Solid TumorsPhase 1NCT01222624
PankoMab-GEX™: Phase 1 Dose Escalation Study
A Phase 1 study testing PankoMab-GEX™ in people with Solid Tumors, run by Glycotope GmbH at 4 sites in 3 countries.
Trial summary
Prospective, open label, dose escalating, multicenter, phase I study measuring the safety, tolerability, and pharmacokinetics of PankoMab-GEX™ after intravenous administration in patients with locally advanced or metastatic solid cancers refractory to standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- PankoMab-GEX™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Nov 2009to May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female and age ≥ 18 yrs
- Histologically-confirmed TA-MUC1 positive measurable or non-measurable solid tumors according to RECIST criteria who failed standard therapy and for whom no further standard therapy is available (TA-MUC1 positivity assessed by PankoMab-GEX™ staining in immunohistology of the tumor).
- Failure of standard therapy or non-availability of standard therapy
- Patients must have received at least 1 standard chemotherapy during the course of the tumor disease
- All therapies must be completed 6 weeks (therapeutic monoclonal antibodies) or 4 weeks (all other anti-cancer agents) before start of study treatment and patients must have recovered from all prior therapy toxicities to at least CTCAE grade 1
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1 and estimated life expectancy of > 3 months
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- Adequate organ function as assessed by the following laboratory parameters within 14 days prior to study drug application:
- Bone marrow function: hemoglobin ≥ 100 g/L; white blood cell count (WBC) ≥ 3.0 x 10^9/L; absolute neutrophil count (ANC) ≥ 1.5x 10^9/L; platelet count ≥ 100 x 10^9/L
- Hepatic: aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 times upper limit of normal (ULN) (≤ 5 x ULN if hepatic metastases present); bilirubin ≤ 1.5 x ULN; alkaline phosphatase ≤ 5.0 times upper limit of normal (ULN)
- Renal: Calculated creatinine clearance > 80 ml/min using the Modification of Diet in Renal Disease (MDRD) formula according to Levey 2005: Glomerular filtration rate (GFR) (ml/min/1.73 m²) = 186 x (serum creatinine /0,95)^-1.154 x (age)^-0.203 x (0.742 females) x (1.21 in black patients)
- Patients of both genders with procreative potential must use effective contraception while enrolled in the study and for at least 6 weeks after the last study drug infusion
- Written informed consent must be obtained prior to conducting any study-specific procedures
Who cannot join
- Antibody-based immunotherapy within 6 weeks and chemotherapy, radiation or other anti-cancer therapies within 4 weeks prior to study enrolment
- Any investigational agents at the study enrolment
- Concurrent anti-tumor therapy or concurrent immunotherapy
- Concurrent systemic steroids except topical (inhaled, topical, nasal), replacement therapy for the last 28 days. Steroids at low and stable dose (up to 20 mg prednisone) given for chronic disease are also permitted
- History of allergic reactions to previous antibody therapy
- Major surgery within 4 weeks prior entering the study and/or incomplete recovery from surgery or planned major surgery
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- Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy such as sarcoidosis, lupus erythematosus, rheumatoid arthritis, glomerulonephritis or systemic vasculitis (except autoimmune thyroiditis with only thyroid hormone replacement and stable disease >1 year)
- Primary or secondary immune deficiency
- Clinically active infections > CTCAE grade 2
- Prior allergic reaction to a monoclonal antibody (e.g. Trastuzumab, Cetuximab or Bevacizumab).
- Active hepatitis B or C; human immunodeficiency virus (HIV) seropositivity
- Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥3 years will be allowed to enter the study.
- Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, chronic symptomatic respiratory disease.
- Brain metastasis or leptomeningeal involvement
- Symptomatic congestive heart failure (New York Heart Association [NYHA] 3 or 4); unstable angina pectoris within 6 months prior to enrollment; significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year or left ventricular ejection fraction (LVEF) below the institutional range of normal on a baseline multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
- History of seizures, encephalitis or multiple sclerosis
- History of deep vein thrombosis and/or thromboembolic events within the past 6 months before entering the study and/or requiring anticoagulation therapy
- Evidence or history of bleeding diathesis or coagulopathy
- Active drug abuse or chronic alcoholism
- Pregnancy or breastfeeding
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Italy2 sites
Glycotope Investigational Site
Milan, 20132
Glycotope Investigational Site
Milan, 20133
About this study
Official title: Phase I Dose Escalation Study Evaluating the Safety and Tolerability of PankoMab-GEX™ in Patients With Advanced, TA-MUC1 Positive Solid Malignancies Who Are Not Longer Eligible for Standard Therapy
Prospective, open label, dose escalating, multicenter, phase I study measuring the safety, tolerability, and pharmacokinetics of PankoMab-GEX™ after intravenous administration in patients with locally advanced or metastatic solid cancers refractory to standard treatment. The effect of PankoMab-GEX™ on the development of antibodies and tumor response was also evaluated.
Read the detailed description
Male or female patients of age 18 years or older with a histologically-confirmed, tumor-associated mucin 1 (TA-MUC1) positive, measurable or non-measurable solid tumor who had failed standard therapy and for whom no standard therapy was available.
Open-label, non-randomized, inter-patient dose escalation, multi-center study in a 3 + 3 design.
Patients received PankoMab-GEX™ treatment until disease progression or until the treatment was no longer tolerated.
- Conditions
- Solid Tumors
- Being tested
- PankoMab-GEX™
- Keywords
- advanced solid malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PankoMab-GEX™Drug
Also called gatipotuzumab
| Study group | Role | What they receive |
|---|---|---|
| PankoMab-GEX™, 3-weekly | Experimental | application, q3w Receives: Drug: PankoMab-GEX™ |
| PankoMab-GEX™, 2-weekly | Experimental | application q2w Receives: Drug: PankoMab-GEX™ |
| PankoMab-GEX™, weekly | Experimental | application q1w Receives: Drug: PankoMab-GEX™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], Version 3.0
Adverse events coded using Medical Dictionary for Regulatory Activities (MedDRA) version 13.1
Measured: Until 28±2 days following the last infusion
Incidence of Treatment-Emergent abnormal clinical laboratory parameters assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], Version 3.0
Analyzed in local clinical laboratories
Measured: Until 28±2 days following the last infusion
Changes in corrected QT interval (QTc) duration
based on Electrocardiograms (ECG)
Measured: Until 28±2 days following the last infusion
Changes of left ventricular ejection fraction (LVEF)
based on Multiple Gated Acquisition (MUGA) scan or Echocardiogram (ECHO)
Measured: Until 28±2 days following the last infusion
Eastern Cooperative Oncology Group (ECOG) Performance Status
The ECOG Scale of Performance Status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The scale comprises six grades:
0 Fully active, able to carry on all pre-disease performance without restriction
- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
- Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
- Dead
Measured: Until 28±2 days following the last infusion
Secondary outcomes (11)
Pharmacokinetics (PK): Peak Plasma Concentration (Cmax)
PK of PankoMab-GEX™ in patients after single and multiple dose applications
Measured: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
Pharmacokinetics (PK): Minimum Drug Concentration (Cmin)
PK of PankoMab-GEX™ in patients after single and multiple dose applications
Measured: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
Pharmacokinetics (PK):Time to reach Cmax (tmax)
PK of PankoMab-GEX™ in patients after single and multiple dose applications
Measured: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
Pharmacokinetics (PK): Area under the curve (AUC)
PK of PankoMab-GEX™ in patients after single and multiple dose applications
Measured: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
Pharmacokinetics (PK): Apparent terminal serum half-life (t1/2)
PK of PankoMab-GEX™ in patients after single and multiple dose applications
Measured: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
To evaluate any immunogenicity
Anti-drug antibodies (ADAs)
Measured: Anti-drug antibodies (ADAs) were to be measured before the first infusion of study medication, prior to the second infusion, 4 weeks and 8 weeks after the last study medication administration.
Tumor response: Best observed response
Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor response: Objective response rate (ORR)
Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor response: Clinical benefit rate (CBR)
Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor response: Duration of response
Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor response: Duration of stable disease
Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycotope GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glycotope GmbH, Study director, Glycotope GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222624
- Sponsor's protocol ID
- GEXMab25101
- Status last verified
- May 2021
- First submitted
- 15 Oct 2010
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fiedler W, DeDosso S, Cresta S, Weidmann J, Tessari A, Salzberg M, Dietrich B, Baumeister H, Goletz S, Gianni L, Sessa C. A phase I study of PankoMab-GEX, a humanised glyco-optimised monoclonal antibody to a novel tumour-specific MUC1 glycopeptide epitope in patients with advanced carcinomas. Eur J Cancer. 2016 Aug;63:55-63. doi: 10.1016/j.ejca.2016.05.003. Epub 2016 Jun 7.
PubMed 27285281
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Study Evaluating the Safety and Tolerability of PankoMab-GEX™ in Patients With Advanced, TA-MUC1 Positive Solid Malignancies Who Are Not Longer Eligible for Standard Therapy
- ClinicalTrials.gov ID
- NCT01222624
- Acronym / sponsor ID
- GEXMab25101
- Conditions
- Solid Tumors
- Keywords
- advanced solid malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Glycotope GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 Oct 2010 (estimated)
- 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.
Prospective, open label, dose escalating, multicenter, phase I study measuring the safety, tolerability, and pharmacokinetics of PankoMab-GEX™ after intravenous administration in patients with locally advanced or metastatic solid cancers refractory to standard treatment. The effect of PankoMab-GEX™ on the development of antibodies and tumor response was also evaluated.
Detailed description
Male or female patients of age 18 years or older with a histologically-confirmed, tumor-associated mucin 1 (TA-MUC1) positive, measurable or non-measurable solid tumor who had failed standard therapy and for whom no standard therapy was available.
Open-label, non-randomized, inter-patient dose escalation, multi-center study in a 3 + 3 design.
Patients received PankoMab-GEX™ treatment until disease progression or until the treatment was no longer tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PankoMab-GEX™, 3-weekly | Experimental | Drug: PankoMab-GEX™application, q3w |
| PankoMab-GEX™, 2-weekly | Experimental | Drug: PankoMab-GEX™application q2w |
| PankoMab-GEX™, weekly | Experimental | Drug: PankoMab-GEX™application q1w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female and age ≥ 18 yrs
- Histologically-confirmed TA-MUC1 positive measurable or non-measurable solid tumors according to RECIST criteria who failed standard therapy and for whom no further standard therapy is available (TA-MUC1 positivity assessed by PankoMab-GEX™ staining in immunohistology of the tumor).
- Failure of standard therapy or non-availability of standard therapy
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1 and estimated life expectancy of > 3 months
- Adequate organ function as assessed by the following laboratory parameters within 14 days prior to study drug application:
Key exclusion criteria (20 listed)
- Antibody-based immunotherapy within 6 weeks and chemotherapy, radiation or other anti-cancer therapies within 4 weeks prior to study enrolment
- Any investigational agents at the study enrolment
- Concurrent anti-tumor therapy or concurrent immunotherapy
- Concurrent systemic steroids except topical (inhaled, topical, nasal), replacement therapy for the last 28 days. Steroids at low and stable dose (up to 20 mg prednisone) given for chronic disease are also permitted
- History of allergic reactions to previous antibody therapy
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 |
|---|---|---|
| PankoMab-GEX™Also: gatipotuzumab | Drug | PankoMab-GEX™, 2-weekly, PankoMab-GEX™, 3-weekly, PankoMab-GEX™, weekly |
Primary outcome
Incidence of Treatment-Emergent Adverse Events assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], Version 3.0
Time frame: Until 28±2 days following the last infusion
Adverse events coded using Medical Dictionary for Regulatory Activities (MedDRA) version 13.1
Incidence of Treatment-Emergent abnormal clinical laboratory parameters assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], Version 3.0
Time frame: Until 28±2 days following the last infusion
Analyzed in local clinical laboratories
Changes in corrected QT interval (QTc) duration
Time frame: Until 28±2 days following the last infusion
based on Electrocardiograms (ECG)
Changes of left ventricular ejection fraction (LVEF)
Time frame: Until 28±2 days following the last infusion
based on Multiple Gated Acquisition (MUGA) scan or Echocardiogram (ECHO)
Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Until 28±2 days following the last infusion
The ECOG Scale of Performance Status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The scale comprises six grades: 0 Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead
11 secondary outcomes
Pharmacokinetics (PK): Peak Plasma Concentration (Cmax)
Time frame: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
Pharmacokinetics (PK): Minimum Drug Concentration (Cmin)
Time frame: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
Pharmacokinetics (PK):Time to reach Cmax (tmax)
Time frame: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
Pharmacokinetics (PK): Area under the curve (AUC)
Time frame: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
Pharmacokinetics (PK): Apparent terminal serum half-life (t1/2)
Time frame: Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks
To evaluate any immunogenicity
Time frame: Anti-drug antibodies (ADAs) were to be measured before the first infusion of study medication, prior to the second infusion, 4 weeks and 8 weeks after the last study medication administration.
Tumor response: Best observed response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor response: Objective response rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor response: Clinical benefit rate (CBR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor response: Duration of response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor response: Duration of stable disease
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Results publication: PubMed 27285281Fiedler W, DeDosso S, Cresta S, Weidmann J, Tessari A, Salzberg M, Dietrich B, Baumeister H, Goletz S, Gianni L, Sessa C. A phase I study of PankoMab-GEX, a humanised glyco-optimised monoclonal antibody to a novel tumour-specific MUC1 glycopeptide epitope in patients with advanced carcinomas. Eur J Cancer. 2016 Aug;63:55-63. doi: 10.1016/j.ejca.2016.05.003. Epub 2016 Jun 7.
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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.
Glycotope GmbH study director
Glycotope GmbH
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PankoMab-GEX™ in people with Solid Tumors, run by Glycotope GmbH at 4 sites in 3 countries.
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 12 inclusion and 20 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 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Germany, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Treatment-Emergent Adverse Events assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], Version 3.0 (time frame: Until 28±2 days following the last infusion). The study lists 5 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 NCT01222624, 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 20 May 2021.