Cancer of StomachPhase 2NCT03082833
Phase II Trial of AZD2014 in TSC1/2 Mutated or TSC1/2 Null GC Patients as Second-line Chemotherapy
A Phase 2 study testing AZD2014 in people with Cancer of Stomach, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Phase II trial of AZD2014 in TSC1/2 mutated or TSC1/2 null GC patients as second-line chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Stomach
- What is being tested?
- AZD2014
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2017to 16 Nov 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
- Provision of fully informed consent prior to any study specific procedures.
- Patients must be ≥20 years of age.
- Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after first-line therapy.
- The 1st line regimen must have contained doublet 5-fluoropyrimidine and platinum based regimen.
- Relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing doublet 5-fluoropyrimidine and platinum-based regimen could be considered as 1st line therapy.
- Acceptable prior chemotherapy regimens for this protocol are chemotherapy regimens that include Immune Target agent therapy. (such as a pembrolizumab, ramucirumab etc)
Show all 22Show fewer
- Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the 1st line therapy.
- Provision of tumor sample (from eith tumor sample (from eith tumor sample (from eith tumor sample (from eith tumor sample (from eith er a resection or biopsy)er a resection or biopsy) er a resection or biopsy)er a resection or biopsy) er a resection or biopsy)er a resection or biopsy)er a resection or biopsy)er a resection or biopsy)er a resection or biopsy) er a resection or biopsy) er a resection or biopsy) er a resection or biopsy)er a resection or biopsy)
- Patients with TSC1/2 mutation or null through the VIKTORY trial. (The VIKTORY trial uses Ion Torrent PGM to screen for a panel of cancer mutations and nanostring copy number variation panel (see addendum for the VIKTORY trial). Types of TSC1/2 mutation for this trial was defined in VIKTORY lab manual
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- ECOG performance status 0-2.
- Patients must have a life expectancy ≥ 3 months from proposed first dose date.
- Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
- Haemoglobin ≥9.0 g/dL (transfusion allowed)
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- White blood cells (WBC) > 3 x 109/L
- Platelet count ≥100 x 109/L (transfusion allowed)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
- Serum creatinine ≤1.5 x institutional ULN
- At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
- Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.Or Patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: Post-menopausal - defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation
Who cannot join
- 1. More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting.
- 2. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
- 3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
- 4. Patients unable to swallow orally administered medication. 5. Previous major surgery within 4 weeks prior to enrollment. 6. For AZD2014: Exposure to potent or moderate inhibitors or inducers of CYP3A4/5 if taken within the stated washout periods before the first dose of study treatment 8. With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.
- 9. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
- 10. Resting ECG with measurable QTcB > 450 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- 11. Patients with cardiac problem as follows: uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy) Left ventricular ejection fraction <55% measured by echocardiography, Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest , Symptomatic heart failure (NYHA grade II-IV), Prior or current cardiomyopathy, Severe valvular heart disease, Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy), Acute coronary syndrome within 6 months prior to starting treatment 12. Active or untreated brain metastases or spinal cord compression Patients with treated brain metastases or spinal cord compression are eligible if they have minimal neurologic symptoms, evidence of stable disease (for at least 1 month) or response on follow-up scan, and require no corticosteroid therapy for ≥ 1 week.
- 13. Female patients who are breast-feeding or child-bearing 14. Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV) 15. Patients with proteinuria (3+ on dipstick analysis )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Samsung Medical Center
Phase II trial of AZD2014 in TSC1/2 mutated or TSC1/2 null GC patients as second-line chemotherapy
Read the detailed description
AZD2014 50mg BD continuous schedule of a 28 day cycle AZD2014 will be administered with orange juice in STG/TG patients. AZD2014 can be taken with or without food. The first dose of the day should be taken at approximately the same time each morning.The second dose of the day should be taken approximately 12 hours after the morning dose.
- Conditions
- Cancer of Stomach
- Being tested
- AZD2014
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2014Drug
AZD2014 is a selective dual mTOR kinase inhibitor targeting both mTORC1 (rapamycin sensitive) and mTORC2 (rapamycin insensitive) complexes of mammalian Target Of Rapamycin (mTOR).
| Study group | Role | What they receive |
|---|---|---|
| AZD2014 50mg BD | Experimental | AZD2014 50mg BD continuous schedule of a 28 day cycle Receives: Drug: AZD2014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) by RECIST 1.1
Objective response rate (ORR) by RECIST 1.1
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 posted17 Mar 2017
- Study start1 Feb 2017
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Why it stopped: lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of StomachStudies 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
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082833
- Sponsor's protocol ID
- 2016-08-016
- Status last verified
- May 2019
- First submitted
- 16 Feb 2017
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Samsung Medical Center
- ClinicalTrials.gov ID
- NCT03082833
- Acronym / sponsor ID
- 2016-08-016
- Conditions
- Cancer of Stomach
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of efficacy
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 17 Mar 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.
Phase II trial of AZD2014 in TSC1/2 mutated or TSC1/2 null GC patients as second-line chemotherapy
Detailed description
AZD2014 50mg BD continuous schedule of a 28 day cycle AZD2014 will be administered with orange juice in STG/TG patients. AZD2014 can be taken with or without food. The first dose of the day should be taken at approximately the same time each morning.The second dose of the day should be taken approximately 12 hours after the morning dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD2014 50mg BD | Experimental | Drug: AZD2014AZD2014 50mg BD continuous schedule of a 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Provision of fully informed consent prior to any study specific procedures.
- Patients must be ≥20 years of age.
- Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after first-line therapy.
- Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the 1st line therapy.
- Provision of tumor sample (from eith tumor sample (from eith tumor sample (from eith tumor sample (from eith tumor sample (from eith er a resection or biopsy)er a resection or biopsy) er a resection or biopsy)er a resection or biopsy) er a resection or biopsy)er a resection or biopsy)er a resection or biopsy)er a resection or biopsy)er a resection or biopsy) er a resection or biopsy) er a resection or biopsy) er a resection or biopsy)er a resection or biopsy)
Key exclusion criteria (8 listed)
- 1. More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting.
- 2. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
- 3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
- 4. Patients unable to swallow orally administered medication. 5. Previous major surgery within 4 weeks prior to enrollment. 6. For AZD2014: Exposure to potent or moderate inhibitors or inducers of CYP3A4/5 if taken within the stated washout periods before the first dose of study treatment 8. With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.
- 9. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
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 |
|---|---|---|
| AZD2014AZD2014 is a selective dual mTOR kinase inhibitor targeting both mTORC1 (rapamycin sensitive) and mTORC2 (rapamycin insensitive) complexes of mammalian Target Of Rapamycin (mTOR). | Drug | AZD2014 50mg BD |
Primary outcome
Objective response rate (ORR) by RECIST 1.1
Time frame: 6 months
Objective response rate (ORR) by RECIST 1.1
Results and safety
The study was stopped early (reason given: lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
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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 AZD2014 in people with Cancer of Stomach, 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 22 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 May 2019. 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: lack of efficacy). 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 response rate (ORR) by RECIST 1.1 (time frame: 6 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 May 2019.