CancerPhase 1NCT02404480
PTC596 in Patients With Advanced Solid Tumors
A Phase 1 study testing PTC596 in people with Cancer, run by PTC Therapeutics at 4 sites in 2 countries.
Trial summary
This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PTC596
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2016to 6 Feb 2017
- Phase
- Phase 1
- 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
- Patients must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, for which standard curative measures do not exist, that has progressed on at least one line of standard therapy or for which no standard therapies exists
- Discontinuation of all other therapies (including other investigational drugs, radiotherapy, or chemotherapy) for the treatment of cancer ≥4 weeks (≥6 weeks if nitrosoureas, ≥12 weeks if radiotherapy) before initiation of study treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- A measured or estimated creatinine clearance (CrCl) ≥60 mL/min/1.73 m2
Who cannot join
- Prior bone marrow/hematopoietic stem cell transplantation
- History of solid organ, bone marrow, or progenitor cell transplantation
- History of major surgical procedure within 28 days prior to start of study treatment
- Evidence of ongoing systemic bacterial, fungal, or viral infection. Known human immunodeficiency virus (HIV) infection or acquired-immunodeficiency syndrome (AIDS)-related illness
- Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Duke University
Durham, North Carolina, 27708
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: A Phase 1 Study of PTC596 in Patients With Advanced Solid Tumors
This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in patients with advanced cancer.
Read the detailed description
This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic (PK) study of PTC596 in patients with advanced cancer. A variation of the traditional 3+3 dose escalation design will be employed.
PTC596 will be administered orally on a twice a week (biw) schedule. Each 4-week period of drug administration will be considered one cycle. The objective of the study will be to determine the recommended Phase 2 dose (RP2D) and to determine preliminary proof of mechanism of action.
Collectively, data from the Good Laboratory Practice (GLP) and non-GLP studies indicate that 40 mg/kg biw is approximately the severely toxic dose in 10% of animals (STD 10). Therefore, the starting dose in this study will be calculated as one-tenth of the human equivalent dose (HED) of 40 mg/kg biw in rats, which is 0.65 mg/kg biw.
In this study, escalating dose levels will be evaluated to determine the RP2D. Three patients will be enrolled at the starting dose level (0.65 mg/kg biw); if 1 of the 3 patients experiences a dose-limiting toxicity (DLT), an additional 3 patients will be enrolled at the same dose level. Thus, 3 to 6 patients will receive the starting dose level of 0.65 mg/kg. Dose escalation will continue until the occurrence of DLT in ≥2/6 patients at a given dose level. Dose escalation will occur in approximately 100% increments until Grade ≥2, first-cycle toxicity is seen in at least 2 patients across all dose levels, after which dose escalation will occur in smaller (50% or 33%) increments.
- Conditions
- Cancer
- Being tested
- PTC596
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTC596Drug
PTC 596 will be administered orally twice a day until unmanageable toxicity, disease progression, or withdrawal of consent is noted
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | PTC 596 administered twice daily- Dose level 0.65mg/kg Receives: Drug: PTC596 |
| Cohort 2 | Experimental | PTC 596 administered twice daily-Dose level 1.3mg/kg Receives: Drug: PTC596 |
| Cohort 3 | Experimental | PTC 596 administered twice daily-2.6mg/kg Receives: Drug: PTC596 |
| Cohort 4 | Experimental | PTC 596 administered twice daily-Dose level 5.2mg/kg Receives: Drug: PTC596 |
| Cohort 5 | Experimental | PTC 596 administered twice daily-Dose level 10mg/kg Receives: Drug: PTC596 |
| Cohort 6 | Experimental | PTC 596 administered twice daily-Dose level 7mg/kg Receives: Drug: PTC596 |
| Cohort 7 (Bio Marker cohort) | Experimental | PTC 596 administered twice daily-Dose level 5.2mg/kg Receives: Drug: PTC596 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities
Determine the RP2D based on occurrence of DLTs and/or biological efficacy as determined by biomarker changes.
Measured: 28 days
Secondary outcomes (7)
Adverse effects
Define and describe the adverse effects of PTC596 in humans when orally administered on a biw schedule.
Measured: 28days
Time to Maximum Plasma Concentration (T max)
Evaluate the Time to Maximum Plasma Concentration (T max) of PTC596 in humans.
Measured: 28days
Antitumor activity
Describe any preliminary evidence of antitumor activity of PTC596.
Measured: 28days
Maximum Plasma Concentration (C max)
Evaluate the Maximum Plasma Concentration (C max) of PTC596 in humans
Measured: 28 days
Plasma Concentration at 24 hours
Evaluate the Plasma Concentration at 24 hours of PTC596 in humans
Measured: 28days
Area under the plasma concentration-time curve (AUC)
Evaluate the area under the plasma concentration-time curve (AUC) of PTC 596 in humans.
Measured: 28 days
Terminal half-life (t1/2).
Evaluate the terminal half-life (t1/2) of PTC 596 in humans.
Measured: 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJan 2016
- Primary completion6 Feb 2017
- Study completion6 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, first-in-human, safety and pharmacokinetic (PK)
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- PTC Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward O'Mara, MD, Study director, PTC Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404480
- Sponsor's protocol ID
- PTC596-ONC-001-AST
- Status last verified
- Dec 2017
- First submitted
- 24 Mar 2015
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdouh M, Facchino S, Chatoo W, Balasingam V, Ferreira J, Bernier G. BMI1 sustains human glioblastoma multiforme stem cell renewal. J Neurosci. 2009 Jul 15;29(28):8884-96. doi: 10.1523/JNEUROSCI.0968-09.2009.
PubMed 19605626American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. doi: 10.1200/JCO.2006.06.9591. Epub 2006 May 22.
PubMed 16717289Beck B, Blanpain C. Unravelling cancer stem cell potential. Nat Rev Cancer. 2013 Oct;13(10):727-38. doi: 10.1038/nrc3597.
PubMed 24060864Cao R, Tsukada Y, Zhang Y. Role of Bmi-1 and Ring1A in H2A ubiquitylation and Hox gene silencing. Mol Cell. 2005 Dec 22;20(6):845-54. doi: 10.1016/j.molcel.2005.12.002.
PubMed 16359901Chiba T, Miyagi S, Saraya A, Aoki R, Seki A, Morita Y, Yonemitsu Y, Yokosuka O, Taniguchi H, Nakauchi H, Iwama A. The polycomb gene product BMI1 contributes to the maintenance of tumor-initiating side population cells in hepatocellular carcinoma. Cancer Res. 2008 Oct 1;68(19):7742-9. doi: 10.1158/0008-5472.CAN-07-5882.
PubMed 18829528Cho JH, Dimri M, Dimri GP. A positive feedback loop regulates the expression of polycomb group protein BMI1 via WNT signaling pathway. J Biol Chem. 2013 Feb 1;288(5):3406-18. doi: 10.1074/jbc.M112.422931. Epub 2012 Dec 13.
PubMed 23239878Costa DB, Li S, Kocher O, Feins RH, Keller SM, Schiller JH, Johnson DH, Tenen DG, Halmos B. Immunohistochemical analysis of C/EBPalpha in non-small cell lung cancer reveals frequent down-regulation in stage II and IIIA tumors: a correlative study of E3590. Lung Cancer. 2007 Apr;56(1):97-103. doi: 10.1016/j.lungcan.2006.11.023. Epub 2007 Jan 18.
PubMed 17239984Douglas D, Hsu JH, Hung L, Cooper A, Abdueva D, van Doorninck J, Peng G, Shimada H, Triche TJ, Lawlor ER. BMI-1 promotes ewing sarcoma tumorigenicity independent of CDKN2A repression. Cancer Res. 2008 Aug 15;68(16):6507-15. doi: 10.1158/0008-5472.CAN-07-6152.
PubMed 18701473Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774Facchino S, Abdouh M, Chatoo W, Bernier G. BMI1 confers radioresistance to normal and cancerous neural stem cells through recruitment of the DNA damage response machinery. J Neurosci. 2010 Jul 28;30(30):10096-111. doi: 10.1523/JNEUROSCI.1634-10.2010.
PubMed 20668194Fan C, He L, Kapoor A, Rybak AP, De Melo J, Cutz JC, Tang D. PTEN inhibits BMI1 function independently of its phosphatase activity. Mol Cancer. 2009 Nov 10;8:98. doi: 10.1186/1476-4598-8-98.
PubMed 19903340Glinsky GV, Berezovska O, Glinskii AB. Microarray analysis identifies a death-from-cancer signature predicting therapy failure in patients with multiple types of cancer. J Clin Invest. 2005 Jun;115(6):1503-21. doi: 10.1172/JCI23412.
PubMed 15931389Guney I, Wu S, Sedivy JM. Reduced c-Myc signaling triggers telomere-independent senescence by regulating Bmi-1 and p16(INK4a). Proc Natl Acad Sci U S A. 2006 Mar 7;103(10):3645-50. doi: 10.1073/pnas.0600069103. Epub 2006 Feb 28.
PubMed 16537449Kreso A, van Galen P, Pedley NM, Lima-Fernandes E, Frelin C, Davis T, Cao L, Baiazitov R, Du W, Sydorenko N, Moon YC, Gibson L, Wang Y, Leung C, Iscove NN, Arrowsmith CH, Szentgyorgyi E, Gallinger S, Dick JE, O'Brien CA. Self-renewal as a therapeutic target in human colorectal cancer. Nat Med. 2014 Jan;20(1):29-36. doi: 10.1038/nm.3418. Epub 2013 Dec 1.
PubMed 24292392Li DW, Tang HM, Fan JW, Yan DW, Zhou CZ, Li SX, Wang XL, Peng ZH. Expression level of Bmi-1 oncoprotein is associated with progression and prognosis in colon cancer. J Cancer Res Clin Oncol. 2010 Jul;136(7):997-1006. doi: 10.1007/s00432-009-0745-7. Epub 2009 Dec 19.
PubMed 20024662
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of PTC596 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02404480
- Acronym / sponsor ID
- PTC596-ONC-001-AST
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PTC TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 31 Mar 2015 (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 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in patients with advanced cancer.
Detailed description
This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic (PK) study of PTC596 in patients with advanced cancer. A variation of the traditional 3+3 dose escalation design will be employed.
PTC596 will be administered orally on a twice a week (biw) schedule. Each 4-week period of drug administration will be considered one cycle. The objective of the study will be to determine the recommended Phase 2 dose (RP2D) and to determine preliminary proof of mechanism of action.
Collectively, data from the Good Laboratory Practice (GLP) and non-GLP studies indicate that 40 mg/kg biw is approximately the severely toxic dose in 10% of animals (STD 10). Therefore, the starting dose in this study will be calculated as one-tenth of the human equivalent dose (HED) of 40 mg/kg biw in rats, which is 0.65 mg/kg biw.
In this study, escalating dose levels will be evaluated to determine the RP2D. Three patients will be enrolled at the starting dose level (0.65 mg/kg biw); if 1 of the 3 patients experiences a dose-limiting toxicity (DLT), an additional 3 patients will be enrolled at the same dose level. Thus, 3 to 6 patients will receive the starting dose level of 0.65 mg/kg. Dose escalation will continue until the occurrence of DLT in ≥2/6 patients at a given dose level. Dose escalation will occur in approximately 100% increments until Grade ≥2, first-cycle toxicity is seen in at least 2 patients across all dose levels, after which dose escalation will occur in smaller (50% or 33%) increments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Open-label, first-in-human, safety and pharmacokinetic (PK)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PTC596PTC 596 administered twice daily- Dose level 0.65mg/kg |
| Cohort 2 | Experimental | Drug: PTC596PTC 596 administered twice daily-Dose level 1.3mg/kg |
| Cohort 3 | Experimental | Drug: PTC596PTC 596 administered twice daily-2.6mg/kg |
| Cohort 4 | Experimental | Drug: PTC596PTC 596 administered twice daily-Dose level 5.2mg/kg |
| Cohort 5 | Experimental | Drug: PTC596PTC 596 administered twice daily-Dose level 10mg/kg |
| Cohort 6 | Experimental | Drug: PTC596PTC 596 administered twice daily-Dose level 7mg/kg |
| Cohort 7 (Bio Marker cohort) | Experimental | Drug: PTC596PTC 596 administered twice daily-Dose level 5.2mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, for which standard curative measures do not exist, that has progressed on at least one line of standard therapy or for which no standard therapies exists
- Discontinuation of all other therapies (including other investigational drugs, radiotherapy, or chemotherapy) for the treatment of cancer ≥4 weeks (≥6 weeks if nitrosoureas, ≥12 weeks if radiotherapy) before initiation of study treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- A measured or estimated creatinine clearance (CrCl) ≥60 mL/min/1.73 m2
Key exclusion criteria (5 listed)
- Prior bone marrow/hematopoietic stem cell transplantation
- History of solid organ, bone marrow, or progenitor cell transplantation
- History of major surgical procedure within 28 days prior to start of study treatment
- Evidence of ongoing systemic bacterial, fungal, or viral infection. Known human immunodeficiency virus (HIV) infection or acquired-immunodeficiency syndrome (AIDS)-related illness
- Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism
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 |
|---|---|---|
| PTC596PTC 596 will be administered orally twice a day until unmanageable toxicity, disease progression, or withdrawal of consent is noted | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 (Bio Marker cohort) |
Primary outcome
Dose-limiting toxicities
Time frame: 28 days
Determine the RP2D based on occurrence of DLTs and/or biological efficacy as determined by biomarker changes.
7 secondary outcomes
Adverse effects
Time frame: 28days
Time to Maximum Plasma Concentration (T max)
Time frame: 28days
Antitumor activity
Time frame: 28days
Maximum Plasma Concentration (C max)
Time frame: 28 days
Plasma Concentration at 24 hours
Time frame: 28days
Area under the plasma concentration-time curve (AUC)
Time frame: 28 days
Terminal half-life (t1/2).
Time frame: 28 days.
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 8 Dec 2017.
- Background: PubMed 19605626Abdouh M, Facchino S, Chatoo W, Balasingam V, Ferreira J, Bernier G. BMI1 sustains human glioblastoma multiforme stem cell renewal. J Neurosci. 2009 Jul 15;29(28):8884-96. doi: 10.1523/JNEUROSCI.0968-09.2009.
- Background: PubMed 16717289American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. doi: 10.1200/JCO.2006.06.9591. Epub 2006 May 22.
- Background: PubMed 24060864Beck B, Blanpain C. Unravelling cancer stem cell potential. Nat Rev Cancer. 2013 Oct;13(10):727-38. doi: 10.1038/nrc3597.
- Background: PubMed 16359901Cao R, Tsukada Y, Zhang Y. Role of Bmi-1 and Ring1A in H2A ubiquitylation and Hox gene silencing. Mol Cell. 2005 Dec 22;20(6):845-54. doi: 10.1016/j.molcel.2005.12.002.
- Background: PubMed 18829528Chiba T, Miyagi S, Saraya A, Aoki R, Seki A, Morita Y, Yonemitsu Y, Yokosuka O, Taniguchi H, Nakauchi H, Iwama A. The polycomb gene product BMI1 contributes to the maintenance of tumor-initiating side population cells in hepatocellular carcinoma. Cancer Res. 2008 Oct 1;68(19):7742-9. doi: 10.1158/0008-5472.CAN-07-5882.
- Background: PubMed 23239878Cho JH, Dimri M, Dimri GP. A positive feedback loop regulates the expression of polycomb group protein BMI1 via WNT signaling pathway. J Biol Chem. 2013 Feb 1;288(5):3406-18. doi: 10.1074/jbc.M112.422931. Epub 2012 Dec 13.
- Background: PubMed 17239984Costa DB, Li S, Kocher O, Feins RH, Keller SM, Schiller JH, Johnson DH, Tenen DG, Halmos B. Immunohistochemical analysis of C/EBPalpha in non-small cell lung cancer reveals frequent down-regulation in stage II and IIIA tumors: a correlative study of E3590. Lung Cancer. 2007 Apr;56(1):97-103. doi: 10.1016/j.lungcan.2006.11.023. Epub 2007 Jan 18.
- Background: PubMed 18701473Douglas D, Hsu JH, Hung L, Cooper A, Abdueva D, van Doorninck J, Peng G, Shimada H, Triche TJ, Lawlor ER. BMI-1 promotes ewing sarcoma tumorigenicity independent of CDKN2A repression. Cancer Res. 2008 Aug 15;68(16):6507-15. doi: 10.1158/0008-5472.CAN-07-6152.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Background: PubMed 20668194Facchino S, Abdouh M, Chatoo W, Bernier G. BMI1 confers radioresistance to normal and cancerous neural stem cells through recruitment of the DNA damage response machinery. J Neurosci. 2010 Jul 28;30(30):10096-111. doi: 10.1523/JNEUROSCI.1634-10.2010.
- Background: PubMed 19903340Fan C, He L, Kapoor A, Rybak AP, De Melo J, Cutz JC, Tang D. PTEN inhibits BMI1 function independently of its phosphatase activity. Mol Cancer. 2009 Nov 10;8:98. doi: 10.1186/1476-4598-8-98.
- Background: PubMed 15931389Glinsky GV, Berezovska O, Glinskii AB. Microarray analysis identifies a death-from-cancer signature predicting therapy failure in patients with multiple types of cancer. J Clin Invest. 2005 Jun;115(6):1503-21. doi: 10.1172/JCI23412.
- BMI1 sustains human glioblastoma multiformae stem cell renewal.Link provided by the sponsor.
- Characterization and Chromosomal localization of the human proto-oncogeneLink provided by the sponsor.
- Human protein atlasLink provided by the sponsor.
- Dose escalation study design exampleLink provided by the sponsor.
- Increased polycomb-group oncogene BMI-1expression coorelates with poor prognosis in Hepatocellular carcinomaLink provided by the sponsor.
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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.
Edward O'Mara, MD study director
PTC Therapeutics
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PTC596 in people with Cancer, run by PTC Therapeutics at 4 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 5 inclusion and 5 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 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.
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?
Dose-limiting toxicities (time frame: 28 days). 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 NCT02404480, which also lists 34 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 8 Dec 2017.