Small Cell Lung CancerPhase 2NCT00617409
To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic Acid
A Phase 2 study testing Paclitaxel, Drug: Ad.p53-DC vaccines and All -trans Retinoic Acid (ATRA) in people with Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this research study is to test a tumor (cancer) vaccine given along with chemotherapy to determine if this vaccine will increase the chances of the tumor shrinking and/or the amount of time that people who have this disease will live. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Paclitaxel, Drug: Ad.p53-DC vaccines and All -trans Retinoic Acid (ATRA)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2007to 31 Jan 2019
- 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
- Patients must have a histological confirmed diagnosis of Small Cell Lung Cancer (SCLC)
- Must have extensive stage SCLC
- Must have completed first line chemotherapy: 4-6 cycles of a standard platinum/etoposide regimen and PCI if chosen at the discretion of the treating Oncologist
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Acceptable (adequate) organ function including:
- White blood count (WBC) >2,500/mm³ and Absolute neutrophil count (ANC) >1,200/mm³
Show all 15Show fewer
- Platelets > 75,000/mm³
- Hematocrit > 24% OR Hemoglobin ≥8.5g/dl
- Bilirubin < 2.0 mg/dl
- Creatinine < 2.0 mg/dl
- Aspartic transaminase (AST/SGOT) ≤2 x upper limit of normal (ULN)
- Alkaline phosphatase ≤3 x ULN
- Patients must have achieved responsive or non-progressive disease status (stable disease [SD], partial response [PR], or complete response [CR]) assessed 4-6 weeks after the last cycle of first line chemotherapy. SD, PR or CR may be confirmed after completion of prophylactic cranial irradiation (PCI) at the discretion of the principal investigator (PI) after discussion with the treating oncologist.
- Males and Females of reproductive potential must agree to use effective contraception during the study and for at least 4 weeks after the last dose of ATRA. Patients are instructed and agree to notify the principal investigator should a pregnancy occur for themselves or their partner.
- Willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study
Who cannot join
- Patients with severe, uncontrolled intercurrent illness or infection
- Anticipated requirement for systemic chronic steroid use at the time of vaccination, unless specifically indicated for dose supplementation or replacement of established corticosteroid insufficiency
- Receiving systemic doses of corticosteroids should have them discontinued ≥ 2 weeks prior to starting vaccination (this include patients receiving steroids with PCI). Inhaled steroids should also be discontinued if at all possible. Chronic, stable doses of inhaled steroids for the treatment of chronic obstructive pulmonary disease (COPD), etc. are allowed if in the opinion of the treating physician(s) they cannot be stopped.
- Any pre-existing immunodeficiency condition, or a known history of human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
- Uncontrolled and/or symptomatic central nervous system (CNS) metastasis
- Pregnant or lactating women. A pregnancy test-serum Beta human chorionic gonadotropin (bHCG) will be obtained during the screening process.
Show all 42Show fewer
- Have received any chemotherapy other than the first line chemotherapy specified in the study protocol: standard platinum/etoposide regimen
- Have received any prior investigational drugs including immunotherapy, gene therapy, hormone therapy, biologic therapy for treatment of SCLC
- Any known pre-existing autoimmune disorder
- History of a second malignancy within the previous 3 years. Exceptions include: non-melanoma skin cancers, any in-situ carcinomas and successfully treated early stage malignancies without evidence of recurrence for > 18 months.
- Have not recovered from any chemotherapy-related or other therapy-related toxicity at study entry
- Have had major surgery without full recovery or major surgery within 3 weeks of the start of vaccine treatment
- Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study
- Pre-Pheresis Criteria:
- Patients must have had a successful harvest of peripheral blood mononuclear cell (PBMC) with leukopheresis at least 6-10 weeks after chemotherapy.
- ECOG performance status of 0-2
- The last dose of first line chemotherapy must have been administered at least 4 weeks prior to the first vaccine administration.
- Patients who received radiation therapy: last dose of radiation must have been completed at least 2 weeks prior to the first vaccine administration and the patient must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia)
- Patients who received steroid therapy: last steroid dose must have been given at least 2 weeks prior to the first vaccine administration
- Adequate organ function:
- WBC > 2,500/mm³ and ANC >1,200/mm³
- Platelets > 75,000/mm³
- Hematocrit > 25%
- Hemoglobin ≥9g/dl
- Bilirubin < 2.0 mg/dl
- Creatinine < 2.0 mg/dL
- AST/SGOT ≤ 2 x ULN
- Alkaline phosphatase < 3 x ULN
- Patients must have signed informed consent at initial registration.
- HLA-A*0201 Testing as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen, however this result will not be an inclusion criterion
- Pre-Paclitaxel Eligibility:
- Progressive disease after observation (Arm A) or vaccinations (Arms B and C)
- ECOG performance status of 0-2
- Adequate organ function:
- WBC > 2,500/mm³ and ANC >1,200/mm³
- Platelets > 75,000/mm³
- Hematocrit > 25%
- Hemoglobin ≥9g/dl
- Bilirubin < 2.0 mg/dl
- Creatinine < 2.0 mg/dL
- AST/SGOT ≤ 2 x ULN
- Alkaline phosphatase < 3 x ULN
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Randomized Phase II Trial Using Dendritic Cells Transduced With an Adenoviral Vector Containing the p53 Gene to Immunize Patients With Extensive Stage Small Cell Lung Cancer in Combination With Chemotherapy With or Without All Trans Retinoic Acid
The purpose of this research study is to test a tumor (cancer) vaccine given along with chemotherapy to determine if this vaccine will increase the chances of the tumor shrinking and/or the amount of time that people who have this disease will live.
Read the detailed description
After initial diagnosis patients will be treated with a standard platinum/etoposide regimen. This standard first-line chemotherapy may/will be administered to patients under the direction of their primary medical oncologist inside or outside of the Moffitt Cancer Center. Patients will receive the platinum drug on day 1 and etoposide on days 1-3 of each 21-day cycle for 4-6 cycles. Patients who have progressive disease (PD) at this point are changed to second line chemotherapy, and will not be eligible to participate in this clinical trial. Patients who achieve a complete response (CR), partial response (PR), or stable disease (SD) after standard first-line chemotherapy will be enrolled. Radiographic studies and tumor measurements are repeated 3-6 weeks after the last dose of chemotherapy (+/- PCI) and may be repeated after prophylactic cranial irradiation (PCI) at the discretion of the principal investigator (PI) and treating physician.
PCI will be permitted at the discretion of the treating oncologist(s). The initial radiation consultation and simulation should occur as soon as the final staging has occurred. Ideally, treatment should commence 1-2 weeks after final staging has been confirmed and will be administered in 10-15 fractions over a 2-3 week period, as recommended by the treating radiation oncologist. Although steroid use is not prohibited, it is recommended and preferred that they not be used during PCI (steroids will have to be discontinued ≥ 2 weeks before first vaccination). PCI can also be considered between vaccines #4 and #5 or vaccine #5 and #6 in those patients eligible for the second course of vaccinations. Systemic dose of steroids will NOT be allowed in these cases unless strictly necessary and after discussion with the PI.
Patients who achieve CR, PR or SD after the completion of first line chemotherapy +/- PCI will be screened for initial registration. Screening tests and procedures will be performed approximately 4-6 weeks after the completion of first line chemotherapy or 6-9 weeks after completion of PCI. Ideally, screening should be completed 1-2 weeks prior to leukopheresis.
Patients who successfully complete the screening exams for initial registration will be randomized into one of three study arms.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Paclitaxel, Drug: Ad.p53-DC vaccines, All -trans Retinoic Acid (ATRA)
- Keywords
- SCLC, vaccine, immunize
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Antitumor agent, Chemotherapy
All groups wil receive paclitaxel as second line chemotherapy if their cancer spreads. At any point when a patient develops evidence of progressive disease, the patient will be treated with second-line chemotherapy. Paclitaxel will be given at a dose of 200 mg/m² on day 1 of 21 day cycles.
Drug: Ad.p53-DC vaccinesBiological
Also called INGN 225
Patients randomized to Arm B will receive vaccinations on 3 occasions, at 2 week intervals. 1-5x106 p53 positive DCs in 1 ml will be injected intradermally into 4 separate sites (0.25 ml injected at each site), in bilateral proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins). Patients will be restaged approximately 2-3 weeks after vaccine # 3 (first vaccine course). If patients show no sign of disease progression at restaging, then a second leukopheresis will be performed. Patients will then be vaccinated 3 more times (second vaccine course) at 4-week intervals, for a total of 6 possible vaccines. Restaging will occur 2-4 weeks after completing the second vaccine course. Patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day).
All -trans Retinoic Acid (ATRA)Drug
Also called tretinoin, Vesanoid, INGN 225
The patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy Receives: Drug: Paclitaxel |
| Ad.p53-DC Vaccines | Experimental | Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy Receives: Drug: Paclitaxel; Biological: Drug: Ad.p53-DC vaccines |
| Ad.p53-DC Vaccines + ATRA | Experimental | Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemotherapy Receives: Drug: Paclitaxel; Biological: Drug: Ad.p53-DC vaccines; Drug: All -trans Retinoic Acid (ATRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate (RR)
Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: 12 months
Secondary outcomes (1)
Overall Survival (OS)
To evaluate the survival of all patients enrolled on an intent-to-treat basis. Overall survival per treatment arm.
Measured: 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 posted18 Feb 2008 (estimated)
- Study start2 Oct 2007
- Primary completion21 Sep 2015
- Study completion31 Jan 2019
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 Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Antonia, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617409
- Sponsor's protocol ID
- MCC-15206
- Other IDs
- 105790, 0147NE, 0705-857
- Status last verified
- Nov 2019
- First submitted
- 5 Feb 2008
- Last updated
- 8 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Using Dendritic Cells Transduced With an Adenoviral Vector Containing the p53 Gene to Immunize Patients With Extensive Stage Small Cell Lung Cancer in Combination With Chemotherapy With or Without All Trans Retinoic Acid
- ClinicalTrials.gov ID
- NCT00617409
- Acronym / sponsor ID
- MCC-15206
- Conditions
- Small Cell Lung Cancer
- Keywords
- SCLC, vaccine, immunize
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 2 Oct 2007 (actual)
- Primary completion
- 21 Sep 2015 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Posted 1 Nov 2016
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 research study is to test a tumor (cancer) vaccine given along with chemotherapy to determine if this vaccine will increase the chances of the tumor shrinking and/or the amount of time that people who have this disease will live.
Detailed description
After initial diagnosis patients will be treated with a standard platinum/etoposide regimen. This standard first-line chemotherapy may/will be administered to patients under the direction of their primary medical oncologist inside or outside of the Moffitt Cancer Center. Patients will receive the platinum drug on day 1 and etoposide on days 1-3 of each 21-day cycle for 4-6 cycles. Patients who have progressive disease (PD) at this point are changed to second line chemotherapy, and will not be eligible to participate in this clinical trial. Patients who achieve a complete response (CR), partial response (PR), or stable disease (SD) after standard first-line chemotherapy will be enrolled. Radiographic studies and tumor measurements are repeated 3-6 weeks after the last dose of chemotherapy (+/- PCI) and may be repeated after prophylactic cranial irradiation (PCI) at the discretion of the principal investigator (PI) and treating physician.
PCI will be permitted at the discretion of the treating oncologist(s). The initial radiation consultation and simulation should occur as soon as the final staging has occurred. Ideally, treatment should commence 1-2 weeks after final staging has been confirmed and will be administered in 10-15 fractions over a 2-3 week period, as recommended by the treating radiation oncologist. Although steroid use is not prohibited, it is recommended and preferred that they not be used during PCI (steroids will have to be discontinued ≥ 2 weeks before first vaccination). PCI can also be considered between vaccines #4 and #5 or vaccine #5 and #6 in those patients eligible for the second course of vaccinations. Systemic dose of steroids will NOT be allowed in these cases unless strictly necessary and after discussion with the PI.
Patients who achieve CR, PR or SD after the completion of first line chemotherapy +/- PCI will be screened for initial registration. Screening tests and procedures will be performed approximately 4-6 weeks after the completion of first line chemotherapy or 6-9 weeks after completion of PCI. Ideally, screening should be completed 1-2 weeks prior to leukopheresis.
Patients who successfully complete the screening exams for initial registration will be randomized into one of three study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: PaclitaxelArm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy |
| Ad.p53-DC Vaccines | Experimental | Drug: Paclitaxel, Biological: Drug: Ad.p53-DC vaccinesArm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy |
| Ad.p53-DC Vaccines + ATRA | Experimental | Drug: Paclitaxel, Biological: Drug: Ad.p53-DC vaccines, Drug: All -trans Retinoic Acid (ATRA)Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have a histological confirmed diagnosis of Small Cell Lung Cancer (SCLC)
- Must have extensive stage SCLC
- Must have completed first line chemotherapy: 4-6 cycles of a standard platinum/etoposide regimen and PCI if chosen at the discretion of the treating Oncologist
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Acceptable (adequate) organ function including:
Key exclusion criteria (42 listed)
- Patients with severe, uncontrolled intercurrent illness or infection
- Anticipated requirement for systemic chronic steroid use at the time of vaccination, unless specifically indicated for dose supplementation or replacement of established corticosteroid insufficiency
- Receiving systemic doses of corticosteroids should have them discontinued ≥ 2 weeks prior to starting vaccination (this include patients receiving steroids with PCI). Inhaled steroids should also be discontinued if at all possible. Chronic, stable doses of inhaled steroids for the treatment of chronic obstructive pulmonary disease (COPD), etc. are allowed if in the opinion of the treating physician(s) they cannot be stopped.
- Any pre-existing immunodeficiency condition, or a known history of human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
- Uncontrolled and/or symptomatic central nervous system (CNS) metastasis
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 |
|---|---|---|
| PaclitaxelAlso: Antitumor agent, ChemotherapyAll groups wil receive paclitaxel as second line chemotherapy if their cancer spreads. At any point when a patient develops evidence of progressive disease, the patient will be treated with second-line chemotherapy. Paclitaxel will be given at a dose of 200 mg/m² on day 1 of 21 day cycles. | Drug | Ad.p53-DC Vaccines, Ad.p53-DC Vaccines + ATRA, Standard of Care |
| Drug: Ad.p53-DC vaccinesAlso: INGN 225Patients randomized to Arm B will receive vaccinations on 3 occasions, at 2 week intervals. 1-5x106 p53 positive DCs in 1 ml will be injected intradermally into 4 separate sites (0.25 ml injected at each site), in bilateral proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins). Patients will be restaged approximately 2-3 weeks after vaccine # 3 (first vaccine course). If patients show no sign of disease progression at restaging, then a second leukopheresis will be performed. Patients will then be vaccinated 3 more times (second vaccine course) at 4-week intervals, for a total of 6 possible vaccines. Restaging will occur 2-4 weeks after completing the second vaccine course. Patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day). | Biological | Ad.p53-DC Vaccines, Ad.p53-DC Vaccines + ATRA |
| All -trans Retinoic Acid (ATRA)Also: tretinoin, Vesanoid, INGN 225The patients in Arm C will receive vaccines at the same dose and schedule as described for patients in Arm B. In addition, they will receive 150 mg/m² of ATRA for 3 days prior to each vaccine administration (followed by vaccine administration on the fourth day). | Drug | Ad.p53-DC Vaccines + ATRA |
Primary outcome
Tumor Response Rate (RR)
Time frame: 12 months
Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
1 secondary outcome
Overall Survival (OS)
Time frame: 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 8 Nov 2019.
- 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.
Scott Antonia, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 Paclitaxel, Drug: Ad.p53-DC vaccines and All -trans Retinoic Acid (ATRA) in people with Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute 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 15 inclusion and 42 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 Nov 2019. 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 1 Nov 2016). 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?
Tumor Response Rate (RR) (time frame: 12 months). 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 8 Nov 2019.