Biliary Tract Cancer (BTC)Phase 2TELE-ABCNCT03790111
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
A Phase 2 study testing telotristat ethyl in people with Biliary Tract Cancer (BTC), run by TerSera Therapeutics LLC at 14 sites in United States.
Trial summary
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem]) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- telotristat ethyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 14 sitesUnited States
- Study dates
- 13 Mar 2019to 13 Jan 2022
- Phase
- Phase 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults, ≥18 years of age. Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of XERMELO
- Histopathologically or cytologically-confirmed, unresectable, locally advanced, recurrent, or metastatic biliary tract cancer (BTC)
- Naïve to tumor-directed therapy in locally advanced, unresectable, or metastatic setting
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Plans to initiate treatment with 1L therapy (cisplatin plus gemcitabine)
- Ability to provide written informed consent prior to participation in any study-related procedure
Who cannot join
- Prior exposure to XERMELO, telotristat ethyl, telotristat etiprate, LX1032, or LX1606
- Primary tumor site in the ampulla of Vater
- Treatment with photodynamic therapy for localized disease or to relieve biliary obstruction in the presence of metastatic disease within the past 30 days
- Hematology laboratory values of: a. Absolute neutrophil count (ANC) ≤1,500 cells/mm^3; or b. Platelets ≤100,000 cells/mm^3; or c. Hemoglobin (Hgb) ≤9 g/dL; or d. White blood count (WBC) ≤3,000 cells/mm^3
- Hepatic laboratory values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT): a. >5 x upper limit of normal (ULN) if patient has documented history of hepatic metastases; or b. >2.5 x ULN if no liver metastases are present
- Serum albumin <2.8 g/dL
Show all 31Show fewer
- Total bilirubin >1.5 x ULN or >1.5 mg/dL
- Prothrombin time (PT) or international normalized ratio (INR) >1.5 x ULN
- Serum creatinine or serum urea >1.5 x ULN
- Estimated glomerular filtration rate (eGFR) <50 mL/min
- Positive pregnancy test, pregnant, or breastfeeding
- Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study
- Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study
- Myocardial infarction within the past 6 months
- Active bleeding diathesis
- Life expectancy ≤3 months
- Current complaints of persistent constipation or history of chronic constipation, bowel obstruction or fecaloma within the past 6 months
- Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other immunosuppressive agent(s)
- History and/or uncontrolled hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV)-1 or HIV-2
- History of substance or alcohol abuse within the past 2 years
- History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption
- History of malignancy or active treatment for malignancy within 5 years
- Receipt of live, attenuated vaccine or close contact with someone who has received a live, attenuated vaccine within the past 1 month
- Receipt of any investigational agent or study treatment (ie, any treatment or therapy not approved by the FDA for the treatment of BTC) within the past 30 days
- Receipt of any protein or antibody-based therapeutic agents within the past 3 months
- Treatment with any tumor-directed therapy within the past 6 months with curative intent
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might compromise patient safety or the outcome of the study
- Presence of any clinically significant findings (relative to the patient population) during review of medical history or upon physical exam that, in the Investigator's or Medical Monitor's opinion, would compromise patient safety or the outcome of the study
- Evidence of brain metastases
- Unable or unwilling to communicate or cooperate with the Investigator for any reason
- Employee of Sponsor or clinical site, or relative of any member of a clinical site's staff
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
TerSera Investigational Site
Boston, Massachusetts, 02118
TerSera Investigational Site
Buffalo, New York, 14263
TerSera Investigational Site
Charlotte, North Carolina, 28204
TerSera Investigational Site
Chicago, Illinois, 60637
TerSera Investigational Site
Fullerton, California, 92835
TerSera Investigational Site
Gainesville, Florida, 32610
TerSera Investigational Site
Gilbert, Arizona, 85234
TerSera Investigational Site
Grand Rapids, Michigan, 49503
TerSera Investigational Site
Lake Success, New York, 11042
TerSera Investigational Site
Lexington, Kentucky, 40536
TerSera Investigational Site
Oklahoma City, Oklahoma, 73104
TerSera Investigational Site
San Antonio, Texas, 78229
TerSera Investigational Site
Tampa, Florida, 33612
TerSera Investigational Site
Westwood, Kansas, 66205
About this study
Official title: A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
Read the detailed description
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy cis plus gem in patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy in the locally advanced or metastatic setting, and for which treatment with 1L therapy (defined as a combination of cis plus gem) is planned.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- telotristat ethyl
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telotristat ethylDrug
Also called telotristat ethyl + (cisplatin [cis] plus gemcitabine [gem])
XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) three times a day plus first line therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) three times a day plus first line therapy for the duration of the study
| Study group | Role | What they receive |
|---|---|---|
| Xermelo 250mg plus first line therapy for a week, then Xermelo 500mg | Experimental | Xermelo 250 milligram (mg) plus first line therapy for a week, then Xermelo 500mg plus first line therapy for the duration of the study Receives: Drug: telotristat ethyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
Measured: Month 6
Project Overall Survival Rate at Month 6
Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.
Measured: 6 Months
Secondary outcomes (30)
Overall Survival (OS)
Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause.
Measured: First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months
Project Overall Survival Rate at Month 12
Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12.
Measured: 12 Months
Median Progression Free Survival
Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.
Measured: Month 12
Disease Control Rate (DCR), Central Radiologist's Assessment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
Measured: Month 6
Disease Control Rate (DCR), Central Radiologist's Assessment
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
Measured: Month 12
Disease Control Rate (DCR), Central Radiologist's Assessment
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
Measured: End of Study up to 24 months
Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
(CR) + partial response (PR) at Months 6
Measured: Month 6
Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12.
Measured: Month 12
Overall (Objective) Response Rate, Central Radiologist's Assessment
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
Measured: End of Study as defined up to 24 months
Summary of Duration of Progression Free Survival, Local Radiologist's Assessment
Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months.
Measured: up to 7 months
Progression Free Survival, Local Radiologist's Assessment
Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.
Measured: Month 12
Progression Free Survival, Local Radiologist's Assessment
Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study
Measured: End of Study as defined up to 24 months
Overall (Objective) Response Rate, Local Read
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6.
Measured: 6 Months
Overall (Objective) Response Rate, Local Reader's Assessment
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12.
Measured: 12 Months
Overall (Objective) Response Rate (ORR), Local Reader's Assessment
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
Measured: End of Study as defined up to 24 months
Disease Control Rate (DCR), Local Reviewer
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
Measured: Month 12 as defined by 1 year
Disease Control Rate (DCR), Local Reviewer
Disease control rate (DCR), Local Reviewer, 6 Months
Measured: Month 6
Disease Control Rate End of Study, Local Reviewer
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
Measured: End of Study as defined up to 24 months
Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA)
Measured: Month 6
Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA)
Measured: Month 12
Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA)
Measured: End of Study as defined up to 24 months
Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9)
Measured: Month 6
Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9)
Measured: Month 12
Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)
Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9)
Measured: End of Study as defined up to 24 months
Weight Change From Baseline
Mean change in weight at Month 6 from baseline measurement
Measured: Month 6
Weight Change From Baseline
Mean change in weight at Month 12 from baseline measurement
Measured: Month 12
Weight Change From Baseline
Mean change in weight from baseline to End of Study
Measured: End of Study as defined up to 24 months
Change From Baseline in Serum Albumin
Mean change from Baseline to Month 6 serum albumin levels
Measured: Month 6
Change From Baseline in Serum Albumin
Mean change from Baseline to Month 12 serum albumin levels
Measured: Month 12
Change From Baseline in Serum Albumin
Mean change from Baseline to End of Study serum albumin levels
Measured: End of Study as defined up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start13 Mar 2019
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Why it stopped: Did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis
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.
- Other trials for Biliary Tract Cancer (BTC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- TerSera Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renuka Iyer, M.D., Study chair, Roswell Park Cancer InstituteRichard Kim, M.D., Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790111
- Sponsor's protocol ID
- LX1606.1-207-BTC
- Other IDs
- LX1606.207, LX1606.207
- Acronym
- TELE-ABC
- Status last verified
- Apr 2023
- First submitted
- 25 Dec 2018
- Last updated
- 19 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)
- ClinicalTrials.gov ID
- NCT03790111
- Acronym / sponsor ID
- TELE-ABC / LX1606.1-207-BTC
- Conditions
- Biliary Tract Cancer (BTC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis
- Enrolment
- 53 participants (actual)
- Lead sponsor
- TerSera Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Posted 19 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
Detailed description
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy cis plus gem in patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy in the locally advanced or metastatic setting, and for which treatment with 1L therapy (defined as a combination of cis plus gem) is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xermelo 250mg plus first line therapy for a week, then Xermelo 500mg | Experimental | Drug: telotristat ethylXermelo 250 milligram (mg) plus first line therapy for a week, then Xermelo 500mg plus first line therapy for the duration of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female adults, ≥18 years of age. Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of XERMELO
- Histopathologically or cytologically-confirmed, unresectable, locally advanced, recurrent, or metastatic biliary tract cancer (BTC)
- Naïve to tumor-directed therapy in locally advanced, unresectable, or metastatic setting
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (31 listed)
- Prior exposure to XERMELO, telotristat ethyl, telotristat etiprate, LX1032, or LX1606
- Primary tumor site in the ampulla of Vater
- Treatment with photodynamic therapy for localized disease or to relieve biliary obstruction in the presence of metastatic disease within the past 30 days
- Hematology laboratory values of: a. Absolute neutrophil count (ANC) ≤1,500 cells/mm^3; or b. Platelets ≤100,000 cells/mm^3; or c. Hemoglobin (Hgb) ≤9 g/dL; or d. White blood count (WBC) ≤3,000 cells/mm^3
- Hepatic laboratory values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT): a. >5 x upper limit of normal (ULN) if patient has documented history of hepatic metastases; or b. >2.5 x ULN if no liver metastases are present
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 |
|---|---|---|
| telotristat ethylAlso: telotristat ethyl + (cisplatin [cis] plus gemcitabine [gem])XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) three times a day plus first line therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) three times a day plus first line therapy for the duration of the study | Drug | Xermelo 250mg plus first line therapy for a week, then Xermelo 500mg |
Primary outcome
Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment
Time frame: Month 6
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
Project Overall Survival Rate at Month 6
Time frame: 6 Months
Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.
30 secondary outcomes
Overall Survival (OS)
Time frame: First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months
Project Overall Survival Rate at Month 12
Time frame: 12 Months
Median Progression Free Survival
Time frame: Month 12
Disease Control Rate (DCR), Central Radiologist's Assessment
Time frame: Month 6
Disease Control Rate (DCR), Central Radiologist's Assessment
Time frame: Month 12
Disease Control Rate (DCR), Central Radiologist's Assessment
Time frame: End of Study up to 24 months
Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
Time frame: Month 6
Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
Time frame: Month 12
Overall (Objective) Response Rate, Central Radiologist's Assessment
Time frame: End of Study as defined up to 24 months
Summary of Duration of Progression Free Survival, Local Radiologist's Assessment
Time frame: up to 7 months
Progression Free Survival, Local Radiologist's Assessment
Time frame: Month 12
Progression Free Survival, Local Radiologist's Assessment
Time frame: End of Study as defined up to 24 months
Overall (Objective) Response Rate, Local Read
Time frame: 6 Months
Overall (Objective) Response Rate, Local Reader's Assessment
Time frame: 12 Months
Overall (Objective) Response Rate (ORR), Local Reader's Assessment
Time frame: End of Study as defined up to 24 months
Disease Control Rate (DCR), Local Reviewer
Time frame: Month 12 as defined by 1 year
Disease Control Rate (DCR), Local Reviewer
Time frame: Month 6
Disease Control Rate End of Study, Local Reviewer
Time frame: End of Study as defined up to 24 months
Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
Time frame: Month 6
Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
Time frame: Month 12
Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
Time frame: End of Study as defined up to 24 months
Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
Time frame: Month 6
Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
Time frame: Month 12
Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)
Time frame: End of Study as defined up to 24 months
Weight Change From Baseline
Time frame: Month 6
Weight Change From Baseline
Time frame: Month 12
Weight Change From Baseline
Time frame: End of Study as defined up to 24 months
Change From Baseline in Serum Albumin
Time frame: Month 6
Change From Baseline in Serum Albumin
Time frame: Month 12
Change From Baseline in Serum Albumin
Time frame: End of Study as defined up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Renuka Iyer, M.D. study chair
Roswell Park Cancer Institute
Richard Kim, M.D. study chair
H. Lee Moffitt Cancer Center and Research Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing telotristat ethyl in people with Biliary Tract Cancer (BTC), run by TerSera Therapeutics LLC at 14 sites in United States.
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 31 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Apr 2023). 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?
Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment (time frame: Month 6). The study lists 2 primary outcomes in all. 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 19 Apr 2023.