate
Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
Measured: at 12 weeks
Overall survival (OS)
Kaplan-Meier method
Measured: Up to 20 months
Progression-free survival (PFS)
Kaplan-Meier method
Measured: Up to 20 months
Number of participants with Adverse Events as Assessed by CTCAE v4.03
CTCAE v4.03
Measured: Up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start2 Aug 2017
- Primary completion3 May 2018
- Study completion29 Jun 2018
Why it stopped: Decision of IP support organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- Vistusertib monotherapy (50 mg BID per os every 12 hours)
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Keunchil Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106155
- Sponsor's protocol ID
- 2017-01-003
- Acronym
- [SUKSES-D]
- Status last verified
- Sep 2018
- First submitted
- 4 Apr 2017
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single-arm Study of Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification(SUKSE-D)
- ClinicalTrials.gov ID
- NCT03106155
- Acronym / sponsor ID
- [SUKSES-D] / 2017-01-003
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision of IP support organization
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- 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.
[Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.
[Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Vistusertib monotherapy (50 mg BID per os every 12 hours)
| Arm | Type | Receives |
|---|---|---|
| vistusertib (AZD2014) | Experimental | Drug: vistusertib (AZD2014)vistusertib (AZD2014), 50 mg,BID, per os, every 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Participation in another clinical study with an investigational product during the last 21 days.
- Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
- Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
- Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
- Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
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 |
|---|---|---|
| vistusertib (AZD2014)vistusertib(AZD2014): 50 mg BID per os every 12 hours administration daily. One cycle is consisted of 3 weeks. | Drug | vistusertib (AZD2014) |
Primary outcome
Objective reponse rate (ORR) by RECIST 1.1
Time frame: Up to 20 months
Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
5 secondary outcomes
Duration of response
Time frame: Up to 20 months
Disease control rate
Time frame: at 12 weeks
Overall survival (OS)
Time frame: Up to 20 months
Progression-free survival (PFS)
Time frame: Up to 20 months
Number of participants with Adverse Events as Assessed by CTCAE v4.03
Time frame: Up to 20 months
Results and safety
The study was stopped early (reason given: Decision of IP support organization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vistusertib (AZD2014) in people with Small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 0 inclusion and 8 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 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 was stopped early (reason given: Decision of IP support organization). 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?
Objective reponse rate (ORR) by RECIST 1.1 (time frame: Up to 20 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 20 Sep 2018.