Recurrent Platinum-resistant Ovarian CancerPhase 1/2NCT01653912
Dose-finding Study in Platinum-Resistant Ovarian Cancer
A Phase 1/2 study testing GSK2110183 in combination with carboplatin and paclitaxel in people with Recurrent Platinum-resistant Ovarian Cancer, run by Accenture at 10 sites in 3 countries.
Trial summary
Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer. Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Platinum-resistant Ovarian Cancer
- What is being tested?
- GSK2110183 in combination with carboplatin and paclitaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Nov 2012to Nov 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of another malignancy (some exceptions may apply)
- Serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
- Current use of prohibited medication during treatment.
- Chemotherapy, immunotherapy, or other anti-cancer therapy within 14 days prior to the first dose study drug
- Radiotherapy prior to initiation of therapy (some exceptions may apply)
- Contraindications (identified by the investigator) to the doses of carboplatin and/or paclitaxel
Show all 23Show fewer
- History of reduction in standard of care paclitaxel dose for peripheral neuropathy
- No known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs similar or related to GSK2110183
- No known delayed hypersensitivity reaction or idiosyncratic reaction to drugs similar to carboplatin or paclitaxel (some exceptions may apply)
- Prior use of a drug that targets AKT including perifosine
- History of Type 1 diabetes
- Gastrointestinal disease or other condition that could affect absorption or predispose subject to gastrointestinal ulceration
- Mucosal or internal bleeding
- Major surgery within the last four weeks
- Infection requiring parenteral or oral anti-infective treatment
- Severe or uncontrolled systemic diseases
- Brain metastases and/or leptomeningeal disease
- QTcF interval ≥ 470 msecs
- Bundle branch block, pacemaker or clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty,stenting or bypass grafting within six months of Screening
- Class II, III or IV heart failure as defined by the NYHA functional classification system
- Pregnant or lactating female
- Malignancies related to HIV or solid organ transplant; history of known HIV, history of know HBV surface antigen positivity (subjects with documented laboratory evidence of HBV clearance may be enrolled) or positive HCV antibody
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Australia5 sites
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 8006
Western Hospital
Footscray, Victoria, 3011
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Women's Hospital
Parkville, Victoria, 3052
United Kingdom3 sites
Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surry, GU2 7XP
Imperial College Healthcare NHS Trust
London, W 12 0HS
Mount Vernon Cancer Center
Northwood, Middlesex, London, HA6 2RN
Russia2 sites
Medical Radiology Scientific Center of Ministry of Healthcare and Social Development of RF
Omskaya, 249036
City Clinical Oncology Dispensary
Saint Petersburg, 198255
About this study
Official title: An Open-Label Phase I/II Study of GSK2110183 in Combination With Carboplatin and Paclitaxel in Subjects With Platinum-Resistant Ovarian Cancer
- Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer.
- Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer.
Read the detailed description
PKB116611 is an open-label Phase I/II study of the investigational drug GSK2110183 given in combination with carboplatin and paclitaxel to subjects with recurrent ovarian cancer. Phase I is a dose escalation evaluation of daily oral doses of GSK2110183 administered in combination with every 3 week carboplatin and paclitaxel to any subject with recurrent ovarian cancer. Phase II is a single arm evaluation of the clinical efficacy of the combination identified in Phase I to subjects with platinum-resistant ovarian cancer.
- Being tested
- GSK2110183 in combination with carboplatin and paclitaxel
- Keywords
- cancer, ovarian, platinum-resistant
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2110183 in combination with carboplatin and paclitaxelDrug
Also called Taxol (paclitaxel), Paraplatin (carboplatin), AKT Inhibitor
Phase I is a dose escalation evaluation of increasing doses of GSK2110183 administered on a continuous daily schedule in combination with carboplatin AUC 5 and paclitaxel 175mg/m2 given every three weeks for a maximum 6 cycles. The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. Treatment with the three drug regimen will continue for a maximum of 6 x 21 day cycles followed by continuous GSK2110183 at the single agent MTD. Subjects may continue on study drug until progression, death or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| GSK2110183, carboplatin and paclitaxel | Experimental | Subjects will be treated with a maximum of six doses of carboplatin + paclitaxel in combination with continuous daily GSK2110183 followed by single agent GSK2110183 at the single-agent MTD of 125 mg or above oral daily. Receives: Drug: GSK2110183 in combination with carboplatin and paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade Greater Than or Equal to (≥) 3 in Severity
Measured: Up to Week 3
Phase 1 Safety: Number of Subjects Reporting Adverse Events
Study Treatment refers to GSK2110183 with or without Carboplatin and/or Paclitaxel.
Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug \& occurs within first 3 weeks of therapy \& met at least one of the following criteria:
- Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 [NCI, 2009] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).
- Grade 4 neutropenia lasting ≥5 days
- Febrile neutropenia
- Grade 3 thrombocytopenia with bleeding
- Grade 4 thrombocytopenia
- Grade 4 anemia
- Treatment delay of >14 days due to unresolved toxicity
- Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) with bilirubin >2 times ULN
Measured: Up to Week 3
Phase 1: Maximum Tolerated Dose (MTD) of GSK2110183
MTD is defined as the highest dose at which 1 or fewer of up to 6 subjects experience a dose limiting toxicity (DLT) during the first 3 weeks of combination therapy. MTD was considered exceeded if 2 or more subjects in a cohort of up to 6 subjects experienced a DLT.
Measured: Up to Week 3
Overall Response Rate (ORR) in Phase 2 Subjects With Recurrent Platinum-resistant Ovarian Cancer (Cohort A)
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is greater than or equal to (≥) 30% decrease in the sum of the longest diameter of target lesions.
Overall Response (OR) = CR + PR.
Measured: Every 3 weeks up to 6 months
ORR in Phase 2 Subjects With Recurrent Platinum-refractory Ovarian Cancer (Cohort B)
Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.
Overall Response (OR) = CR + PR.
Measured: Every 3 weeks up to 6 months
Secondary outcomes (6)
ORR in Phase 1 Subjects With Recurrent Platinum-resistant Ovarian Cancer
Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.
Overall Response (OR) = CR + PR.
Measured: Up to Week 3
Phase 2: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade ≥3 in Severity
Measured: Up to Day 21 (Phase 2)
Phase 2 Safety: Number of Subjects Reporting Adverse Events
Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug \& occurs within first 3 weeks of therapy \& met at least one of the following criteria:
- Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 [NCI, 2009] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).
- Grade 4 neutropenia lasting ≥5 days
- Febrile neutropenia
- Grade 3 thrombocytopenia with bleeding
- Grade 4 thrombocytopenia
- Grade 4 anemia
- Treatment delay of >14 days due to unresolved toxicity
- Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) with bilirubin >2 times ULN
Measured: Up to Day 51
Phase 2: Response Rate (RR) Defined by Gynecologic Cancer Intergroup (GCIG) CA 125
RR is defined by the percentage of subjects with investigator-assessed Partial Cancer Antigen (CA) 125 Response (PR) or Complete CA 125 Response (CR) at any time during the study by GCIG CA 125. PR is greater than (>) 50% decrease in CA-125 values from baseline and no clinical or radiological evidence of new lesions. CR is decrease in the CA-125 to within the normal limits and less than (<) 40 IU/mL and no clinical or radiological evidence of disease.
Measured: From Month 1 to 6
Progression Free Survival (PFS) by RECIST or Clinical Symptomatic Progression of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)
PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or clinical symptomatic progression or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.
Measured: From first dose until disease progression or death (approximately 36 months)
PFS by RECIST of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)
PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.
Measured: From first dose until disease progression or death (approximately 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Platinum-resistant Ovarian CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accenture
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard A Brigandi, MD, PhD, FAAP, Study director, GlaxoSmithKlineAnne L Hamilton, Principal investigator, Royal Women's HospitalSarah P Blagden, Principal investigator, Imperial College Healthcare NHS TrustLinda Mileshkin, Principal investigator, Peter MacCallum Cancer Centre, AustraliaShirley S Wong, Principal investigator, Western HospitalAndrew Dean, Principal investigator, Sir Charles Gairdner HospitalMarcia Hall, Principal investigator, Mount Vernon Cancer CenterBhawana Awasthy, MD, Study director, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653912
- Sponsor's protocol ID
- PKB116611
- Other IDs
- 2012-002483-27
- Status last verified
- Aug 2017
- First submitted
- 27 Jul 2012
- Last updated
- 2 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Blagden SP, Hamilton AL, Mileshkin L, Wong S, Michael A, Hall M, Goh JC, Lisyanskaya AS, DeSilvio M, Frangou E, Stronach EA, Gopalakrishna P, Meniawy TM, Gabra H. Phase IB Dose Escalation and Expansion Study of AKT Inhibitor Afuresertib with Carboplatin and Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer. Clin Cancer Res. 2019 Mar 1;25(5):1472-1478. doi: 10.1158/1078-0432.CCR-18-2277. Epub 2018 Dec 18.
PubMed 30563934
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase I/II Study of GSK2110183 in Combination With Carboplatin and Paclitaxel in Subjects With Platinum-Resistant Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01653912
- Acronym / sponsor ID
- PKB116611
- Keywords
- cancer, ovarian, platinum-resistant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AccentureIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 2 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer.
- Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer.
Detailed description
PKB116611 is an open-label Phase I/II study of the investigational drug GSK2110183 given in combination with carboplatin and paclitaxel to subjects with recurrent ovarian cancer. Phase I is a dose escalation evaluation of daily oral doses of GSK2110183 administered in combination with every 3 week carboplatin and paclitaxel to any subject with recurrent ovarian cancer. Phase II is a single arm evaluation of the clinical efficacy of the combination identified in Phase I to subjects with platinum-resistant ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK2110183, carboplatin and paclitaxel | Experimental | Drug: GSK2110183 in combination with carboplatin and paclitaxelSubjects will be treated with a maximum of six doses of carboplatin + paclitaxel in combination with continuous daily GSK2110183 followed by single agent GSK2110183 at the single-agent MTD of 125 mg or above oral daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (23 listed)
- History of another malignancy (some exceptions may apply)
- Serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
- Current use of prohibited medication during treatment.
- Chemotherapy, immunotherapy, or other anti-cancer therapy within 14 days prior to the first dose study drug
- Radiotherapy prior to initiation of therapy (some exceptions may apply)
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 |
|---|---|---|
| GSK2110183 in combination with carboplatin and paclitaxelAlso: Taxol (paclitaxel), Paraplatin (carboplatin), AKT InhibitorPhase I is a dose escalation evaluation of increasing doses of GSK2110183 administered on a continuous daily schedule in combination with carboplatin AUC 5 and paclitaxel 175mg/m2 given every three weeks for a maximum 6 cycles. The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. Treatment with the three drug regimen will continue for a maximum of 6 x 21 day cycles followed by continuous GSK2110183 at the single agent MTD. Subjects may continue on study drug until progression, death or unacceptable toxicity. | Drug | GSK2110183, carboplatin and paclitaxel |
Primary outcome
Phase 1: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade Greater Than or Equal to (≥) 3 in Severity
Time frame: Up to Week 3
Phase 1 Safety: Number of Subjects Reporting Adverse Events
Time frame: Up to Week 3
Study Treatment refers to GSK2110183 with or without Carboplatin and/or Paclitaxel. Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug \& occurs within first 3 weeks of therapy \& met at least one of the following criteria: * Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 [NCI, 2009] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours). * Grade 4 neutropenia lasting ≥5 days * Febrile neutropenia * Grade 3 thrombocytopenia with bleeding * Grade 4 thrombocytopenia * Grade 4 anemia * Treatment delay of >14 days due to unresolved toxicity * Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) with bilirubin >2 times ULN
Phase 1: Maximum Tolerated Dose (MTD) of GSK2110183
Time frame: Up to Week 3
MTD is defined as the highest dose at which 1 or fewer of up to 6 subjects experience a dose limiting toxicity (DLT) during the first 3 weeks of combination therapy. MTD was considered exceeded if 2 or more subjects in a cohort of up to 6 subjects experienced a DLT.
Overall Response Rate (ORR) in Phase 2 Subjects With Recurrent Platinum-resistant Ovarian Cancer (Cohort A)
Time frame: Every 3 weeks up to 6 months
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is greater than or equal to (≥) 30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.
ORR in Phase 2 Subjects With Recurrent Platinum-refractory Ovarian Cancer (Cohort B)
Time frame: Every 3 weeks up to 6 months
Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.
6 secondary outcomes
ORR in Phase 1 Subjects With Recurrent Platinum-resistant Ovarian Cancer
Time frame: Up to Week 3
Phase 2: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade ≥3 in Severity
Time frame: Up to Day 21 (Phase 2)
Phase 2 Safety: Number of Subjects Reporting Adverse Events
Time frame: Up to Day 51
Phase 2: Response Rate (RR) Defined by Gynecologic Cancer Intergroup (GCIG) CA 125
Time frame: From Month 1 to 6
Progression Free Survival (PFS) by RECIST or Clinical Symptomatic Progression of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)
Time frame: From first dose until disease progression or death (approximately 36 months)
PFS by RECIST of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)
Time frame: From first dose until disease progression or death (approximately 36 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30563934Blagden SP, Hamilton AL, Mileshkin L, Wong S, Michael A, Hall M, Goh JC, Lisyanskaya AS, DeSilvio M, Frangou E, Stronach EA, Gopalakrishna P, Meniawy TM, Gabra H. Phase IB Dose Escalation and Expansion Study of AKT Inhibitor Afuresertib with Carboplatin and Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer. Clin Cancer Res. 2019 Mar 1;25(5):1472-1478. doi: 10.1158/1078-0432.CCR-18-2277. Epub 2018 Dec 18.
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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.
Richard A Brigandi, MD, PhD, FAAP study director
GlaxoSmithKline
Anne L Hamilton principal investigator
Royal Women's Hospital
Sarah P Blagden principal investigator
Imperial College Healthcare NHS Trust
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GSK2110183 in combination with carboplatin and paclitaxel in people with Recurrent Platinum-resistant Ovarian Cancer, run by Accenture at 10 sites in 3 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 0 inclusion and 23 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, United Kingdom, Russia. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 2 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase 1: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade Greater Than or Equal to (≥) 3 in Severity (time frame: Up to Week 3). The study lists 5 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 NCT01653912, 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 2 Apr 2018.