Digestive System NeoplasmsPhase 1NCT04755543
A Study of LP002 for the Treatment of Patients With Malignant Digestive System Neoplasms
A Phase 1 study testing LP002, Cisplatin and Fluorouracil in people with Digestive System Neoplasms, run by Taizhou HoudeAoke Biomedical Co., Ltd. at 6 sites in China.
Trial summary
LP002 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Digestive System Neoplasms
- What is being tested?
- LP002, Cisplatin and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 6 sitesChina
- Study dates
- 17 Jun 2019to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understood and signed an informed consent form.
- Age ≥ 18 and ≤ 75 years old, male or female.
- Has histologically confirmed diagnosis of:
- Malignant digestive system neoplasms (mainly include gastric/ gastroesophageal junction/ esophageal carcinoma) failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment for Arm I-A.
- Malignant gastric/ gastroesophageal junction carcinoma who are PD-L1 positive and failed (experienced progressed disease or unable to tolerate) at least two lines of previously standard treatments for Arm I-B.
- Metastatic gastric carcinoma who are PD-L1 positive and systemic treatment-naive for Arm I-C.
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- Gastric or gastroesophageal junction carcinoma of cT2-4a, any N, M0 who are PD-L1 positive and systemic treatment-naive for Arm I-D.
- Advanced solid tumors (mainly include digestive system neoplasms) who failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment or lack of standard treatments and has suitable lesions for intratumoral injection for Arm I-E.
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
- Life expectancy ≥ 3 months.
- Has at least one measurable extracranial lesion according to RECIST1.1 (except Arm-D).
- Has sufficient organ and bone marrow function to meet the following laboratory examination standards:
- Blood routine: absolute neutrophil count (ANC)≥1.5×10^9/L; while blood cell count (WBC)≥3×10^9/L; platelet count (PLT)≥100×10^9/L;hemoglobin (HGB)≥90 g/L;
- Renal function: Serum creatinine (Scr) ≤1.5×ULN;
- Liver function: TBIL≤1.5×ULN; Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN. Patients with liver metastases require: ALT and AST≤5×ULN;
- The coagulation function is adequate, which is defined as the international normalized ratio (INR) ≤ 2×ULN; or activated partial thromboplastin time (APTT)≤ 1.5×ULN;
- Reproductive men and women of childbearing age are willing to take effective contraceptive measures from signing the informed consent form to 3 months after the last administration of the trial drug.
- Willing to provide tissue samples for PD-L1 biomarker analysis.
Who cannot join
- Suffered from other malignant tumors in the past 5 years，except those with low risk of metastasis and death (5-year survival rate >90%), for instance, skin basal cell carcinoma, squamous cell carcinoma, and carcinoma in situ from cervix or other regions that have been adequately treated);
- Had prior treatment with any anti-programmed cell death-1 (PD-1), or PD-ligand 1 (PD-L1) or CTLA-4 agent or other immune checkpoint inhibition therapies.
- has active or a history (with high chance of recurrence) of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, vasculitis, nephritis, except: Type I Diabetes being treated with fixed dose of insulin, hypothyroidism or Hashimoto's thyroiditis that can be controlled only by hormone replacement therapy, skin diseases that do not require systemic treatment (such as eczema, rash covering <10% body surface area, psoriasis without ocular symptoms).
- Expected to undergo major surgery during the study treatment or within 28 days before the first administration of the study drug.
- Has received systemic corticosteroids or other immunosuppressive drugs within 2 weeks before the first administration of the study drug, excluding:
- Nasal spray, inhalation or other local glucocorticoids.
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- Short-term (≤ 7 days) use of glucocorticoids as a preventive medication for allergic reactions or as a therapeutic medication for non-autoimmune diseases.
- Has active digestive ulcer, incomplete intestinal obstruction, active gastrointestinal hemorrhage or perforation.
- Has active interstitial pneumonia, pulmonary fibrosis, acute pulmonary disorders, acute radiation pneumonitis，et al.
- Has uncontrolled systemic diseases, for instance, cardiovascular and cerebrovascular disease, diabetes, tuberculosis.
- Has a history of HIV infection, or other acquired or innate immune deficiency disorders, or a history of organ or stem-cell transplantation.
- Has active chronic HBV or HCV infection, except those with HBV DNA viral load ≤500 IU/mL or <10^3 copies/mL, or HCV RNA negative after adequate treatment.
- Has severe infection within 4 weeks or active infection requiring IV infusion of antibiotics within 2 weeks prior to the first administration of the study drug.
- Known to be allergic to macromolecular protein agents or monoclonal antibody; Known to has a history of severe allergies to any of the components in the study drug;
- Has participated in other clinical trial within 4 weeks before the first administration of the study drug.
- Alcohol dependence or drug abuse within recent one year.
- Has a history of confirmed neurological or mental disorders, such as epilepsy, dementia; or with poor compliance; or the presence of peripheral neurological disorders.
- Has brain metastasis with symptoms.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
- Other reasons disqualifying the entering of this study based on the evaluation of the investigators.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jing Huang, MD, 010-87788113, huangjing@163.com
- Recruiting
The First Affiliated Hospital. Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310003
Peng Zhao, MD, haozhao@126.com
- Recruiting
The First Affiliated Hospital. Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310003
Qingwei Zhao, M.Pharm, qwzhao@zju.edu.cn
- Recruiting
Liaoning Cancer Hospital & Insititute
Shenyang, Liaoning, 110042
Jingdong Zhang, MD, 13804027878@163.com
- Recruiting
Hubei Cancer Hospital & Insititute
Wuhan, Hubei, 430070
Xinjun Liang, MD, doctorlxj@163.com
- Recruiting
Henan Cancer Hospital & Insititute
Zhengzhou, Henan, 450008
Ying Liu, MD, yaya7207@126.com
About this study
Official title: A Phase I Study of Safety and Pharmacokinetics of LP002 (a Humanized Monoclonal Antibody Targeting PD-L1) in Patients With Malignant Digestive System Neoplasms
LP002 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the safety, pharmacokinetics and preliminary efficacy of LP002 for the treatment of malignant digestive system neoplasms will be evaluated.
- Conditions
- Digestive System Neoplasms
- Being tested
- LP002, Cisplatin, Fluorouracil, OH2 oncolytic virus
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP002Drug
600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W).
CisplatinDrug
50mg/m2 IV on Day 1, Q2W
FluorouracilDrug
2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W
OH2 oncolytic virusBiological
106 or 107 or 108 CCID50/mL by intra-tumoral injection, Q2W
| Study group | Role | What they receive |
|---|---|---|
| I-A | Experimental | LP002 dose escalation (3+3 design): 6-12 patients with malignant digestive system neoplasms (mainly include gastric/ gastroesophageal junction/ esophageal carcinoma) failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment will receive LP002 600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W), for up to 2 year. Receives: Drug: LP002 |
| I-B | Experimental | If the safety profile in Arm A is acceptable, 9-12 patients with malignant gastric/ gastroesophageal junction carcinoma who are PD-L1 positive and failed (experienced progressed disease or unable to tolerate) at least two lines of previously standard treatments will receive LP002 600mg or 900 mg IV on Day 1, Q2W, for up to 2 year. Receives: Drug: LP002 |
| I-C | Experimental | If the safety profile in Arm A is acceptable, 15-20 patients with metastatic gastric carcinoma who are PD-L1 positive and systemic treatment-naive will receive LP002 900 mg IV on Day 1, Q2W, and Cisplatin 50mg/m2 IV on Day 1, Q2W, and Fluorouracil 2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W,for up to 2 year. Receives: Drug: LP002; Drug: Cisplatin; Drug: Fluorouracil |
| I-D | Experimental | Perioperative treatment: If the safety profile in Arm A is acceptable, 15-20 patients with gastric or gastroesophageal junction carcinoma of cT2-4a, any N, M0 who are PD-L1 positive and systemic treatment-naive will receive LP002 900 mg IV on Day 1, Q2W, and Cisplatin 50mg/m2 IV on Day 1, Q2W, and Fluorouracil 2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W, for 3 cycles, 4-6 weeks before operation of the tumor and receive additional 6 cycles of the same therapy 4 weeks after the operation. Receives: Drug: LP002; Drug: Cisplatin; Drug: Fluorouracil |
| I-E | Experimental | Dose escalation (3+3 design) of OH2 (an oncolytic virus) + LP002 900mg：If the safety profile in Arm A is acceptable, 15-30 patients with advanced solid tumors (mainly include digestive system neoplasms) who failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment or lack of standard treatments will receive LP002 900mg IV on Day 1, Q2W, and OH2 10^6 or 10^7 or 10^8 CCID50/mL by intra-tumoral injection, Q2W, for up to 2 year. Receives: Drug: LP002; Biological: OH2 oncolytic virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to approximately 24 months
Secondary outcomes (14)
Objective Response Rate (ORR) for Arm I-A, I-B, I-C, I-E
Percentage of subjects achieving complete response (CR) and partial response (PR).
R0 resection rate RFS pCR
Measured: up to approximately 24 months
Disease Control Rate (DCR) for Arm I-A, I-B, I-C, I-E
Disease Control Rate (DCR) refers to the proportion of subjects who achieve CR, PR and SD through imaging evaluation.
Measured: up to approximately 24 months
Duration of Response (DOR) for Arm I-A, I-B, I-C, I-E
Duration of Response (DOR) is defined as the time from the first evidence of response (PR or CR) to the first evidence of PD or the date of death for any reason.
Measured: up to approximately 24 months
Progression-Free Survival (PFS) for Arm I-A, I-B, I-C, I-E
Progression-free survival (PFS) is defined as the time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.
Measured: up to approximately 24 months
Overall survival (OS) for Arm I-A, I-B, I-C, I-D, I-E
Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause.
Measured: up to approximately 24 months
R0 resection rate for Arm I-D
R0 resection rate refers to the rate of patients who have achieved curative resection of the tumor.(Curative resection refers to the absence of tumor after surgical treatment. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.)
Measured: up to approximately 12 months
pathological complete response rate (pCR rate)
pathological complete response rate (pCR rate) refers to the rate of patients whose tissue samples show no cancer cells left under a microscope after the anti-cancer treatment.
Measured: up to approximately 12 months
Terminal half life of LP002
Measured: up to approximately 12 months
Area under curve of LP002
Measured: up to approximately 12 months
Apparent volume of distribution of LP002
Measured: up to approximately 12 months
Systemic clearance of LP002
Measured: up to approximately 12 months
Cmax of LP002
Measured: up to approximately 12 months
Tmax of LP002
Measured: up to approximately 12 months
Serum concentration of the antibody against LP002 within 1 hour prior to each administration
Measured: up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start17 Jun 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou HoudeAoke Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755543
- Sponsor's protocol ID
- LP002-I-02
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Safety and Pharmacokinetics of LP002 (a Humanized Monoclonal Antibody Targeting PD-L1) in Patients With Malignant Digestive System Neoplasms
- ClinicalTrials.gov ID
- NCT04755543
- Acronym / sponsor ID
- LP002-I-02
- Conditions
- Digestive System Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Taizhou HoudeAoke Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LP002 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the safety, pharmacokinetics and preliminary efficacy of LP002 for the treatment of malignant digestive system neoplasms will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| I-A | Experimental | Drug: LP002LP002 dose escalation (3+3 design): 6-12 patients with malignant digestive system neoplasms (mainly include gastric/ gastroesophageal junction/ esophageal carcinoma) failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment will receive LP002 600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W), for up to 2 year. |
| I-B | Experimental | Drug: LP002If the safety profile in Arm A is acceptable, 9-12 patients with malignant gastric/ gastroesophageal junction carcinoma who are PD-L1 positive and failed (experienced progressed disease or unable to tolerate) at least two lines of previously standard treatments will receive LP002 600mg or 900 mg IV on Day 1, Q2W, for up to 2 year. |
| I-C | Experimental | Drug: LP002, Drug: Cisplatin, Drug: FluorouracilIf the safety profile in Arm A is acceptable, 15-20 patients with metastatic gastric carcinoma who are PD-L1 positive and systemic treatment-naive will receive LP002 900 mg IV on Day 1, Q2W, and Cisplatin 50mg/m2 IV on Day 1, Q2W, and Fluorouracil 2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W,for up to 2 year. |
| I-D | Experimental | Drug: LP002, Drug: Cisplatin, Drug: FluorouracilPerioperative treatment: If the safety profile in Arm A is acceptable, 15-20 patients with gastric or gastroesophageal junction carcinoma of cT2-4a, any N, M0 who are PD-L1 positive and systemic treatment-naive will receive LP002 900 mg IV on Day 1, Q2W, and Cisplatin 50mg/m2 IV on Day 1, Q2W, and Fluorouracil 2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W, for 3 cycles, 4-6 weeks before operation of the tumor and receive additional 6 cycles of the same therapy 4 weeks after the operation. |
| I-E | Experimental | Drug: LP002, Biological: OH2 oncolytic virusDose escalation (3+3 design) of OH2 (an oncolytic virus) + LP002 900mg：If the safety profile in Arm A is acceptable, 15-30 patients with advanced solid tumors (mainly include digestive system neoplasms) who failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment or lack of standard treatments will receive LP002 900mg IV on Day 1, Q2W, and OH2 10^6 or 10^7 or 10^8 CCID50/mL by intra-tumoral injection, Q2W, for up to 2 year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Understood and signed an informed consent form.
- Age ≥ 18 and ≤ 75 years old, male or female.
- Has histologically confirmed diagnosis of:
- Malignant digestive system neoplasms (mainly include gastric/ gastroesophageal junction/ esophageal carcinoma) failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment for Arm I-A.
- Malignant gastric/ gastroesophageal junction carcinoma who are PD-L1 positive and failed (experienced progressed disease or unable to tolerate) at least two lines of previously standard treatments for Arm I-B.
Key exclusion criteria (21 listed)
- Suffered from other malignant tumors in the past 5 years，except those with low risk of metastasis and death (5-year survival rate >90%), for instance, skin basal cell carcinoma, squamous cell carcinoma, and carcinoma in situ from cervix or other regions that have been adequately treated);
- Had prior treatment with any anti-programmed cell death-1 (PD-1), or PD-ligand 1 (PD-L1) or CTLA-4 agent or other immune checkpoint inhibition therapies.
- has active or a history (with high chance of recurrence) of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, vasculitis, nephritis, except: Type I Diabetes being treated with fixed dose of insulin, hypothyroidism or Hashimoto's thyroiditis that can be controlled only by hormone replacement therapy, skin diseases that do not require systemic treatment (such as eczema, rash covering <10% body surface area, psoriasis without ocular symptoms).
- Expected to undergo major surgery during the study treatment or within 28 days before the first administration of the study drug.
- Has received systemic corticosteroids or other immunosuppressive drugs within 2 weeks before the first administration of the study drug, excluding:
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 |
|---|---|---|
| LP002600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W). | Drug | I-A, I-B, I-C, I-D, I-E |
| Cisplatin50mg/m2 IV on Day 1, Q2W | Drug | I-C, I-D |
| Fluorouracil2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W | Drug | I-C, I-D |
| OH2 oncolytic virus106 or 107 or 108 CCID50/mL by intra-tumoral injection, Q2W | Biological | I-E |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to approximately 24 months
14 secondary outcomes
Objective Response Rate (ORR) for Arm I-A, I-B, I-C, I-E
Time frame: up to approximately 24 months
Disease Control Rate (DCR) for Arm I-A, I-B, I-C, I-E
Time frame: up to approximately 24 months
Duration of Response (DOR) for Arm I-A, I-B, I-C, I-E
Time frame: up to approximately 24 months
Progression-Free Survival (PFS) for Arm I-A, I-B, I-C, I-E
Time frame: up to approximately 24 months
Overall survival (OS) for Arm I-A, I-B, I-C, I-D, I-E
Time frame: up to approximately 24 months
R0 resection rate for Arm I-D
Time frame: up to approximately 12 months
pathological complete response rate (pCR rate)
Time frame: up to approximately 12 months
Terminal half life of LP002
Time frame: up to approximately 12 months
Area under curve of LP002
Time frame: up to approximately 12 months
Apparent volume of distribution of LP002
Time frame: up to approximately 12 months
Systemic clearance of LP002
Time frame: up to approximately 12 months
Cmax of LP002
Time frame: up to approximately 12 months
Tmax of LP002
Time frame: up to approximately 12 months
Serum concentration of the antibody against LP002 within 1 hour prior to each administration
Time frame: up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LP002, Cisplatin and Fluorouracil in people with Digestive System Neoplasms, run by Taizhou HoudeAoke Biomedical Co., Ltd. at 6 sites in China.
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 18 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Huang, MD (010-87788113, huangjing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: up to approximately 24 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 16 Feb 2021.