Pancreatic CancerPhase 2NCT01595321
Pancreatic Tumor Cell Vaccine (GVAX), Cyclophosphamide, SBRT, and FOLFIRINOX in Patients With Resected Adenocarcinoma of the Pancreas
A Phase 2 study testing Cyclophosphamide, GVAX Pancreas Vaccine and Stereotactic Body Radiation in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The purpose of this study is to estimate safety of GVAX Pancreas Vaccine (GVAX) with immune modulating doses of cyclophosphamide (Cy) followed by SBRT and FOLFIRINOX chemotherapy in pancreatic cancer patients after surgery. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Cyclophosphamide, GVAX Pancreas Vaccine and Stereotactic Body Radiation
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2012to 18 Oct 2023
- 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 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented cancer of the pancreas (head, neck, and/or uncinate process), that has been completely resected
- No prior Chemotherapy, radiation therapy or biologic therapy for pancreatic cancer
- Must be within 10 weeks from surgical resection of cancer
- Titanium clips (minimum 1) must be placed at the time of surgery to aid in SBRT treatment planning
- ECOG Performance Status of 0 to 1
- Adequate organ function as defined by study-specified laboratory tests
Show all 9Show fewer
- Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
- Signed informed consent form
- Willing and able to comply with study procedures
Who cannot join
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
- Presence of metastatic disease
- Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
- Systemically active steroids
- Chemotherapy, radiation therapy or biologic therapy within 28 days prior to receiving study drug
- Inability to begin protocol treatment within 70 days (10 weeks) after surgery to remove cancer
Show all 9Show fewer
- History of HIV, hepatitis B or C infection
- Pregnant or lactating
- Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
Official title: Pilot Study Evaluating Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX) and Low Dose Cyclophosphamide With Fractionated Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas
The purpose of this study is to estimate safety of GVAX Pancreas Vaccine (GVAX) with immune modulating doses of cyclophosphamide (Cy) followed by SBRT and FOLFIRINOX chemotherapy in pancreatic cancer patients after surgery.
Read the detailed description
This study enrolled patients with surgically resected adenocarcinoma of the pancreas who had titanium clips placed at the time of surgery in order to guide SBRT treatment.
Enrollment was based on traditional 3+3 design with grade 3-4 diarrhea and/or neutropenia defined as the dose limiting toxicity (DLT) within the first 2 cycles (8 weeks) of FOLFIRINOX. The first group of 3 patients (Cohort 1) received SBRT and full dose FOLFIRINOX. The second group of 4 patients (Cohort 2) received SBRT and modified FOLFIRINOX, and the third group of 12 patients (Cohort 3) received SBRT and modified FOLFIRINOX as well as Cy/GVAX vaccinations.
Cy/GVAX (patients 8-19): cyclophosphamide (Cy) at 200 mg/m^2 intravenously over 30 minutes the day before each vaccine. Each vaccination (GVAX) consists of six total intradermal injections of vaccine, two each in the upper right and left thighs, and two in the upper non-dominant arm. Each injection consists of approximately 2.5x10^8 cells of each cell line (PANC 6.03/PANC 10.05) for a total of 5x10^8 cells. The first dose of Cy/GVAX was given within 6-10 weeks from surgery.
Adjuvant SBRT was given 13-17 days after the first dose of Cy/GVAX. Patients receive 5 days of SBRT (6.6 gray (Gy) daily for 33 Gy total) to the tumor bed as delineated by surgical clips placed by the surgeon.
Six 28-day cycles of FOLFIRINOX, starting at least one week after completion of SBRT.
This was permitted to be given locally. Patients were evaluated for dose limiting toxicities (DLTs) within the first 2 cycles (8 weeks).
Cy/GVAX #2-5 was given every 28 days (+/- 3 days), starting 35 days (+/- 7 days) after completion of FOLFIRINOX. Patients without evidence of recurrence could then qualify for additional Cy/GVAX boosts every 6 months (every 12 months with Amendment #10) until disease recurrence, toxicity, withdrawal, or death.
- Conditions
- Pancreatic Cancer
- Being tested
- Cyclophosphamide, GVAX Pancreas Vaccine, Stereotactic Body Radiation, FOLFIRINOX
- Keywords
- Adjuvant therapy, Immunotherapy, Cytoxan, Cyclophosphamide, Pancreatic Vaccine, Stereotactic radiation therapy, SBRT, FOLFIRINOX, GVAX
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan, Cy
Cyclophosphamide (Cy) 200 mg/m^2 administered one day prior to GVAX (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.
GVAX Pancreas VaccineBiological
Also called GVAX, PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
GVAX administered one day after Cy (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.
Stereotactic Body RadiationRadiation
Also called SBRT
Cohort 1 and 2: SBRT (6.6 Gy per day, 33 Gy total dose) will be administered over 5 days within 6-10 weeks of pancreas surgery (Whipple).
Cohort 3: SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX.
FOLFIRINOXDrug
FOLFIRINOX is given over six 28-day cycles, starting at least 1 weeks after SBRT.
FOLFIRINOX consists of the following drugs given IV on days 1 and 15 of each cycle:
Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (400 mg/m^2 bolus followed by 2,400 mg/m^2 continuous infusion over 46-48 hours);
modified FOLFIRINOX consists of the same regimen described above but without the 400 mg/m^2 Fluorouracil bolus.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: SBRT and FOLFIRINOX | Experimental | The initial 3 patients were treated with SBRT and full dose FOLFIRINOX and observed for the first 2 cycles (8 weeks) for dose limiting toxicities (DLTs). If 2-3 patients are observed with uncontrolled grade 3-4 diarrhea, 2-3 patients are observed with grade 3-4 thrombocytopenia, or if 3 patients are observed with grade 3-4 neutropenia within the first 2 cycles of FOLFIRINOX administration (8 weeks) then the dose level will be deemed unacceptable. Receives: Radiation: Stereotactic Body Radiation; Drug: FOLFIRINOX |
| Cohort 2: SBRT and modified FOLFIRINOX | Experimental | The next 4 patients were treated with SBRT and modified FOLFIRINOX and observed for the first 2 cycles (8 weeks) for dose limiting toxicities (DLTs). If no patients are observed with grade 3-4 diarrhea, thrombocytopenia, or neutropenia, then the next cohort of patients will receive SBRT, modified FOLFIRINOX, and GVAX (with Cy). Receives: Radiation: Stereotactic Body Radiation; Drug: FOLFIRINOX |
| Cohort 3: CY, GVAX, SBRT, and modified FOLFIRINOX | Experimental | The last 12 patients will receive Cy, GVAX, SBRT, and modified FOLFIRINOX. Receives: Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine; Radiation: Stereotactic Body Radiation; Drug: FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
The number of participants experiencing grade 3-4 diarrhea, neutropenia, and thrombocytopenia within the first 2 cycles (8 weeks) of treatment, regardless of attribution. The rates of each of these toxicities were considered unacceptable if they were 40%, 60%, and 40%, respectively. A decision rule similar to the traditional 3+3 design was used to determine whether it was safe to continue on to the next cohort.
Measured: 8 weeks
Grade 3 or Higher Cy/GVAX-related Adverse Events
Number of participants with grade 3 or above adverse event attributed to Cy or the GVAX pancreas vaccine. Each adverse event (as defined by NCI CTCAE v4.0) was counted only once for a given subject.
Measured: 116 months
Secondary outcomes (4)
Overall Survival (OS)
OS was measured as the amount of time from date of surgery until death or end of follow-up. OS was 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: 96 months
Disease-free Survival (DFS)
DFS was measured as the time from date of surgery until pancreatic cancer recurrence or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. DFS was censored on the date of last radiologic scan for subjects without documentation of cancer recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Measured: 96 months
Distant Metastases Free Survival (DMFS)
DMFS was measured as the amount of time from date of surgery until metastatic disease progression or death. Metastatic disease progression is the appearance of one or more new lesions outside the primary tumor area (pancreas). Disease status was monitored by radiologic scans done approximately every 12 weeks. DMFS was censored on the date of last radiographic scans for subjects without documentation of metastatic disease progression or death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Measured: 96 months
Freedom From Local Progression (FFLP)
FFLP was measured as the time from date of surgery until disease recurrence in the pancreas or death. Disease status was monitored by radiologic scans done approximately every 12 weeks. FFLP was censored on the date of last radiographic scans for subjects without documentation of local disease recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Measured: 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study start29 Oct 2012
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
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 Pancreatic CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Skip Viragh Foundation
- Responsible party
- Sponsor
- Investigators
- Daniel Laheru, M.D., Principal investigator, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595321
- Sponsor's protocol ID
- J1179
- Other IDs
- NA_00050233
- Status last verified
- Jul 2024
- First submitted
- 27 Apr 2012
- Last updated
- 14 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX) and Low Dose Cyclophosphamide With Fractionated Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT01595321
- Acronym / sponsor ID
- J1179
- Conditions
- Pancreatic Cancer
- Keywords
- Adjuvant therapy, Immunotherapy, Cytoxan, Cyclophosphamide, Pancreatic Vaccine, Stereotactic radiation therapy, SBRT, FOLFIRINOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- The Skip Viragh Foundation
- Study start
- 29 Oct 2012 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to estimate safety of GVAX Pancreas Vaccine (GVAX) with immune modulating doses of cyclophosphamide (Cy) followed by SBRT and FOLFIRINOX chemotherapy in pancreatic cancer patients after surgery.
Detailed description
This study enrolled patients with surgically resected adenocarcinoma of the pancreas who had titanium clips placed at the time of surgery in order to guide SBRT treatment.
Enrollment was based on traditional 3+3 design with grade 3-4 diarrhea and/or neutropenia defined as the dose limiting toxicity (DLT) within the first 2 cycles (8 weeks) of FOLFIRINOX. The first group of 3 patients (Cohort 1) received SBRT and full dose FOLFIRINOX. The second group of 4 patients (Cohort 2) received SBRT and modified FOLFIRINOX, and the third group of 12 patients (Cohort 3) received SBRT and modified FOLFIRINOX as well as Cy/GVAX vaccinations.
Cy/GVAX (patients 8-19): cyclophosphamide (Cy) at 200 mg/m^2 intravenously over 30 minutes the day before each vaccine. Each vaccination (GVAX) consists of six total intradermal injections of vaccine, two each in the upper right and left thighs, and two in the upper non-dominant arm. Each injection consists of approximately 2.5x10^8 cells of each cell line (PANC 6.03/PANC 10.05) for a total of 5x10^8 cells. The first dose of Cy/GVAX was given within 6-10 weeks from surgery.
Adjuvant SBRT was given 13-17 days after the first dose of Cy/GVAX. Patients receive 5 days of SBRT (6.6 gray (Gy) daily for 33 Gy total) to the tumor bed as delineated by surgical clips placed by the surgeon.
Six 28-day cycles of FOLFIRINOX, starting at least one week after completion of SBRT.
This was permitted to be given locally. Patients were evaluated for dose limiting toxicities (DLTs) within the first 2 cycles (8 weeks).
Cy/GVAX #2-5 was given every 28 days (+/- 3 days), starting 35 days (+/- 7 days) after completion of FOLFIRINOX. Patients without evidence of recurrence could then qualify for additional Cy/GVAX boosts every 6 months (every 12 months with Amendment #10) until disease recurrence, toxicity, withdrawal, or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: SBRT and FOLFIRINOX | Experimental | Radiation: Stereotactic Body Radiation, Drug: FOLFIRINOXThe initial 3 patients were treated with SBRT and full dose FOLFIRINOX and observed for the first 2 cycles (8 weeks) for dose limiting toxicities (DLTs). If 2-3 patients are observed with uncontrolled grade 3-4 diarrhea, 2-3 patients are observed with grade 3-4 thrombocytopenia, or if 3 patients are observed with grade 3-4 neutropenia within the first 2 cycles of FOLFIRINOX administration (8 weeks) then the dose level will be deemed unacceptable. |
| Cohort 2: SBRT and modified FOLFIRINOX | Experimental | Radiation: Stereotactic Body Radiation, Drug: FOLFIRINOXThe next 4 patients were treated with SBRT and modified FOLFIRINOX and observed for the first 2 cycles (8 weeks) for dose limiting toxicities (DLTs). If no patients are observed with grade 3-4 diarrhea, thrombocytopenia, or neutropenia, then the next cohort of patients will receive SBRT, modified FOLFIRINOX, and GVAX (with Cy). |
| Cohort 3: CY, GVAX, SBRT, and modified FOLFIRINOX | Experimental | Drug: Cyclophosphamide, Biological: GVAX Pancreas Vaccine, Radiation: Stereotactic Body Radiation, Drug: FOLFIRINOXThe last 12 patients will receive Cy, GVAX, SBRT, and modified FOLFIRINOX. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Documented cancer of the pancreas (head, neck, and/or uncinate process), that has been completely resected
- No prior Chemotherapy, radiation therapy or biologic therapy for pancreatic cancer
- Must be within 10 weeks from surgical resection of cancer
- Titanium clips (minimum 1) must be placed at the time of surgery to aid in SBRT treatment planning
- ECOG Performance Status of 0 to 1
Key exclusion criteria (9 listed)
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
- Presence of metastatic disease
- Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
- Systemically active steroids
- Chemotherapy, radiation therapy or biologic therapy within 28 days prior to receiving study drug
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 |
|---|---|---|
| CyclophosphamideAlso: Cytoxan, CyCyclophosphamide (Cy) 200 mg/m^2 administered one day prior to GVAX (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence. | Drug | Cohort 3: CY, GVAX, SBRT, and modified FOLFIRINOX |
| GVAX Pancreas VaccineAlso: GVAX, PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccineGVAX administered one day after Cy (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence. | Biological | Cohort 3: CY, GVAX, SBRT, and modified FOLFIRINOX |
| Stereotactic Body RadiationAlso: SBRTCohort 1 and 2: SBRT (6.6 Gy per day, 33 Gy total dose) will be administered over 5 days within 6-10 weeks of pancreas surgery (Whipple). Cohort 3: SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX. | Radiation | Cohort 1: SBRT and FOLFIRINOX, Cohort 2: SBRT and modified FOLFIRINOX, Cohort 3: CY, GVAX, SBRT, and modified FOLFIRINOX |
| FOLFIRINOXFOLFIRINOX is given over six 28-day cycles, starting at least 1 weeks after SBRT. FOLFIRINOX consists of the following drugs given IV on days 1 and 15 of each cycle: Oxaliplatin (85 mg/m^2), Irinotecan (180 mg/m^2), Leucovorin (400 mg/m^2), Fluorouracil (400 mg/m^2 bolus followed by 2,400 mg/m^2 continuous infusion over 46-48 hours); modified FOLFIRINOX consists of the same regimen described above but without the 400 mg/m^2 Fluorouracil bolus. | Drug | Cohort 1: SBRT and FOLFIRINOX, Cohort 2: SBRT and modified FOLFIRINOX, Cohort 3: CY, GVAX, SBRT, and modified FOLFIRINOX |
Primary outcome
Dose Limiting Toxicities
Time frame: 8 weeks
The number of participants experiencing grade 3-4 diarrhea, neutropenia, and thrombocytopenia within the first 2 cycles (8 weeks) of treatment, regardless of attribution. The rates of each of these toxicities were considered unacceptable if they were 40%, 60%, and 40%, respectively. A decision rule similar to the traditional 3+3 design was used to determine whether it was safe to continue on to the next cohort.
Grade 3 or Higher Cy/GVAX-related Adverse Events
Time frame: 116 months
Number of participants with grade 3 or above adverse event attributed to Cy or the GVAX pancreas vaccine. Each adverse event (as defined by NCI CTCAE v4.0) was counted only once for a given subject.
4 secondary outcomes
Overall Survival (OS)
Time frame: 96 months
Disease-free Survival (DFS)
Time frame: 96 months
Distant Metastases Free Survival (DMFS)
Time frame: 96 months
Freedom From Local Progression (FFLP)
Time frame: 96 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel Laheru, M.D. principal investigator
The 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 2 study testing Cyclophosphamide, GVAX Pancreas Vaccine and Stereotactic Body Radiation in people with Pancreatic Cancer, 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 9 inclusion and 9 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 14 Aug 2024. 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 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 14 Aug 2024). 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?
Dose Limiting Toxicities (time frame: 8 weeks). 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 14 Aug 2024.