Evidence map›Paper›PMID 27154357›Full record

Trial reportTargeted oncology2016

A Randomized, Open-Label Phase 2 Study of the CXCR4 Inhibitor LY2510924 in Combination with Sunitinib Versus Sunitinib Alone in Patients with Metastatic Renal Cell Carcinoma (RCC).

John D Hainsworth, James A Reeves, Joseph R Mace, Edward J Crane, Oday Hamid, John R Stille, Amy Flynt, Stephanie Roberson, John Polzer, Edward R Arrowsmith

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Targeted oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01391130 (Randomized, Multicenter, Open-label, Active-Controlled, Phase 2 Study of LY2510924 and Sunitinib Versus Sunitinib in Patients With Metastatic Renal Cell Carcinoma), which is not on this map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01391130 phase2terminatednot on this map

Randomized, Multicenter, Open-label, Active-Controlled, Phase 2 Study of LY2510924 and Sunitinib Versus Sunitinib in Patients With Metastatic Renal Cell Carcinoma

TypeinterventionalSponsorEli Lilly and CompanyRan2011 to 2017Enrolled110ConditionsMetastatic Clear Cell Renal Cell CarcinomaArmsLY2510924, Sunitinib
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Targeted therapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Trial
  4. Trial
  5. Development of an Optimized CXCR4-Targeting Theranostic Pair.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Article
  6. Review
  7. Modeling CAF-tumor interactions to overcome therapy resistance.Journal of experimental & clinical cancer research : CR · 2026
    Review
  8. Modulation of infiltrating CD206The European respiratory journal · 2025
    Article
  9. Review
  10. Review
  11. The role of CXC chemokines and receptors in breast cancer.Clinical and experimental medicine · 2025
    Review
  12. Selective PET imaging of CXCR4 using the AlEuropean journal of nuclear medicine and molecular imaging · 2025
    Article
  13. Review
  14. Review
  15. SubvertingBiology · 2024
    Review
  16. Article
  17. Targeting CXCR4/CXCL12 axis via [European journal of nuclear medicine and molecular imaging · 2024
    Article
  18. Small-molecule agents for cancer immunotherapy.Acta pharmaceutica Sinica. B · 2024
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

John D HainsworthSarah Cannon Research Institute/Tennessee Oncology, PLLC, 250 25th Ave N #100, Nashville, TN, 37203, USA. John.Hainsworth@scresearch.net.
James A ReevesFlorida Cancer Specialists, Fort Myers, FL, USA.
Joseph R MaceFlorida Cancer Specialists, St. Petersburg, FL, USA.
Edward J CraneOncology Hematology Care, Cincinnati, OH, USA.
Oday HamidEli Lilly and Company, Indianapolis, IN, USA.
John R StilleEli Lilly and Company, Indianapolis, IN, USA.
Amy FlyntPharPoint Research Inc, Durham, NC, USA.
Stephanie RobersonEli Lilly and Company, Indianapolis, IN, USA.
John PolzerEli Lilly and Company, Indianapolis, IN, USA.
Edward R ArrowsmithTennessee Oncology, Chattanooga, TN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe chemokine (C-X-C Motif) receptor 4 (CXCR4) and its ligand, stromal-cell derived factor-1 (SDF-1), are frequently overexpressed in a variety of solid tumors, and are believed to play important roles in the regulation of organ-specific metastasis, tumor growth, invasion, and survival. In this randomized Phase 2 trial, we evaluated the safety and efficacy of LY2510924 (LY), a peptide antagonist of CXCR4, combined with sunitinib (SUN) in the first-line treatment of advanced renal cell carcinoma (RCC). PATIENTS AND

methodsEligible patients were randomized (2:1) to receive LY (20 mg SC daily) + SUN (50 mg PO daily for 4 weeks followed by 2 weeks off) or SUN alone. Response was assessed after two cycles; patients continued treatment until tumor progression or intolerable toxicity. The study was powered to detect a 47 % increase in median progression-free survival (PFS).

resultsOne hundred eight patients were randomized and treated (LY + SUN, 72; SUN, 36); median duration of treatment of five cycles. Observed median PFS was 8.1 months with LY + SUN and 12.3 months with SUN; Bayesian time-to-event HR 1.23; 95 % credible interval: 0.74, 1.96. LY was well tolerated; the toxicity profile was typical of SUN. No efficacy differences were seen between treatments groups when subsets with high versus low levels of CXCR4 tumor expression were compared.

conclusionsThe addition of LY to SUN in the first-line treatment of metastatic RCC was well tolerated, but did not improve the PFS or overall survival (OS) vs. SUN alone. CXCR4 remains an unproven therapeutic target for the treatment of RCC. CLINICAL TRIAL: GOV IDENTIFIER: NCT01391130.

Indexed as

AgedAntineoplastic AgentsCarcinoma, Renal CellFemaleHumansIndolesMaleNeoplasm MetastasisPeptides, CyclicPyrrolesReceptors, CXCR4SunitinibAntineoplastic AgentsCXCR4 protein, humanIndolesLY2510924Peptides, CyclicPyrrolesReceptors, CXCR4Sunitinib

Identifiers

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.