Mesothelioma, MalignantPhase 2NCT02303899
Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Pleural Mesothelioma
A Phase 2 study testing Gemcitabine and Imatinib mesylate in people with Mesothelioma, Malignant, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This is a phase II, monocentric study of the combination of gemcitabine and imatinib mesylate in pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by Immunohistochemistry (IHC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Malignant
- What is being tested?
- Gemcitabine and Imatinib mesylate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2014to Dec 2017
- 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
- Age of > 18 years.
- Histologically proven malignant mesothelioma of the pleura or of the peritoneum, expressing PDGFR-beta and/or C-kit by immunohistochemistry.
- Locally advanced disease, unsuitable for curative surgical resection, or metastatic disease.
- Confirmed progression of the disease according to modified RECIST-criteria, documented after a pemetrexed-based chemotherapy.
- Eastern Cooperative Oncology group (ECOG) Performance Status of 0, 1 or 2.
- Life expectancy of at least 3 months.
- Written informed consent.
Who cannot join
- Co-existing tumors of different histologic origin, except non melanomatous localized skin cancer and/or in situ cervical carcinoma.
- A history of earlier tumors of different histologic origin being in complete remission for less than 5 years.
- Unresolved toxicity from prior antitumor treatment(s).
- Primary peritoneal mesothelioma.
- Any of the following abnormal baseline hematological values:
- Hb < 9 g/dL
Show all 18Show fewer
- White blood count (WBC) < 3 x 109/L
- Neutrophils < 1.5 x 109/L
- Platelets < 100 x 109/L
- Serum bilirubin > 2.5 mg/dL
- Alanine transaminase (ALAT) and Aspartate transaminase (ASAT) > 3 x upper normal limit (UNL) (unless due to liver metastases)
- Serum creatinine > 1.5 mg/dL.
- Symptomatic and/or unstable pre-existing brain metastases. To be enrolled in the study, subjects must have confirmation of stable disease by MRI or computer tomography (CT) scan within 4 weeks from day 1 of cycle 1 of treatment and have central nervous system (CNS) metastases well controlled by steroids, anti - epileptics or other symptom-relieving medications.
- Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in New York Heart Association (NYHA) class II or more.
- History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent.
- Pregnant or lactating women or inability/unwillingness to practice a medically approved method of contraception during study period (including 3 months following the end of treatment)
- Uncontrolled active infections.
- Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of the Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Malignant Pleural Mesothelioma
This is a phase II, monocentric study of the combination of gemcitabine and imatinib mesylate in pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by Immunohistochemistry (IHC). Treatment will be done until disease progression, or patient refusal or withdrawal of patient consent, or unacceptable toxicity
Read the detailed description
Pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by IHC will receive chemotherapy as follow :
- Gemcitabine 1000 mg/m2, i.v., days 3 and 10 of a 21-days schedule;
- Imatinib mesylate 400 mg/die orally on days 1-5 and 8-12 of a 21-days schedule.
Treatment repeats every 21 days in the absence of disease progression, patient refusal or withdrawal of patient consent, or unacceptable toxicity.
The molecular profile of patients enrolled will be evaluated with Ion Personal Genome Machine (PGM) Torrent Next-generation Sequencing platform in order to individuate potential predictive biomarkers and to improve the understanding of the molecular biology of these rare tumors. A correlation among the molecular profiles identified, clinical characteristics, and survival data of patients will be done
- Conditions
- Mesothelioma, Malignant
- Being tested
- Gemcitabine, Imatinib mesylate
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
infusion drug
Imatinib mesylateDrug
Also called Glivec
oral drug
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine & Imatinib mesylate | Experimental | Gemcitabine 1000 mg/m2, i.v., days 3 and 10 of a 21-days schedule; Imatinib mesylate 400 mg/die orally on days 1-5 and 8-12 of a 21-days schedule. Receives: Drug: Gemcitabine; Drug: Imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine
assess the anti-tumor activity of Imatinib mesylate in combination with Gemcitabine, in terms of 3-months progression-free survival (PFS) rate
Measured: 12 weeks
Secondary outcomes (4)
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine in terms of Response Evaluation Criteria In Solid Tumors (RECIST) criteria
assess anti-tumor activity of Imatinib Mesylate (IM) in combination with GEM, in terms of objective response rate according to RECIST criteria (Modified RECIST criteria for MPM), and duration of response
Measured: 16 weeks
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine in terms of overall survival (OS).
assess anti-tumor activity of IM in combination with GEM, in terms of overall survival (OS).
Measured: 30 months
safety profile of the combination according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3
determine the safety profile of the combination according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3
Measured: 16 weeks
molecular profile of patients
evaluate the molecular profile of patients enrolled with Ion PGM Torrent Next-generation Sequencing platform correlating the molecular profiles identified with clinical characteristics and survival data of patients.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Mesothelioma, MalignantStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303899
- Sponsor's protocol ID
- ONC-2014-002
- Status last verified
- Jan 2021
- First submitted
- 19 Nov 2014
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: not planned
Publications
Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136.
PubMed 12860938Ceresoli GL, Zucali PA, Favaretto AG, Grossi F, Bidoli P, Del Conte G, Ceribelli A, Bearz A, Morenghi E, Cavina R, Marangolo M, Parra HJ, Santoro A. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol. 2006 Mar 20;24(9):1443-8. doi: 10.1200/JCO.2005.04.3190.
PubMed 16549838Castagneto B, Botta M, Aitini E, Spigno F, Degiovanni D, Alabiso O, Serra M, Muzio A, Carbone R, Buosi R, Galbusera V, Piccolini E, Giaretto L, Rebella L, Mencoboni M. Phase II study of pemetrexed in combination with carboplatin in patients with malignant pleural mesothelioma (MPM). Ann Oncol. 2008 Feb;19(2):370-3. doi: 10.1093/annonc/mdm501. Epub 2007 Dec 20.
PubMed 18156144Santoro A, O'Brien ME, Stahel RA, Nackaerts K, Baas P, Karthaus M, Eberhardt W, Paz-Ares L, Sundstrom S, Liu Y, Ripoche V, Blatter J, Visseren-Grul CM, Manegold C. Pemetrexed plus cisplatin or pemetrexed plus carboplatin for chemonaive patients with malignant pleural mesothelioma: results of the International Expanded Access Program. J Thorac Oncol. 2008 Jul;3(7):756-63. doi: 10.1097/JTO.0b013e31817c73d6.
PubMed 18594322Ceresoli GL, Zucali PA, Gianoncelli L, Lorenzi E, Santoro A. Second-line treatment for malignant pleural mesothelioma. Cancer Treat Rev. 2010 Feb;36(1):24-32. doi: 10.1016/j.ctrv.2009.09.003. Epub 2009 Oct 29.
PubMed 19879055Pietras K, Ostman A, Sjoquist M, Buchdunger E, Reed RK, Heldin CH, Rubin K. Inhibition of platelet-derived growth factor receptors reduces interstitial hypertension and increases transcapillary transport in tumors. Cancer Res. 2001 Apr 1;61(7):2929-34.
PubMed 11306470Pietras K, Rubin K, Sjoblom T, Buchdunger E, Sjoquist M, Heldin CH, Ostman A. Inhibition of PDGF receptor signaling in tumor stroma enhances antitumor effect of chemotherapy. Cancer Res. 2002 Oct 1;62(19):5476-84.
PubMed 12359756Pietras K, Stumm M, Hubert M, Buchdunger E, Rubin K, Heldin CH, McSheehy P, Wartmann M, Ostman A. STI571 enhances the therapeutic index of epothilone B by a tumor-selective increase of drug uptake. Clin Cancer Res. 2003 Sep 1;9(10 Pt 1):3779-87.
PubMed 14506171Garlepp MJ, Leong CC. Biological and immunological aspects of malignant mesothelioma. Eur Respir J. 1995 Apr;8(4):643-50.
PubMed 7664867Langerak AW, van der Linden-van Beurden CA, Versnel MA. Regulation of differential expression of platelet-derived growth factor alpha- and beta-receptor mRNA in normal and malignant human mesothelial cell lines. Biochim Biophys Acta. 1996 Feb 7;1305(1-2):63-70. doi: 10.1016/0167-4781(95)00196-4.
PubMed 8605252Pogrebniak HW, Lubensky IA, Pass HI. Differential expression of platelet derived growth factor-beta in malignant mesothelioma: a clue to future therapies? Surg Oncol. 1993 Aug;2(4):235-40. doi: 10.1016/0960-7404(93)90012-n.
PubMed 8252214Klominek J, Baskin B, Hauzenberger D. Platelet-derived growth factor (PDGF) BB acts as a chemoattractant for human malignant mesothelioma cells via PDGF receptor beta-integrin alpha3beta1 interaction. Clin Exp Metastasis. 1998 Aug;16(6):529-39. doi: 10.1023/a:1006542301794.
PubMed 9872600Sawyers C. Targeted cancer therapy. Nature. 2004 Nov 18;432(7015):294-7. doi: 10.1038/nature03095.
PubMed 15549090Shih AH, Holland EC. Platelet-derived growth factor (PDGF) and glial tumorigenesis. Cancer Lett. 2006 Feb 8;232(2):139-47. doi: 10.1016/j.canlet.2005.02.002. Epub 2005 Aug 31.
PubMed 16139423Yu J, Ustach C, Kim HR. Platelet-derived growth factor signaling and human cancer. J Biochem Mol Biol. 2003 Jan 31;36(1):49-59. doi: 10.5483/bmbrep.2003.36.1.049.
PubMed 12542975
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Combination of Gemcitabine and Imatinib Mesylate in Pemetrexed-pretreated Patients With Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT02303899
- Acronym / sponsor ID
- ONC-2014-002
- Conditions
- Mesothelioma, Malignant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Dec 2014 (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.
This is a phase II, monocentric study of the combination of gemcitabine and imatinib mesylate in pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by Immunohistochemistry (IHC). Treatment will be done until disease progression, or patient refusal or withdrawal of patient consent, or unacceptable toxicity
Detailed description
Pemetrexed-pretreated patients with MPM expressing PDGFR-beta and/or C-kit by IHC will receive chemotherapy as follow :
- Gemcitabine 1000 mg/m2, i.v., days 3 and 10 of a 21-days schedule;
- Imatinib mesylate 400 mg/die orally on days 1-5 and 8-12 of a 21-days schedule.
Treatment repeats every 21 days in the absence of disease progression, patient refusal or withdrawal of patient consent, or unacceptable toxicity.
The molecular profile of patients enrolled will be evaluated with Ion Personal Genome Machine (PGM) Torrent Next-generation Sequencing platform in order to individuate potential predictive biomarkers and to improve the understanding of the molecular biology of these rare tumors. A correlation among the molecular profiles identified, clinical characteristics, and survival data of patients will be done
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine & Imatinib mesylate | Experimental | Drug: Gemcitabine, Drug: Imatinib mesylateGemcitabine 1000 mg/m2, i.v., days 3 and 10 of a 21-days schedule; Imatinib mesylate 400 mg/die orally on days 1-5 and 8-12 of a 21-days schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of > 18 years.
- Histologically proven malignant mesothelioma of the pleura or of the peritoneum, expressing PDGFR-beta and/or C-kit by immunohistochemistry.
- Locally advanced disease, unsuitable for curative surgical resection, or metastatic disease.
- Confirmed progression of the disease according to modified RECIST-criteria, documented after a pemetrexed-based chemotherapy.
- Eastern Cooperative Oncology group (ECOG) Performance Status of 0, 1 or 2.
Key exclusion criteria (18 listed)
- Co-existing tumors of different histologic origin, except non melanomatous localized skin cancer and/or in situ cervical carcinoma.
- A history of earlier tumors of different histologic origin being in complete remission for less than 5 years.
- Unresolved toxicity from prior antitumor treatment(s).
- Primary peritoneal mesothelioma.
- Any of the following abnormal baseline hematological values:
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 |
|---|---|---|
| GemcitabineAlso: Gemzarinfusion drug | Drug | Gemcitabine & Imatinib mesylate |
| Imatinib mesylateAlso: Glivecoral drug | Drug | Gemcitabine & Imatinib mesylate |
Primary outcome
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine
Time frame: 12 weeks
assess the anti-tumor activity of Imatinib mesylate in combination with Gemcitabine, in terms of 3-months progression-free survival (PFS) rate
4 secondary outcomes
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine in terms of Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Time frame: 16 weeks
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine in terms of overall survival (OS).
Time frame: 30 months
safety profile of the combination according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3
Time frame: 16 weeks
molecular profile of patients
Time frame: baseline
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 22 Jan 2021.
- Background: PubMed 12860938Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136.
- Background: PubMed 16549838Ceresoli GL, Zucali PA, Favaretto AG, Grossi F, Bidoli P, Del Conte G, Ceribelli A, Bearz A, Morenghi E, Cavina R, Marangolo M, Parra HJ, Santoro A. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol. 2006 Mar 20;24(9):1443-8. doi: 10.1200/JCO.2005.04.3190.
- Background: PubMed 18156144Castagneto B, Botta M, Aitini E, Spigno F, Degiovanni D, Alabiso O, Serra M, Muzio A, Carbone R, Buosi R, Galbusera V, Piccolini E, Giaretto L, Rebella L, Mencoboni M. Phase II study of pemetrexed in combination with carboplatin in patients with malignant pleural mesothelioma (MPM). Ann Oncol. 2008 Feb;19(2):370-3. doi: 10.1093/annonc/mdm501. Epub 2007 Dec 20.
- Background: PubMed 18594322Santoro A, O'Brien ME, Stahel RA, Nackaerts K, Baas P, Karthaus M, Eberhardt W, Paz-Ares L, Sundstrom S, Liu Y, Ripoche V, Blatter J, Visseren-Grul CM, Manegold C. Pemetrexed plus cisplatin or pemetrexed plus carboplatin for chemonaive patients with malignant pleural mesothelioma: results of the International Expanded Access Program. J Thorac Oncol. 2008 Jul;3(7):756-63. doi: 10.1097/JTO.0b013e31817c73d6.
- Background: PubMed 19879055Ceresoli GL, Zucali PA, Gianoncelli L, Lorenzi E, Santoro A. Second-line treatment for malignant pleural mesothelioma. Cancer Treat Rev. 2010 Feb;36(1):24-32. doi: 10.1016/j.ctrv.2009.09.003. Epub 2009 Oct 29.
- Background: PubMed 11306470Pietras K, Ostman A, Sjoquist M, Buchdunger E, Reed RK, Heldin CH, Rubin K. Inhibition of platelet-derived growth factor receptors reduces interstitial hypertension and increases transcapillary transport in tumors. Cancer Res. 2001 Apr 1;61(7):2929-34.
- Background: PubMed 12359756Pietras K, Rubin K, Sjoblom T, Buchdunger E, Sjoquist M, Heldin CH, Ostman A. Inhibition of PDGF receptor signaling in tumor stroma enhances antitumor effect of chemotherapy. Cancer Res. 2002 Oct 1;62(19):5476-84.
- Background: PubMed 14506171Pietras K, Stumm M, Hubert M, Buchdunger E, Rubin K, Heldin CH, McSheehy P, Wartmann M, Ostman A. STI571 enhances the therapeutic index of epothilone B by a tumor-selective increase of drug uptake. Clin Cancer Res. 2003 Sep 1;9(10 Pt 1):3779-87.
- Background: PubMed 7664867Garlepp MJ, Leong CC. Biological and immunological aspects of malignant mesothelioma. Eur Respir J. 1995 Apr;8(4):643-50.
- Background: PubMed 8605252Langerak AW, van der Linden-van Beurden CA, Versnel MA. Regulation of differential expression of platelet-derived growth factor alpha- and beta-receptor mRNA in normal and malignant human mesothelial cell lines. Biochim Biophys Acta. 1996 Feb 7;1305(1-2):63-70. doi: 10.1016/0167-4781(95)00196-4.
- Background: PubMed 8252214Pogrebniak HW, Lubensky IA, Pass HI. Differential expression of platelet derived growth factor-beta in malignant mesothelioma: a clue to future therapies? Surg Oncol. 1993 Aug;2(4):235-40. doi: 10.1016/0960-7404(93)90012-n.
- Background: PubMed 9872600Klominek J, Baskin B, Hauzenberger D. Platelet-derived growth factor (PDGF) BB acts as a chemoattractant for human malignant mesothelioma cells via PDGF receptor beta-integrin alpha3beta1 interaction. Clin Exp Metastasis. 1998 Aug;16(6):529-39. doi: 10.1023/a:1006542301794.
- 27\) National Cancer Institute. Common toxicity criteria manual, version 3.0, July 16, 2003.Link provided by the sponsor.
- Individual participant dataSharing planned: No. not planned
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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.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
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 Gemcitabine and Imatinib mesylate in people with Mesothelioma, Malignant, run by Istituto Clinico Humanitas at 1 site in Italy.
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 7 inclusion and 18 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 22 Jan 2021. 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 Italy. 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?
anti-tumor activity of Imatinib mesylate in combination with Gemcitabine (time frame: 12 weeks). 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 NCT02303899, which also lists 26 linked publications.
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 22 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.