CancerPhase 1NCT00816361
A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors
A Phase 1 study testing MEDI-573 in people with Cancer, run by MedImmune LLC at 6 sites in United States.
Trial summary
Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer
- What is being tested?
- MEDI-573
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Mar 2009to 11 Sep 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced solid tumor for which no curative or standard therapies exist.
- Karnofsky Performance Status ≥60.
- Adequate hematological function.
- Adequate organ function.
- Women of non-child-bearing potential (defined as being >1 year post-menopausal) or using effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the investigational product may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from the time the informed consent is signed through 30 days after the last dose of MEDI-573. Male subjects with partners of child-bearing potential must be surgically sterile or use contraceptive method as described above from the time of the initiation of MEDI-573 through 30 days after the last dose of MEDI-573.
Who cannot join
- No prior treatment within 4 weeks of study drug administration.
- No concurrent therapy for treatment of cancer.
- No uncontrolled diabetes.
- New York Heart Association Grade ≥ 2 congestive heart failure.
- History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry.
- Documented brain metastasis.
- Pregnancy or lactation or plans to become pregnant while on study.
- Clinically significant abnormality on ECG.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Boston, Massachusetts, 02115
Research Site
Detroit, Michigan, 48201
Research Site
Jacksonville, Florida, 32224
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
Rochester, Minnesota, 55905
Research Site
Scottsdale, Arizona, 85259
About this study
Official title: A Phase 1, Multicenter, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists
Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.
- Conditions
- Cancer
- Being tested
- MEDI-573
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-573Drug
Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| MEDI-573 0.5 mg/Kg QWk Dose Escalation | Experimental | Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. Receives: Drug: MEDI-573 |
| MEDI-573 1.5 mg/Kg QWk Dose Escalation | Experimental | Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. Receives: Drug: MEDI-573 |
| MEDI-573 5 mg/Kg QWk Dose Escalation | Experimental | Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. Receives: Drug: MEDI-573 |
| MEDI-573 10 mg/Kg QWk Dose Escalation | Experimental | Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. Receives: Drug: MEDI-573 |
| MEDI-573 15 mg/Kg QWk Dose Escalation | Experimental | Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. Receives: Drug: MEDI-573 |
| MEDI-573 30 mg/Kg Q3Wk Dose Escalation | Experimental | Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. Receives: Drug: MEDI-573 |
| MEDI-573 45 mg/Kg Q3Wk Dose Escalation | Experimental | Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. Receives: Drug: MEDI-573 |
| MEDI-573 5 mg/Kg QWk Dose Expansion | Experimental | Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. Receives: Drug: MEDI-573 |
| MEDI-573 15 mg/Kg QWk Dose Expansion | Experimental | Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. Receives: Drug: MEDI-573 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
AEs were any unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of MEDI-573, whether or not considered related to MEDI-573. A SAE was any AE that resulted in: death; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; was life-threatening; was a congenital anomaly/birth defect in the offspring of a study participant; or was an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above. TEAEs were defined as AEs present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, up to 30 days after the last dose.
Measured: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
An abnormal laboratory finding that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
Measured: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Vital signs and physical findings included parameters such as heart rate, blood pressure, temperature, and respiratory rate. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573 or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
Measured: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Maximum Tolerated Dose (MTD) of MEDI-573
The MTD was defined as the highest dose that can be safely administered to participants and was determined by the number of participants in each cohort with a dose-limiting toxicity (DLT). The number and proportion of participants in each dose cohort and the number of participants with a DLT was presented using the total number of participants in the MTD Evaluable Population as the denominator. 2 participants from Cohorts 0.5 and 5 mg/kg QWk (1 in each cohort) did not complete the DLT period and therefore not evaluable for MTD.
Measured: Cycle 1 Day 1 through Cycle 1 Day 21
Number of Participants With Dose-Limiting Toxicities (DLTs)
A DLT was defined as any grade greater than or equal to (>=) 3 treatment-related non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: Grade less than (<) 4 serum-high glucose (fasting) with duration of < 24 hours; Grade 3 fever (in the absence of neutropenia) defined as > 40.0 degree centigrade (°C) [greater than (>) 104.0°F] that resolved to normal or baseline within 24 hours of treatment and was not considered an SAE; or Grade 3 rigors/chills that responded to optimal therapy; any Grade >= 3 treatment-related hematologic toxicity that occurred during the DLT assessment period.
Measured: Cycle 1 Day 1 through Cycle 1 Day 21
Optimal Biologically Effective Dose (OBED) of MEDI-573
The OBED was defined as the dose at which all circulating insulin-like growth factor (IGF)-1 and IGF-2 ligand was sequestered by MEDI-573.
Measured: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Secondary outcomes (14)
Maximum Observed Serum Concentration (Cmax) After the First Dose
The Cmax was the maximum observed serum concentration of MEDI-573.
Measured: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Time to Reach Maximum Observed Concentration (Tmax) After the First Dose
The tmax was defined as actual sampling time to reach the maximum observed serum concentration of MEDI-573.
Measured: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Trough Serum Concentration (Ctrough) After the First Dose
The Ctrough was the lowest serum concentration of MEDI-573 within a dosing interval.
Measured: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Dose Normalized Cmax (Cmax/Dose) After the First Dose
The Cmax/dose was the dose-normalized maximum serum concentration of MEDI-573.
Measured: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Area Under the Serum Concentration-time Curve Over the First Dosing Interval (AUCτ)
Area under the serum concentration-time curve over the first dosing interval.
Measured: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Dose-normalized Area Under the Serum Concentration Time Curve Over the First Dosing Interval (AUCτ/Dose)
The AUCtau/dose was a measure of dose-normalized area under the serum concentration-time curve over the first dosing interval.
Measured: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI-573
Two methods were used to assess the immunogenicity data: an ECL-based method and measurement of neutralizing ADA. The titer was calculated by multiplying the minimum assay dilution factor by the reciprocal of the highest dilution factor which yielded an ECL multiple equal to or greater than the screening assay cut-point factor.
Measured: Pre-infusion on Day 1 of each cycle, end of treatment, and 90 days after last dose MEDI-573 (up to 3.5 years)
Objective Response Rate (ORR)
The ORR was defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) according to the RECIST criteria The CR was defined as disappearance of all target and nontarget lesions and no new lesions; and PR was definded as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline [screening]) and no new lesions.
Measured: From study entry through the end of the study, up to 3.5 years
Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression or death due to any cause, whichever occurred first.
Measured: From study entry through the end of the study, up to 3.5 years
Time to Progression
Time to disease progression (TTP) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression.
Measured: From study entry through the end of the study, up to 3.5 years
Overall Survival
Overall survival (OS) was defined as the time from the start of treatment with MEDI-573 until death.
Measured: From study entry through the end of the study, up to 3.5 years
Time to Response (TTR)
Time to response was defined as the duration from the start of treatment with MEDI-573 to the first documentation of objective response (confirmed CR or PR) and was only assessed in participants who had achieved objective response.
Measured: From study entry through the end of the study, up to 3.5 years
Duration of Response
Duration of response was defined as the duration from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression.
Measured: From study entry through the end of the study, up to 3.5 years
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
The suppression profiles of both IGF-1 and IGF-2 post administration of MEDI-573 in relation to time course of antibody concentrations in serum were evaluated during treatment.
Measured: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study start9 Mar 2009
- Primary completion11 Sep 2012
- Study completion11 Sep 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 CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Perez, MD, MSc, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816361
- Sponsor's protocol ID
- MI-CP184
- Status last verified
- Oct 2018
- First submitted
- 23 Dec 2008
- Last updated
- 4 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists
- ClinicalTrials.gov ID
- NCT00816361
- Acronym / sponsor ID
- MI-CP184
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2009 (actual)
- Primary completion
- 11 Sep 2012 (actual)
- Study completion
- 11 Sep 2012 (actual)
- First posted
- 1 Jan 2009 (estimated)
- Results
- Posted 4 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| MEDI-573 0.5 mg/Kg QWk Dose Escalation | Experimental | Drug: MEDI-573Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. |
| MEDI-573 1.5 mg/Kg QWk Dose Escalation | Experimental | Drug: MEDI-573Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. |
| MEDI-573 5 mg/Kg QWk Dose Escalation | Experimental | Drug: MEDI-573Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. |
| MEDI-573 10 mg/Kg QWk Dose Escalation | Experimental | Drug: MEDI-573Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. |
| MEDI-573 15 mg/Kg QWk Dose Escalation | Experimental | Drug: MEDI-573Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. |
| MEDI-573 30 mg/Kg Q3Wk Dose Escalation | Experimental | Drug: MEDI-573Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. |
| MEDI-573 45 mg/Kg Q3Wk Dose Escalation | Experimental | Drug: MEDI-573Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. |
| MEDI-573 5 mg/Kg QWk Dose Expansion | Experimental | Drug: MEDI-573Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. |
| MEDI-573 15 mg/Kg QWk Dose Expansion | Experimental | Drug: MEDI-573Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed advanced solid tumor for which no curative or standard therapies exist.
- Karnofsky Performance Status ≥60.
- Adequate hematological function.
- Adequate organ function.
- Women of non-child-bearing potential (defined as being >1 year post-menopausal) or using effective contraception, e.g., use of oral contraceptives with an additional barrier method (since the investigational product may impair the effectiveness of oral contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from the time the informed consent is signed through 30 days after the last dose of MEDI-573. Male subjects with partners of child-bearing potential must be surgically sterile or use contraceptive method as described above from the time of the initiation of MEDI-573 through 30 days after the last dose of MEDI-573.
Key exclusion criteria (8 listed)
- No prior treatment within 4 weeks of study drug administration.
- No concurrent therapy for treatment of cancer.
- No uncontrolled diabetes.
- New York Heart Association Grade ≥ 2 congestive heart failure.
- History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry.
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 |
|---|---|---|
| MEDI-573Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. | Drug | MEDI-573 0.5 mg/Kg QWk Dose Escalation, MEDI-573 1.5 mg/Kg QWk Dose Escalation, MEDI-573 10 mg/Kg QWk Dose Escalation, MEDI-573 15 mg/Kg QWk Dose Escalation, MEDI-573 15 mg/Kg QWk Dose Expansion, MEDI-573 30 mg/Kg Q3Wk Dose Escalation, MEDI-573 45 mg/Kg Q3Wk Dose Escalation, MEDI-573 5 mg/Kg QWk Dose Escalation, MEDI-573 5 mg/Kg QWk Dose Expansion |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Time frame: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
AEs were any unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of MEDI-573, whether or not considered related to MEDI-573. A SAE was any AE that resulted in: death; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; was life-threatening; was a congenital anomaly/birth defect in the offspring of a study participant; or was an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above. TEAEs were defined as AEs present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, up to 30 days after the last dose.
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Time frame: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
An abnormal laboratory finding that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Time frame: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Vital signs and physical findings included parameters such as heart rate, blood pressure, temperature, and respiratory rate. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573 or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
Maximum Tolerated Dose (MTD) of MEDI-573
Time frame: Cycle 1 Day 1 through Cycle 1 Day 21
The MTD was defined as the highest dose that can be safely administered to participants and was determined by the number of participants in each cohort with a dose-limiting toxicity (DLT). The number and proportion of participants in each dose cohort and the number of participants with a DLT was presented using the total number of participants in the MTD Evaluable Population as the denominator. 2 participants from Cohorts 0.5 and 5 mg/kg QWk (1 in each cohort) did not complete the DLT period and therefore not evaluable for MTD.
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 Day 1 through Cycle 1 Day 21
A DLT was defined as any grade greater than or equal to (>=) 3 treatment-related non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: Grade less than (<) 4 serum-high glucose (fasting) with duration of < 24 hours; Grade 3 fever (in the absence of neutropenia) defined as > 40.0 degree centigrade (°C) [greater than (>) 104.0°F] that resolved to normal or baseline within 24 hours of treatment and was not considered an SAE; or Grade 3 rigors/chills that responded to optimal therapy; any Grade >= 3 treatment-related hematologic toxicity that occurred during the DLT assessment period.
Optimal Biologically Effective Dose (OBED) of MEDI-573
Time frame: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
The OBED was defined as the dose at which all circulating insulin-like growth factor (IGF)-1 and IGF-2 ligand was sequestered by MEDI-573.
14 secondary outcomes
Maximum Observed Serum Concentration (Cmax) After the First Dose
Time frame: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Time to Reach Maximum Observed Concentration (Tmax) After the First Dose
Time frame: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Trough Serum Concentration (Ctrough) After the First Dose
Time frame: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Dose Normalized Cmax (Cmax/Dose) After the First Dose
Time frame: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Area Under the Serum Concentration-time Curve Over the First Dosing Interval (AUCτ)
Time frame: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Dose-normalized Area Under the Serum Concentration Time Curve Over the First Dosing Interval (AUCτ/Dose)
Time frame: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI-573
Time frame: Pre-infusion on Day 1 of each cycle, end of treatment, and 90 days after last dose MEDI-573 (up to 3.5 years)
Objective Response Rate (ORR)
Time frame: From study entry through the end of the study, up to 3.5 years
Progression-free Survival (PFS)
Time frame: From study entry through the end of the study, up to 3.5 years
Time to Progression
Time frame: From study entry through the end of the study, up to 3.5 years
Overall Survival
Time frame: From study entry through the end of the study, up to 3.5 years
Time to Response (TTR)
Time frame: From study entry through the end of the study, up to 3.5 years
Duration of Response
Time frame: From study entry through the end of the study, up to 3.5 years
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
Time frame: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MEDI-573\_CP-184\_Protocol\_Redacted\_16Jul14Link provided by the sponsor.
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Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
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.
Susan Perez, MD, MSc study director
MedImmune LLC
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 MEDI-573 in people with Cancer, run by MedImmune LLC at 6 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 5 inclusion and 8 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 4 Mar 2019. 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 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 4 Mar 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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) (time frame: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years). The study lists 6 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 4 Mar 2019.