Chronic Lymphocytic LeukemiaPhase 1NCT02222688
UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 1 study testing cirmtuzumab in people with Chronic Lymphocytic Leukemia, run by Thomas Kipps at 1 site in United States.
Trial summary
The purpose of the study is to investigate the safety of the investigational agent, cirmtuzumab. Cirmtuzumab is a monoclonal antibody drug designed to attach to a protein, called ROR1, on the surface of chronic lymphocytic leukemia (CLL) cells to block cell growth and survival. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- cirmtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2014to 1 May 2018
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and phenotypic verification of B cell CLL and measurable disease. Immunophenotyping of the leukemic cells must demonstrate a monoclonal B cell population with immunophenotype consistent with CLL.
- Relapsed or refractory disease, defined by failure to achieve a partial response within 6 months of initiation of therapy, or a 50% increase of baseline disease measurements after achieving a clinical response.
- Not amenable to approved therapies.
- Prior Therapy: Must have progressed after purine-analog or alkylator based therapy, or be considered inappropriate for chemo-immunotherapy due to one of the following:
- Del 17p, which is associated with poor response to chemo-immunotherapy, or
- Age greater than 70, or
Show all 27Show fewer
- Age greater than 65 with one of the following:
- Grade ≥ 3 neutropenia, anemia, or thrombocytopenia attributable to cumulative myelotoxicity from prior administration of cytotoxic agents (as documented by bone marrow biopsy obtained since last prior therapy), or
- Clinically apparent autoimmune cytopenia which may be exacerbated by fludarabine therapy, or
- Estimated creatinine clearance (eCCr) <70 mL/min (as determined by the Cockcroft-Gault method), or
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 0.
- Has recovered from the toxic effects of prior therapy to their clinical baseline.
- Women of childbearing potential must agree not to become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of cirmtuzumab.
- Subjects must have at least one of the following indications for treatment:
- Symptomatic or progressive splenomegaly;
- Symptomatic lymph nodes, nodal clusters, or progressive lymphadenopathy;
- Progressive anemia (hemoglobin ≤ 11 g/dL);
- Progressive thrombocytopenia (platelets ≤ 100 x 10^9/L);
- Weight loss > 10% body weight over the preceding 6 month period;
- Fatigue attributable to CLL;
- Fever or night sweats for > 2 weeks without evidence of infection;
- Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of less than 12 months.
- Subjects must have an ECOG performance status of 0-2.
- Adequate hematologic function
- Adequate renal function
- Adequate hepatic function
- Adequate coagulation tests
Who cannot join
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
- Patients who are currently receiving another investigational agent are excluded.
- Patients who have had chemotherapy (e.g., purine analogues, alkylating agents), immunotherapy, radiation therapy, or participation in any investigational drug treatment within 4 weeks of initiation of UC-961 or at any time during the study.
- Patients who have had prior (within 8 weeks of initiation of UC-961) or concurrent antibody therapy directed against CLL (i.e., Rituxan® and Campath®).
- Current infection requiring parenteral antibiotics.
- Active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
Show all 16Show fewer
- Concurrent malignancy or prior malignancy within the previous 3 years (other than completely resected carcinoma in situ, prostate cancer, or localized non-melanoma skin cancer).
- Known central nervous system (CNS) involvement by malignancy.
- Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
- Uncompensated hypothyroidism (defined as thyroid-stimulating hormone (TSH) greater than 2x upper limit of normal not treated with replacement hormone).
- Presence of more than 55% pro-lymphocytes in peripheral blood. Patients with Richter's transformation are not excluded.
- Insufficient recovery from surgical-related trauma or wound healing.
- Impaired cardiac function including any of the following:
- Myocardial infarction within 6 months of starting study drug;
- A past medical history of clinically significant ECG abnormalities, including QTc 481 milliseconds or greater;
- Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: A Phase I Clinical Trial to Determine the Safety and Tolerability of UC-961 (Cirmtuzumab), an Anti-ROR1 Monoclonal Antibody, for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Are Ineligible for Chemotherapy
The purpose of the study is to investigate the safety of the investigational agent, cirmtuzumab. Cirmtuzumab is a monoclonal antibody drug designed to attach to a protein, called ROR1, on the surface of chronic lymphocytic leukemia (CLL) cells to block cell growth and survival. ROR1 is rarely expressed on healthy cells so the idea is to preferentially get rid of the cancer cells. Although there is evidence in laboratory animals that cirmtuzumab can decrease the number of CLL cells, the investigators do not know if this will work in humans. This drug will be given to humans for the first time in this study. Therefore, the goal of this study is to see if cirmtuzumab is safe and tolerated in study participants.
Read the detailed description
This is a first in human, open-label single institution, Phase I dose escalation study of in patients with relapsed or refractory CLL. Treatment cycle (14 days) will consist of cirmtuzumab administered intravenously on a bi-weekly (every two weeks) schedule for a total of 4 doses. Eight dose cohorts (of 3 to 6 patients in size) plus an expansion cohort of 6 patients are planned. In the first 4 dose cohorts, there is intra-patient dose escalation to monitor for acute toxicities, such as tumor lysis syndrome.
A cycle may be repeated every 14 days if the patient has at least stable disease by clinical examination (or interim response assessment) and has again met hematologic, renal, and hepatic laboratory parameters as defined in the eligibility section, and is without ongoing Grade 3 non-hematologic or Grade 4 hematologic toxicities attributable to cirmtuzumab. The total duration of study drug administration is 4 cycles. Each cycle consists of clinical and laboratory evaluation on Day 1 and safety assessments on Days 3 and 8.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- cirmtuzumab
- Keywords
- cancer, CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cirmtuzumabDrug
Also called UC-961
| Study group | Role | What they receive |
|---|---|---|
| Cirmtuzumab 0.015 - 0.03 mg/kg | Experimental | Cohort 1: Cirmtuzumab 0.015 mg/kg for two 14-day cycles followed by cirmtuzumab 0.03 mg/kg for two 14-day cycles via intravenous (IV) infusion Receives: Drug: cirmtuzumab |
| Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | Experimental | Cohort 2: Cirmtuzumab 0.06 mg/kg for one 14-day cycle, followed by cirmtuzumab 0.12 mg/kg for one 14-day cycle, followed by 0.24 mg/kg for two 14-day cycles via IV infusion Receives: Drug: cirmtuzumab |
| Cirmtuzumab 0.5 - 1.0 mg/kg | Experimental | Cohort 3: Cirmtuzumab 0.5 mg/kg for one 14-day cycle, followed by cirmtuzumab 1.0 mg/kg for three 14-day cycles via IV infusion Receives: Drug: cirmtuzumab |
| Cirmtuzumab 2.0 - 4.0 mg/kg | Experimental | Cohort 4: Cirmtuzumab 2.0 mg/kg for two 14-day cycles, followed by cirmtuzumab 4.0 mg/kg for two 14-day cycles via IV infusion Receives: Drug: cirmtuzumab |
| Cirmtuzumab 8 mg/kg | Experimental | Cohort 5: Cirmtuzumab 8 mg/kg for four 14-day cycles via IV infusion Receives: Drug: cirmtuzumab |
| Cirmtuzumab 16 mg/kg | Experimental | Cohort 6: Cirmtuzumab 16 mg/kg for four 14-day cycles (or maximum 2000 mg) via IV infusion Receives: Drug: cirmtuzumab |
| Cirmtuzumab 20 mg/kg | Experimental | Cohort 7: Cirmtuzumab 20 mg/kg for four 14-day cycles (or maximum 2000 mg) Receives: Drug: cirmtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) or Biologically Active Dose of Cirmtuzumab
The MTD is defined as the highest dose studied at which no more than one in six patients experience a dose-limiting toxicity (DLT) during the DLT observation period. The biologically active dose will be determined at a dose below or equal to the MTD upon review of the the study data; the final determination will also consider any cumulative or delayed toxicity.
Measured: 1 year
Rate of Dose Limiting Toxicities (DLTs)
The occurrence of any of the following adverse events considered to be possibly, probably, or definitely related to cirmtuzumab within the DLT observation period (56 days from the first infusion for cohorts with intrapatient dose escalation, and 28 days of the start investigational treatment for cohorts without intrapatient dose escalation):
- Grade 3 or greater non-hematologic toxicity with the exception of Grade 3 infusion reaction.
- Grade 4 neutropenia lasting more than 5 days despite appropriate medical management.
- Grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding or any requirement for platelets transfusion.
- Grade 3 or greater febrile neutropenia (temperature ≥ 38.5ºC).
- Grade 4 anemia unexplained by underlying disease.
- Any AE requiring a dose delay of greater than 14 days.
- Patients with baseline cytopenias or starting blood counts in the grade 2 range are evaluable for hematologic DLT.
Measured: The DLT observation period is 56 days from the start of the first infusion for the intra-patient dosing cohorts and 28 days after the start of the first infusion for subsequent dosing cohorts
Secondary outcomes (3)
Safety and Tolerability of UC-961 by Ongoing Evaluation of AEs.
Treatment emergent adverse events (description, timing, CTCAE grade, severity, seriousness, and relatedness)
Measured: From the start of investigational treatment to completion of follow-up, an average of 33 weeks
Clinical Activity Determined by the International Working Group in CLL (iwCLL) Criteria
Clinical response [stable disease (SD) or progressive disease (PD)] defined by iwCLL criteria including clinical, hematological, and bone marrow features for a period of at least 2 months from completion of therapy
Measured: From baseline visit to response assessment visit at 56 days after final cirmtuzumab infusion, an average of 52 days
Progression Free Survival as Determined by iwCLL Criteria
The duration of time from the start of study treatment until objective tumor progression or death
Measured: From start of treatment until objective tumor progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study start8 Aug 2014
- Primary completion10 Oct 2017
- Study completion1 May 2018
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 Chronic Lymphocytic LeukemiaStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Kipps
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Kipps, University of California, San Diego
- Investigators
- Catriona Jamieson, M.D., Ph.D., Principal investigator, University of California Medical CenterMichael Choi, M.D., Principal investigator, University of Calilfornia Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222688
- Sponsor's protocol ID
- #140141
- Status last verified
- Jul 2020
- First submitted
- 19 Aug 2014
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Choi MY, Widhopf GF 2nd, Ghia EM, Kidwell RL, Hasan MK, Yu J, Rassenti LZ, Chen L, Chen Y, Pittman E, Pu M, Messer K, Prussak CE, Castro JE, Jamieson C, Kipps TJ. Phase I Trial: Cirmtuzumab Inhibits ROR1 Signaling and Stemness Signatures in Patients with Chronic Lymphocytic Leukemia. Cell Stem Cell. 2018 Jun 1;22(6):951-959.e3. doi: 10.1016/j.stem.2018.05.018.
PubMed 29859176
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Determine the Safety and Tolerability of UC-961 (Cirmtuzumab), an Anti-ROR1 Monoclonal Antibody, for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Are Ineligible for Chemotherapy
- ClinicalTrials.gov ID
- NCT02222688
- Acronym / sponsor ID
- #140141
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- cancer, CLL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Thomas KippsUniversity, hospital or other
- Study start
- 8 Aug 2014 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Posted 13 Aug 2020
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 the study is to investigate the safety of the investigational agent, cirmtuzumab. Cirmtuzumab is a monoclonal antibody drug designed to attach to a protein, called ROR1, on the surface of chronic lymphocytic leukemia (CLL) cells to block cell growth and survival. ROR1 is rarely expressed on healthy cells so the idea is to preferentially get rid of the cancer cells. Although there is evidence in laboratory animals that cirmtuzumab can decrease the number of CLL cells, the investigators do not know if this will work in humans. This drug will be given to humans for the first time in this study. Therefore, the goal of this study is to see if cirmtuzumab is safe and tolerated in study participants.
Detailed description
This is a first in human, open-label single institution, Phase I dose escalation study of in patients with relapsed or refractory CLL. Treatment cycle (14 days) will consist of cirmtuzumab administered intravenously on a bi-weekly (every two weeks) schedule for a total of 4 doses. Eight dose cohorts (of 3 to 6 patients in size) plus an expansion cohort of 6 patients are planned. In the first 4 dose cohorts, there is intra-patient dose escalation to monitor for acute toxicities, such as tumor lysis syndrome.
A cycle may be repeated every 14 days if the patient has at least stable disease by clinical examination (or interim response assessment) and has again met hematologic, renal, and hepatic laboratory parameters as defined in the eligibility section, and is without ongoing Grade 3 non-hematologic or Grade 4 hematologic toxicities attributable to cirmtuzumab. The total duration of study drug administration is 4 cycles. Each cycle consists of clinical and laboratory evaluation on Day 1 and safety assessments on Days 3 and 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cirmtuzumab 0.015 - 0.03 mg/kg | Experimental | Drug: cirmtuzumabCohort 1: Cirmtuzumab 0.015 mg/kg for two 14-day cycles followed by cirmtuzumab 0.03 mg/kg for two 14-day cycles via intravenous (IV) infusion |
| Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg | Experimental | Drug: cirmtuzumabCohort 2: Cirmtuzumab 0.06 mg/kg for one 14-day cycle, followed by cirmtuzumab 0.12 mg/kg for one 14-day cycle, followed by 0.24 mg/kg for two 14-day cycles via IV infusion |
| Cirmtuzumab 0.5 - 1.0 mg/kg | Experimental | Drug: cirmtuzumabCohort 3: Cirmtuzumab 0.5 mg/kg for one 14-day cycle, followed by cirmtuzumab 1.0 mg/kg for three 14-day cycles via IV infusion |
| Cirmtuzumab 2.0 - 4.0 mg/kg | Experimental | Drug: cirmtuzumabCohort 4: Cirmtuzumab 2.0 mg/kg for two 14-day cycles, followed by cirmtuzumab 4.0 mg/kg for two 14-day cycles via IV infusion |
| Cirmtuzumab 8 mg/kg | Experimental | Drug: cirmtuzumabCohort 5: Cirmtuzumab 8 mg/kg for four 14-day cycles via IV infusion |
| Cirmtuzumab 16 mg/kg | Experimental | Drug: cirmtuzumabCohort 6: Cirmtuzumab 16 mg/kg for four 14-day cycles (or maximum 2000 mg) via IV infusion |
| Cirmtuzumab 20 mg/kg | Experimental | Drug: cirmtuzumabCohort 7: Cirmtuzumab 20 mg/kg for four 14-day cycles (or maximum 2000 mg) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Clinical and phenotypic verification of B cell CLL and measurable disease. Immunophenotyping of the leukemic cells must demonstrate a monoclonal B cell population with immunophenotype consistent with CLL.
- Relapsed or refractory disease, defined by failure to achieve a partial response within 6 months of initiation of therapy, or a 50% increase of baseline disease measurements after achieving a clinical response.
- Not amenable to approved therapies.
- Prior Therapy: Must have progressed after purine-analog or alkylator based therapy, or be considered inappropriate for chemo-immunotherapy due to one of the following:
- Has recovered from the toxic effects of prior therapy to their clinical baseline.
Key exclusion criteria (16 listed)
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
- Patients who are currently receiving another investigational agent are excluded.
- Patients who have had chemotherapy (e.g., purine analogues, alkylating agents), immunotherapy, radiation therapy, or participation in any investigational drug treatment within 4 weeks of initiation of UC-961 or at any time during the study.
- Patients who have had prior (within 8 weeks of initiation of UC-961) or concurrent antibody therapy directed against CLL (i.e., Rituxan® and Campath®).
- Current infection requiring parenteral antibiotics.
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 |
|---|---|---|
| cirmtuzumabAlso: UC-961 | Drug | Cirmtuzumab 0.015 - 0.03 mg/kg, Cirmtuzumab 0.06 - 0.12 - 0.24 mg/kg, Cirmtuzumab 0.5 - 1.0 mg/kg, Cirmtuzumab 16 mg/kg, Cirmtuzumab 2.0 - 4.0 mg/kg, Cirmtuzumab 20 mg/kg, Cirmtuzumab 8 mg/kg |
Primary outcome
Maximum Tolerated Dose (MTD) or Biologically Active Dose of Cirmtuzumab
Time frame: 1 year
The MTD is defined as the highest dose studied at which no more than one in six patients experience a dose-limiting toxicity (DLT) during the DLT observation period. The biologically active dose will be determined at a dose below or equal to the MTD upon review of the the study data; the final determination will also consider any cumulative or delayed toxicity.
Rate of Dose Limiting Toxicities (DLTs)
Time frame: The DLT observation period is 56 days from the start of the first infusion for the intra-patient dosing cohorts and 28 days after the start of the first infusion for subsequent dosing cohorts
The occurrence of any of the following adverse events considered to be possibly, probably, or definitely related to cirmtuzumab within the DLT observation period (56 days from the first infusion for cohorts with intrapatient dose escalation, and 28 days of the start investigational treatment for cohorts without intrapatient dose escalation): 1. Grade 3 or greater non-hematologic toxicity with the exception of Grade 3 infusion reaction. 2. Grade 4 neutropenia lasting more than 5 days despite appropriate medical management. 3. Grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding or any requirement for platelets transfusion. 4. Grade 3 or greater febrile neutropenia (temperature ≥ 38.5ºC). 5. Grade 4 anemia unexplained by underlying disease. 6. Any AE requiring a dose delay of greater than 14 days. 7. Patients with baseline cytopenias or starting blood counts in the grade 2 range are evaluable for hematologic DLT.
3 secondary outcomes
Safety and Tolerability of UC-961 by Ongoing Evaluation of AEs.
Time frame: From the start of investigational treatment to completion of follow-up, an average of 33 weeks
Clinical Activity Determined by the International Working Group in CLL (iwCLL) Criteria
Time frame: From baseline visit to response assessment visit at 56 days after final cirmtuzumab infusion, an average of 52 days
Progression Free Survival as Determined by iwCLL Criteria
Time frame: From start of treatment until objective tumor progression or death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29859176Choi MY, Widhopf GF 2nd, Ghia EM, Kidwell RL, Hasan MK, Yu J, Rassenti LZ, Chen L, Chen Y, Pittman E, Pu M, Messer K, Prussak CE, Castro JE, Jamieson C, Kipps TJ. Phase I Trial: Cirmtuzumab Inhibits ROR1 Signaling and Stemness Signatures in Patients with Chronic Lymphocytic Leukemia. Cell Stem Cell. 2018 Jun 1;22(6):951-959.e3. doi: 10.1016/j.stem.2018.05.018.
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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.
Catriona Jamieson, M.D., Ph.D. principal investigator
University of California Medical Center
Michael Choi, M.D. principal investigator
University of Calilfornia Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cirmtuzumab in people with Chronic Lymphocytic Leukemia, run by Thomas Kipps 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 27 inclusion and 16 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 13 Aug 2020. 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 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?
Yes. Results are posted in the registry (first posted 13 Aug 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) or Biologically Active Dose of Cirmtuzumab (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT02222688, 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 13 Aug 2020.