Trial record 1 of 1 for:    BREAST MEDI-573
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Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01446159
First received: September 12, 2011
Last updated: May 27, 2014
Last verified: May 2014

September 12, 2011
May 27, 2014
June 2011
October 2015   (final data collection date for primary outcome measure)
  • Phase Ib: Safety and tolerability of 2 dose levels of MEDI-573 combined with AI [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    The primary objective of the dose-evaluation phase is to evaluate the safety and tolerability of 3 dose levels of MEDI 573 in combination with an AI in subjects with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative MBC. Specific endpoints: number of subjects with AEs, SAEs, and DLTs.
  • Phase 2 (Randomization Phase): Progression-free survival [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    The primary objective of the randomization phase is to evaluate the progression-free survival (PFS) of subjects with HR+, HER2-negative MBC treated with MEDI-573 and an AI versus treatment with an AI alone.
  • Phase Ib: Safety and tolerability of 2 dose levels of MEDI-573 combined with AI [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    The primary objective of the dose-evaluation phase is to evaluate the safety and tolerability of 2 dose levels of MEDI 573 in combination with an AI in subjects with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative MBC.
  • Phase 2 (Randomization Phase): Progression-free survival [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    The primary objective of the randomization phase is to evaluate the progression-free survival (PFS) of subjects with HR+, HER2-negative MBC treated with MEDI-573 and an AI versus treatment with an AI alone.
Complete list of historical versions of study NCT01446159 on ClinicalTrials.gov Archive Site
  • safety and tolerability of MEDI-573 in combination with an AI [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
    To describe the safety and tolerability of MEDI-573 when used in combination with an AI. Specific endpoints: Number of subjects with AEs and SAEs.
  • anti-tumor activity of MEDI-573 when used in combination with an AI [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    To evaluate the anti-tumor activity of MEDI-573 when used in combination with an AI versus treatment with an AI alone. Specific endpoints: Objective response rate, time to response, duration of response, time to progression, and change in tumor size.
  • overall survival (OS) [ Time Frame: 36+ months ] [ Designated as safety issue: No ]
    To evaluate overall survival (OS) in subjects treated with MEDI-573 when used in combination with an AI versus treatment with an AI alone.
  • pharmacokinetics (PK) of MEDI-573 [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    To describe the pharmacokinetics (PK) of MEDI-573 when used in combination with an AI. Specific endpoints: AUC, Cmax, systemic clearance, and half-life.
  • Pharmacodynamics of MEDI-573 [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    To evaluate the pharmacodynamics of MEDI-573 when used in combination with an AI on circulating levels of insulin-like growth factor I (IGF-I) and insulin-like growth factor II (IGF-II)
  • Immunogenicity of MEDI-573 [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    To evaluate the immunogenicity (IM) of MEDI-573 when used in combination with an AI. Specific endpoints: Number of patients who develop detectable anti-MEDI-573 antibodies.
  • safety and tolerability of MEDI-573 in combination with an AI [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
    To describe the safety and tolerability of MEDI-573 when used in combination with an AI
  • anti-tumor activity of MEDI-573 when used in combination with an AI [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    To evaluate the anti-tumor activity of MEDI-573 when used in combination with an AI versus treatment with an AI alone
  • overall survival (OS) [ Time Frame: 36+ months ] [ Designated as safety issue: No ]
    To evaluate overall survival (OS) in subjects treated with MEDI-573 when used in combination with an AI versus treatment with an AI alone
  • pharmacokinetics (PK) of MEDI-573 [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    To describe the pharmacokinetics (PK) of MEDI-573 when used in combination with an AI
  • Pharmacodynamics of MEDI-573 [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    To determine the pharmacodynamics of MEDI-573 when used in combination with an AI on circulating levels of insulin-like growth factor I (IGF-I) and insulin-like growth factor II (IGF-II)
  • Immunogenicity of MEDI-573 [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    To determine the immunogenicity (IM) of MEDI-573 when used in combination with an AI
Not Provided
Not Provided
 
Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)

This is a Phase 1b/2, multicenter, open-label study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an AI in adult subjects with HR+, HER2-negative MBC. This study has 2 phases: a dose-evaluation phase (Phase 1b) and a randomization phase (Phase 2).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer
  • Drug: MEDI-573
    MEDI-573
  • Drug: Aromatase Inhibitor
    aromatase inhibitor
  • Experimental: Dose evaluation Cohort A
    MEDI-573 in combination with aromatase Inhibitor
    Interventions:
    • Drug: MEDI-573
    • Drug: Aromatase Inhibitor
  • Experimental: Dose evaluation Cohort B
    MEDI-573 in combination with aromatase Inhibitor
    Interventions:
    • Drug: MEDI-573
    • Drug: Aromatase Inhibitor
  • Experimental: Dose Evaluation Cohort C
    MEDI-573 in combination with aromatase Inhibitor
    Interventions:
    • Drug: MEDI-573
    • Drug: Aromatase Inhibitor
  • Experimental: Randomized Arm 1
    MEDI-573 in combination with aromatase Inhibitor
    Interventions:
    • Drug: MEDI-573
    • Drug: Aromatase Inhibitor
  • Active Comparator: Randomized Arm 2
    aromatase inhibitor alone
    Intervention: Drug: Aromatase Inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
234
October 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy
  • Tumors are positive for ER, PgR, or both
  • Tumors must be negative for HER2 (by FISH, CISH or IHC)
  • Female gender and age ≥ 18 years at time of study entry
  • Postmenopausal
  • Karnofsky Performance Status ≥ 70
  • Life expectancy of ≥ 6 months

Exclusion Criteria:

  • Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:

    • Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573
    • Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
  • Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)
  • Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573
  • Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis
  • Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ≤ Grade 1 at the time of starting study treatment
  • Previous treatment with agents that target the IGF receptor
  • History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI
  • History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Poorly controlled diabetes mellitus
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bahamas,   Belgium,   Canada,   France,   Germany,   Hungary,   Israel,   Poland,   Spain,   United Kingdom
 
NCT01446159
CD-ON-MEDI-573-1030
No
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Jennifer McDevitt, PharmD, Ph.D. MedImmune LLC
MedImmune LLC
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP