Metastatic Pancreatic AdenocarcinomaPhase 1/2NCT02324543
Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
A Phase 1/2 study testing Gemcitabine, Taxotere and Xeloda in people with Metastatic Pancreatic Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Gemcitabine, Taxotere and Xeloda
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2020
- 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 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
- Have measurable disease.
- Male or non-pregnant and non-lactating female of age >18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 . ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
- Subjects must have adequate organ and marrow function.
- Must use acceptable form of birth control prior to study and and for the duration of study.
- Willing and able to comply with study procedures
Who cannot join
- Patient who have had any prior chemotherapy within 5 years of enrollment.
- Patient who have had radiotherapy for pancreatic cancer.
- Age ≥ 76 years
- Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
- Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
- Patient who has known brain metastases.
Show all 13Show fewer
- Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, cisplatin, or irinotecan.
- Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patient who has serious medical risk factors involving any of the major organ systems.
- Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
- Pregnant or breast feeding.
- Patient is unwilling or unable to comply with study procedures
- Patient with clinically significant wound
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
Official title: Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.
Read the detailed description
The study is being done in 2 parts. The first part is the dose escalation (Phase I) part of the study where the dose of irinotecan is increased until the highest safe dose of irinotecan is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin.
After the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and cisplatin is defined, the second part of the study (Phase 2) will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- Gemcitabine, Taxotere, Xeloda, Cisplatin, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
IV on days 4 and 11 of a 21 day cycle
TaxotereDrug
Also called Docetaxel
IV on days 4 and 11 of a 21 day cycle
XelodaDrug
Also called Capecitabine
Twice a day orally on days 1 through 14 of a 21 day cycle
CisplatinDrug
Also called Platinol
IV on days 4 and 11 of a 21 day cycle
IrinotecanDrug
Also called Camptosar
IV on days 4 and 11 of a 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 - Phase 1 | Experimental | * Gemcitabine - 400 mg/m^2
* Taxotere - 20 mg/m^2
* Xeloda - 500 mg/twice daily (BID)
* Cisplatin - 15 mg/m^2
* Irinotecan - 20 mg/m^2 Receives: Drug: Gemcitabine; Drug: Taxotere; Drug: Xeloda; Drug: Cisplatin; Drug: Irinotecan |
| Dose Level 2 - Phase 1 | Experimental | * Gemcitabine - 400 mg/m^2
* Taxotere - 20 mg/m^2
* Xeloda - 500 mg/BID
* Cisplatin - 15 mg/m^2
* Irinotecan - 40 mg/m^2 Receives: Drug: Gemcitabine; Drug: Taxotere; Drug: Xeloda; Drug: Cisplatin; Drug: Irinotecan |
| Dose Level 3 - Phase 1 | Experimental | * Gemcitabine - 400 mg/m^2
* Taxotere - 20 mg/m^2
* Xeloda - 500 mg/BID
* Cisplatin - 15 mg/m^2
* Irinotecan - 60 mg/m^2 Receives: Drug: Gemcitabine; Drug: Taxotere; Drug: Xeloda; Drug: Cisplatin; Drug: Irinotecan |
| Dose Level 1a - Phase 1 | Experimental | * Gemcitabine - 500 mg/m^2
* Taxotere - 20 mg/m^2
* Xeloda - 500 mg/BID
* Cisplatin - 20 mg/m^2
* Irinotecan - 20 mg/m^2 Receives: Drug: Gemcitabine; Drug: Taxotere; Drug: Xeloda; Drug: Cisplatin; Drug: Irinotecan |
| Dose level 1b - Phase 1 | Experimental | * Gemcitabine - 500 mg/m^2
* Taxotere - 20 mg/m^2
* Xeloda - 500 mg/BID
* Cisplatin - 20 mg/m^2
* Irinotecan - 40 mg/m^2 Receives: Drug: Gemcitabine; Drug: Taxotere; Drug: Xeloda; Drug: Cisplatin; Drug: Irinotecan |
| Phase 2 | Experimental | * Gemcitabine - 500 mg/m^2
* Taxotere - 20 mg/m^2
* Xeloda - 500 mg/BID
* Cisplatin - 20 mg/m^2
* Irinotecan - 20 mg/m^2 Receives: Drug: Gemcitabine; Drug: Taxotere; Drug: Xeloda; Drug: Cisplatin; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Gemcitabine
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.
Measured: 28 days
Maximum Tolerated Dose (MTD) of Docetaxel
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.
Measured: 28 days
Maximum Tolerated Dose (MTD) of Capecitabine
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use.
Measured: 28 days
Maximum Tolerated Dose (MTD) of Cisplatin
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.
Measured: 28 days
Maximum Tolerated Dose (MTD) of Irinotecan
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.
Measured: 28 days
Overall Survival (OS) Rate at 9 Months
OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only)
Measured: 9 months
Secondary outcomes (4)
Response Rate (RR) Using RECIST 1.1 Criteria
RR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Measured: 43 months
Disease Control Rate (DCR) Using RECIST 1.1 Criteria
DCR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Measured: 43 months
Progression-free Survival (PFS) Using RECIST 1.1 Criteria
PFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Measured: 5 years
Overall Survival (OS)
OS will be measured (in months) from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionJun 2019
- Study completionFeb 2020
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 Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Swim Across America
- Responsible party
- Sponsor
- Investigators
- Dung Le, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324543
- Sponsor's protocol ID
- J14161
- Other IDs
- J14161, IRB00053208
- Status last verified
- Jul 2023
- First submitted
- 19 Dec 2014
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Christenson ES, Lim SJ, Durham J, De Jesus-Acosta A, Bever K, Laheru D, Ryan A, Agarwal P, Scharpf RB, Le DT, Wang H. Cell-free DNA Predicts Prolonged Response to Multi-agent Chemotherapy in Pancreatic Ductal Adenocarcinoma. Cancer Res Commun. 2022 Nov 11;2(11):1418-1425. doi: 10.1158/2767-9764.CRC-22-0343. eCollection 2022 Nov.
PubMed 36970054
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02324543
- Acronym / sponsor ID
- J14161
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Swim Across America
- Study start
- Feb 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.
Detailed description
The study is being done in 2 parts. The first part is the dose escalation (Phase I) part of the study where the dose of irinotecan is increased until the highest safe dose of irinotecan is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin.
After the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and cisplatin is defined, the second part of the study (Phase 2) will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 - Phase 1 | Experimental | Drug: Gemcitabine, Drug: Taxotere, Drug: Xeloda, Drug: Cisplatin, Drug: Irinotecan* Gemcitabine - 400 mg/m^2 * Taxotere - 20 mg/m^2 * Xeloda - 500 mg/twice daily (BID) * Cisplatin - 15 mg/m^2 * Irinotecan - 20 mg/m^2 |
| Dose Level 2 - Phase 1 | Experimental | Drug: Gemcitabine, Drug: Taxotere, Drug: Xeloda, Drug: Cisplatin, Drug: Irinotecan* Gemcitabine - 400 mg/m^2 * Taxotere - 20 mg/m^2 * Xeloda - 500 mg/BID * Cisplatin - 15 mg/m^2 * Irinotecan - 40 mg/m^2 |
| Dose Level 3 - Phase 1 | Experimental | Drug: Gemcitabine, Drug: Taxotere, Drug: Xeloda, Drug: Cisplatin, Drug: Irinotecan* Gemcitabine - 400 mg/m^2 * Taxotere - 20 mg/m^2 * Xeloda - 500 mg/BID * Cisplatin - 15 mg/m^2 * Irinotecan - 60 mg/m^2 |
| Dose Level 1a - Phase 1 | Experimental | Drug: Gemcitabine, Drug: Taxotere, Drug: Xeloda, Drug: Cisplatin, Drug: Irinotecan* Gemcitabine - 500 mg/m^2 * Taxotere - 20 mg/m^2 * Xeloda - 500 mg/BID * Cisplatin - 20 mg/m^2 * Irinotecan - 20 mg/m^2 |
| Dose level 1b - Phase 1 | Experimental | Drug: Gemcitabine, Drug: Taxotere, Drug: Xeloda, Drug: Cisplatin, Drug: Irinotecan* Gemcitabine - 500 mg/m^2 * Taxotere - 20 mg/m^2 * Xeloda - 500 mg/BID * Cisplatin - 20 mg/m^2 * Irinotecan - 40 mg/m^2 |
| Phase 2 | Experimental | Drug: Gemcitabine, Drug: Taxotere, Drug: Xeloda, Drug: Cisplatin, Drug: Irinotecan* Gemcitabine - 500 mg/m^2 * Taxotere - 20 mg/m^2 * Xeloda - 500 mg/BID * Cisplatin - 20 mg/m^2 * Irinotecan - 20 mg/m^2 |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
- Have measurable disease.
- Male or non-pregnant and non-lactating female of age >18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 . ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
- Subjects must have adequate organ and marrow function.
Key exclusion criteria (13 listed)
- Patient who have had any prior chemotherapy within 5 years of enrollment.
- Patient who have had radiotherapy for pancreatic cancer.
- Age ≥ 76 years
- Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
- Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
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: GemzarIV on days 4 and 11 of a 21 day cycle | Drug | Dose Level 1a - Phase 1, Dose Level 2 - Phase 1, Dose Level 3 - Phase 1, Dose level 1 - Phase 1, Dose level 1b - Phase 1, Phase 2 |
| TaxotereAlso: DocetaxelIV on days 4 and 11 of a 21 day cycle | Drug | Dose Level 1a - Phase 1, Dose Level 2 - Phase 1, Dose Level 3 - Phase 1, Dose level 1 - Phase 1, Dose level 1b - Phase 1, Phase 2 |
| XelodaAlso: CapecitabineTwice a day orally on days 1 through 14 of a 21 day cycle | Drug | Dose Level 1a - Phase 1, Dose Level 2 - Phase 1, Dose Level 3 - Phase 1, Dose level 1 - Phase 1, Dose level 1b - Phase 1, Phase 2 |
| CisplatinAlso: PlatinolIV on days 4 and 11 of a 21 day cycle | Drug | Dose Level 1a - Phase 1, Dose Level 2 - Phase 1, Dose Level 3 - Phase 1, Dose level 1 - Phase 1, Dose level 1b - Phase 1, Phase 2 |
| IrinotecanAlso: CamptosarIV on days 4 and 11 of a 21 day cycle | Drug | Dose Level 1a - Phase 1, Dose Level 2 - Phase 1, Dose Level 3 - Phase 1, Dose level 1 - Phase 1, Dose level 1b - Phase 1, Phase 2 |
Primary outcome
Maximum Tolerated Dose (MTD) of Gemcitabine
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.
Maximum Tolerated Dose (MTD) of Docetaxel
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.
Maximum Tolerated Dose (MTD) of Capecitabine
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use.
Maximum Tolerated Dose (MTD) of Cisplatin
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.
Maximum Tolerated Dose (MTD) of Irinotecan
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.
Overall Survival (OS) Rate at 9 Months
Time frame: 9 months
OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only)
4 secondary outcomes
Response Rate (RR) Using RECIST 1.1 Criteria
Time frame: 43 months
Disease Control Rate (DCR) Using RECIST 1.1 Criteria
Time frame: 43 months
Progression-free Survival (PFS) Using RECIST 1.1 Criteria
Time frame: 5 years
Overall Survival (OS)
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36970054Christenson ES, Lim SJ, Durham J, De Jesus-Acosta A, Bever K, Laheru D, Ryan A, Agarwal P, Scharpf RB, Le DT, Wang H. Cell-free DNA Predicts Prolonged Response to Multi-agent Chemotherapy in Pancreatic Ductal Adenocarcinoma. Cancer Res Commun. 2022 Nov 11;2(11):1418-1425. doi: 10.1158/2767-9764.CRC-22-0343. eCollection 2022 Nov.
- Individual participant dataSharing planned: No
Related trials for Metastatic Pancreatic Adenocarcinoma
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
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.
Dung Le, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine, Taxotere and Xeloda in people with Metastatic Pancreatic Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 13 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 21 Jul 2023. 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 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 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 14 Sep 2020). 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?
Maximum Tolerated Dose (MTD) of Gemcitabine (time frame: 28 days). The study lists 6 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 NCT02324543, 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 21 Jul 2023.