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NCT01248949 · REGISTRY CONDITION SEARCH

A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2017-03-29

To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Maximum Tolerated Dose (MTD)

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

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outcome · POSTED

Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)

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outcome · POSTED

Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)

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outcome · POSTED

Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs)

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outcome · POSTED

Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs)

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outcome · POSTED

Maximum Observed Serum Concentration (Cmax) of MEDI3617

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outcome · POSTED

Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617

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outcome · POSTED

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617

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outcome · POSTED

Systemic Clearance (CL) of MEDI3617

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outcome · POSTED

Terminal Elimination Half Life (t1/2) of MEDI3617

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outcome · POSTED

Number of Participants With Positive Anti-Drug Antibody (ADA)

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Time to Response (TTR)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Time to Progression (TTP)

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Circulating Levels of Angiopoietin 2 (Ang2)

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outcome · POSTED

Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or another solid tumor type based on antitumoral activity (dose-expansion phase) that are not responsive to standard therapy or for which no standard therapy exists * Patients must be 18 years of age or older * Karnofsky Performance Status ≥ 70 * Toxicities from previous cancer therapies must have recovered to CTCAE Grade = or \< 2 * Adequate organ and marrow function * Using adequate contraceptive measures, be surgically sterile or post-menopausal Exclusion Criteria: * Concurrently enrolled in another clinical study, except for non-interventiona observational studies, or if in a follow up period from a previous study * Receipt of any investigational anticancer therapy within 30 days prior to the first dose of MEDI3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days prior to the first dose of MEDI3617 * Current or previous treatment with angiopoietin inhibitors, or inhibitors of Tie1 or Tie2 including, but not limited to, AMG386, CVX-060, XL880, and XL820 * Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment * Use of immunosuppressive medication or systemic steroids within 7 days prior to first dose of MEDI3617 * Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results * Known bleeding diathesis * Pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment * Therapeutic or palliative radiation therapy within 2 weeks prior to enrollment
healthy Volunteers
false
maximum Age
99 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants will receive MEDI3617 via intravenous (IV) infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
    intervention Names
    1. Drug: MEDI3617
    label
    MEDI3617 SINGLE AGENT TOTAL
    type
    EXPERIMENTAL
  2. description
    Participants will receive MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
    intervention Names
    1. Drug: MEDI3617
    2. Drug: Bevacizumab
    label
    MEDI3617 + BEVACIZUMAB Q3W ESCALATION
    type
    EXPERIMENTAL
  3. description
    Participants will receive MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
    intervention Names
    1. Drug: MEDI3617
    2. Drug: Bevacizumab
    label
    MEDI3617 + BEVACIZUMAB Q2W TOTAL
    type
    EXPERIMENTAL
  4. description
    Participants will receive MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
    intervention Names
    1. Drug: MEDI3617
    2. Drug: Paclitaxel
    label
    MEDI3617 + PACLITAXEL TOTAL
    type
    EXPERIMENTAL
  5. description
    Participants will receive MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
    intervention Names
    1. Drug: MEDI3617
    2. Drug: Paclitaxel
    3. Drug: Carboplatin
    label
    MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. MEDI3617 + BEVACIZUMAB Q2W TOTAL
    2. MEDI3617 + BEVACIZUMAB Q3W ESCALATION
    3. MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
    4. MEDI3617 + PACLITAXEL TOTAL
    5. MEDI3617 SINGLE AGENT TOTAL
    description
    Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.
    name
    MEDI3617
    type
    DRUG
  2. arm Group Labels
    1. MEDI3617 + BEVACIZUMAB Q2W TOTAL
    2. MEDI3617 + BEVACIZUMAB Q3W ESCALATION
    description
    Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.
    name
    Bevacizumab
    type
    DRUG
  3. arm Group Labels
    1. MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
    2. MEDI3617 + PACLITAXEL TOTAL
    description
    Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons.
    name
    Paclitaxel
    type
    DRUG
  4. arm Group Labels
    1. MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
    description
    Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons.
    name
    Carboplatin
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
162
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.
    measure
    Number of Participants With Dose Limiting Toxicities (DLTs)
    time Frame
    From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)
  2. description
    The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.
    measure
    Maximum Tolerated Dose (MTD)
    time Frame
    From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)
  3. description
    An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events occurring after administration of investigational product.
    measure
    Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
    time Frame
    From start of study drug administration up to 90 days after the last dose of MEDI3617
  4. description
    Laboratory evaluations were performed, including hematology and serum chemistry. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to laboratory abnormalities were recorded and reported.
    measure
    Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
    time Frame
    From start of study drug administration up to 90 days after the last dose of MEDI3617
  5. description
    Vital signs included parameters such as heart rate, blood pressure, temperature, weight and respiratory rate. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to vital signs abnormalities were recorded and reported.
    measure
    Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
    time Frame
    From start of study drug administration up to 90 days after the last dose of MEDI3617
  6. description
    An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to echocardiogram abnormalities were recorded and reported. The only AE reported was ejection fraction decreased in the MEDI3617 + Paclitaxel total group.
    measure
    Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs)
    time Frame
    From start of study drug administration up to 90 days after the last dose of MEDI3617
  7. description
    An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to electrocardiogram abnormalities were recorded and reported. The only AE reported was electrocardiogram QT prolonged in the MEDI3617 + Bevacizumab Q2W total group.
    measure
    Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs)
    time Frame
    From start of study drug administration up to 90 days after the last dose of MEDI3617
  8. description
    KPS scale: 100 is no evidence of disease; 90 is able to carry on normal activity, minor symptoms of disease; 80 is normal activity with effort, some symptoms of disease; 70 is cares for self; unable to do active work; 60 is requires occasional assistance, but is able to care for most of his needs; 50 is requires considerable assistance with frequent medical care; 40 is disabled, requires special care; 30 is severely disabled, hospitalization is indicated although death is not imminent; 20 is very sick, hospitalization necessary, active support treatment necessary; 10 is moribund, fatal processes progressing rapidly, 0 is dead.
    measure
    Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline
    time Frame
    From start of study drug administration up to 30 days after the last dose of MEDI3617
secondary Outcomes
  1. description
    Cmax is the maximum observed serum concentration of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.
    measure
    Maximum Observed Serum Concentration (Cmax) of MEDI3617
    time Frame
    Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
  2. description
    AUC0-last is the Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.
    measure
    Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
    time Frame
    Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
  3. description
    The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.
    measure
    Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
    time Frame
    Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
  4. description
    Systemic clearance describes the removal of drug from a volume of serum in a given unit of time (drug loss from the body). It is measured as milliliter per day (mL/day). Here, "n" is number of participants analyzed for this endpoint at a specific dose.
    measure
    Systemic Clearance (CL) of MEDI3617
    time Frame
    Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
  5. description
    The t1/2 is the time in days required for the concentration of the drug to reach half of its original value. Here, "n" is number of participants analyzed for this endpoint at a specific dose.
    measure
    Terminal Elimination Half Life (t1/2) of MEDI3617
    time Frame
    Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose
  6. description
    The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays.
    measure
    Number of Participants With Positive Anti-Drug Antibody (ADA)
    time Frame
    Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617
  7. description
    Objective response rate defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be "0" if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
    measure
    Objective Response Rate (ORR)
    time Frame
    Time from the first dose of investigational product until end of study
  8. description
    Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be "0" if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated using the Kaplan-Meier method.
    measure
    Time to Response (TTR)
    time Frame
    Time from the first dose of investigational product until end of study
  9. description
    Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method.
    measure
    Duration of Response (DOR)
    time Frame
    Time from the first dose of investigational product until end of study
  10. description
    Time to progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP was evaluated using the Kaplan-Meier method.
    measure
    Time to Progression (TTP)
    time Frame
    Time from the first dose of investigational product until end of study
  11. description
    PFS was measured from the start of treatment with MEDI3617 until the documentation of disease progression or death due to any cause, whichever occurred first. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had PFS censored on the first date of treatment with MEDI3617. PFS was evaluated using the Kaplan-Meier method.
    measure
    Progression-Free Survival (PFS)
    time Frame
    Time from the first dose of investigational product until end of study
  12. description
    Overall survival is defined as the time from the start of treatment with MEDI3617 until death. For the participants who were alive at the end of study or lost to follow-up, overall survival was censored on the last date when participants were known to be alive. Overall survival was evaluated using the Kaplan-Meier method.
    measure
    Overall Survival (OS)
    time Frame
    Time from the first dose of investigational product until death due to any cause
Full study description
brief Summary
To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice