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A Study of LY2510924 and Durvalumab in Participants With Solid Tumors

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02737072
First Posted: April 13, 2016
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company
April 8, 2016
April 13, 2016
November 15, 2017
September 2016
September 2017   (Final data collection date for primary outcome measure)
  • Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 Days) ]
  • Maximum Tolerated Dose (MTD) of LY2510924 [ Time Frame: Cycle 1 (28 Days) ]
Same as current
Complete list of historical versions of study NCT02737072 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Area Under the Concentration-Time Curve (AUC0-24) of LY2510924 when Co-Administered with Durvalumab [ Time Frame: Predose Cycle 1 Day 1 through 90 Day Post Treatment Follow Up (Estimated up to 9 Months) ]
  • Number of Participants with Anti-Durvalumab Antibodies when Administered in Combination with LY2510924 [ Time Frame: Predose Cycle 1 Day 1 through 90 Day Post Treatment Follow Up (Estimated up to 9 Months) ]
  • Overall Response Rate (ORR): Proportion of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease or Death (Estimated up to 18 months) ]
  • Disease Control Rate (DCR): Proportion of Participants who Exhibit Stable Disease (SD), CR or PR [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 18 months) ]
Same as current
Not Provided
Not Provided
 
A Study of LY2510924 and Durvalumab in Participants With Solid Tumors
A Phase 1a/1b Study of CXCR4 Peptide Antagonist (LY2510924) Administered in Combination With the Anti-PD-L1 Antibody, Durvalumab (MEDI4736), in Advanced Refractory Solid Tumors
The main purpose of this study is to evaluate the safety and tolerability of chemokine (C-X-C Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a and 1b in participants with advanced refractory solid tumors.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumor
  • Drug: LY2510924
    Administered SQ
  • Drug: Durvalumab
    Administered IV
  • Experimental: LY2510924 + Durvalumab
    LY2510924 given subcutaneously (SQ) in combination with durvalumab given intravenously (IV).
    Interventions:
    • Drug: LY2510924
    • Drug: Durvalumab
  • Experimental: LY2510924 + Durvalumab (Expansion 1)
    LY2510924 given SQ in combination with durvalumab given IV.
    Interventions:
    • Drug: LY2510924
    • Drug: Durvalumab
  • Experimental: LY2510924 + Durvalumab (Expansion 2)
    LY2510924 given SQ in combination with durvalumab given IV.
    Interventions:
    • Drug: LY2510924
    • Drug: Durvalumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
September 2017
September 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Phase 1a: Have histologic or cytologic confirmation of advanced solid tumor
  • Have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
  • Have adequate organ function
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have provided tissue from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by ≤3 years since last documented progression of disease
  • Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator

Exclusion Criteria:

  • Have a serious concomitant systemic disorder including human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active HCV, active autoimmune disorder or disease requiring high dose of steroids

    • Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea
    • Have evidence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active, noninfectious pneumonitis
    • Have an active infection requiring systemic therapy
  • Have had prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-L1, anti-PD-L2, or anticytotoxic T lymphocyte-associated antigen-4 antibody
  • Moderate or severe cardiovascular disease
  • Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
  • Have received a live vaccine within 30 days before the first dose of study treatment
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT02737072
16387
I2V-MC-CXAD ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
AstraZeneca
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
November 2017

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