Malignant MelanomaPhase 1NCT01137006
An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma
A Phase 1 study testing IMC-20D7S (Cohort 1A), IMC-20D7S (Cohort 2A) and IMC-20D7S (Cohort 3A) in people with Malignant Melanoma, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- IMC-20D7S (Cohort 1A), IMC-20D7S (Cohort 2A) and IMC-20D7S (Cohort 3A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy [for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
- Participant is ≥18 years of age
- Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
- At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
- Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
- Participant has adequate hematological function, hepatic function, and renal function
Who cannot join
- Participant has undergone major surgery [e.g., laparotomy, thoracotomy, removal of organ(s)] within 21 days prior to study entry
- Participant has elective or planned surgery to be conducted during the trial
- Participant has documented and/or symptomatic brain or leptomeningeal metastases
- Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
- Participant has an uncontrolled undercurrent illness
- Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
Show all 9Show fewer
- Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
- Participant is pregnant or lactating
- Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ImClone Investigational Site
Boston, Massachusetts, 02114
ImClone Investigational Site
New York, New York, 10021
About this study
Official title: An Open-Label, Dose-Escalation Phase 1/1b Study of the Anti-gp75 Monoclonal Antibody IMC-20D7S In Patients With Malignant Melanoma Who Have Progressed After or During at Least One Treatment With Standard Cytotoxic Treatment or/and Immunotherapy Therapy or For Whom Standard Therapy is Not Indicated
A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.
- Conditions
- Malignant Melanoma
- Being tested
- IMC-20D7S (Cohort 1A), IMC-20D7S (Cohort 2A), IMC-20D7S (Cohort 3A), IMC-20D7S (Cohort 4A), IMC-20D7S (Cohort 1B)
- Keywords
- Melanoma, Phase I, antibody, melanin, tyrosinase related protein 1, glycoprotein, 20D7S
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-20D7S (Cohort 1A)Biological
Also called LY3012215
5 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.
IMC-20D7S (Cohort 2A)Biological
Also called LY3012215
10 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A.
IMC-20D7S (Cohort 3A)Biological
Also called LY3012215
20 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A.
IMC-20D7S (Cohort 4A)Biological
Also called LY3012215
30 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
IMC-20D7S (Cohort 1B)Biological
Also called LY3012215
10 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B.
IMC-20D7S (Cohort 2B)Biological
Also called LY3012215
20 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B.
IMC-20D7S (Cohort 3B)Biological
Also called LY3012215
30 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| IMC-20D7S (1A-4A Cohorts) | Experimental | Escalating doses up to 30 milligrams per kilogram (mg/kg) administered intravenously (i.v.) every 2 weeks; includes Cohorts 1A, 2A, 3A, and 4A. Receives: Biological: IMC-20D7S (Cohort 1A); Biological: IMC-20D7S (Cohort 2A); Biological: IMC-20D7S (Cohort 3A); Biological: IMC-20D7S (Cohort 4A) |
| IMC-20D7S (1B-3B Cohorts) | Experimental | Escalating doses up to 30 mg/kg administered i.v. every 3 weeks; includes Cohorts 1B, 2B, and 3B. Receives: Biological: IMC-20D7S (Cohort 1B); Biological: IMC-20D7S (Cohort 2B); Biological: IMC-20D7S (Cohort 3B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of IMC-20D7S
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.
Measured: Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]
Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Measured: Baseline through 30 days post last dose (up to 31 weeks)
Secondary outcomes (9)
IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Measured: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Minimal Concentration (Cmin)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Measured: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Half-life (t½)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Measured: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Clearance (Cl)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Measured: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC)
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Measured: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Volume of Distribution (Vd) at Steady State
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Measured: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity)
Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses.
Measured: Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)
Progression-Free Survival (PFS)
PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3.
Measured: First dose to disease progression or death (up to 27 weeks)
Recommend Doses for Phase 2/3 Studies Based on MTD
It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b.
Measured: Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2012
- Study completionAug 2012
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 Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- E-mail: ClinicalTrials@ ImClone.com, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137006
- Sponsor's protocol ID
- 13945
- Other IDs
- CP22-0901, I4Z-IE-JDEA
- Status last verified
- Mar 2019
- First submitted
- 2 Jun 2010
- Last updated
- 17 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation Phase 1/1b Study of the Anti-gp75 Monoclonal Antibody IMC-20D7S In Patients With Malignant Melanoma Who Have Progressed After or During at Least One Treatment With Standard Cytotoxic Treatment or/and Immunotherapy Therapy or For Whom Standard Therapy is Not Indicated
- ClinicalTrials.gov ID
- NCT01137006
- Acronym / sponsor ID
- 13945
- Conditions
- Malignant Melanoma
- Keywords
- Melanoma, Phase I, antibody, melanin, tyrosinase related protein 1, glycoprotein, 20D7S
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMC-20D7S (1A-4A Cohorts) | Experimental | Biological: IMC-20D7S (Cohort 1A), Biological: IMC-20D7S (Cohort 2A), Biological: IMC-20D7S (Cohort 3A), Biological: IMC-20D7S (Cohort 4A)Escalating doses up to 30 milligrams per kilogram (mg/kg) administered intravenously (i.v.) every 2 weeks; includes Cohorts 1A, 2A, 3A, and 4A. |
| IMC-20D7S (1B-3B Cohorts) | Experimental | Biological: IMC-20D7S (Cohort 1B), Biological: IMC-20D7S (Cohort 2B), Biological: IMC-20D7S (Cohort 3B)Escalating doses up to 30 mg/kg administered i.v. every 3 weeks; includes Cohorts 1B, 2B, and 3B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy [for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
- Participant is ≥18 years of age
- Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
- At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
- Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
Key exclusion criteria (9 listed)
- Participant has undergone major surgery [e.g., laparotomy, thoracotomy, removal of organ(s)] within 21 days prior to study entry
- Participant has elective or planned surgery to be conducted during the trial
- Participant has documented and/or symptomatic brain or leptomeningeal metastases
- Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
- Participant has an uncontrolled undercurrent illness
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 |
|---|---|---|
| IMC-20D7S (Cohort 1A)Also: LY30122155 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A. | Biological | IMC-20D7S (1A-4A Cohorts) |
| IMC-20D7S (Cohort 2A)Also: LY301221510 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A. | Biological | IMC-20D7S (1A-4A Cohorts) |
| IMC-20D7S (Cohort 3A)Also: LY301221520 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A. | Biological | IMC-20D7S (1A-4A Cohorts) |
| IMC-20D7S (Cohort 4A)Also: LY301221530 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. | Biological | IMC-20D7S (1A-4A Cohorts) |
| IMC-20D7S (Cohort 1B)Also: LY301221510 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B. | Biological | IMC-20D7S (1B-3B Cohorts) |
| IMC-20D7S (Cohort 2B)Also: LY301221520 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B. | Biological | IMC-20D7S (1B-3B Cohorts) |
| IMC-20D7S (Cohort 3B)Also: LY301221530 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. | Biological | IMC-20D7S (1B-3B Cohorts) |
Primary outcome
Maximum Tolerated Dose (MTD) of IMC-20D7S
Time frame: Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.
Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death
Time frame: Baseline through 30 days post last dose (up to 31 weeks)
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
9 secondary outcomes
IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax)
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Minimal Concentration (Cmin)
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Half-life (t½)
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Clearance (Cl)
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC)
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
IMC-20D7S PK: Volume of Distribution (Vd) at Steady State
Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.
Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity)
Time frame: Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)
Progression-Free Survival (PFS)
Time frame: First dose to disease progression or death (up to 27 weeks)
Recommend Doses for Phase 2/3 Studies Based on MTD
Time frame: Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 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.
E-mail: ClinicalTrials@ ImClone.com study director
Eli Lilly and Company
2 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 IMC-20D7S (Cohort 1A), IMC-20D7S (Cohort 2A) and IMC-20D7S (Cohort 3A) in people with Malignant Melanoma, run by Eli Lilly and Company at 2 sites 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 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 17 Jun 2019). 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) of IMC-20D7S (time frame: Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.