Evidence map›Paper›PMID 25695690›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2015

Phase II Study of Nilotinib in Melanoma Harboring KIT Alterations Following Progression to Prior KIT Inhibition.

Richard D Carvajal, Donald P Lawrence, Jeffrey S Weber, Thomas F Gajewski, Rene Gonzalez, Jose Lutzky, Steven J O'Day, Omid Hamid, Jedd D Wolchok, Paul B Chapman and 10 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00788775 (A Phase II Study of Nilotinib), which is not on this map. Cited by 65 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 1 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.

NCT00788775 phase2completednot on this map

A Phase II Study of Nilotinib (AMN107) In TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral or Chronically Sun Damaged Melanoma

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2009 to 2014Enrolled20ConditionsMucosal Lentiginous Melanoma, Acral Melanoma, MelanomaArmsNilotinib
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Phase II Study of Sunitinib in Tumors WithJCO precision oncology · 2024
    Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Article
  10. Review
  11. Article
  12. Therapeutic advances of targeting receptor tyrosine kinases in cancer.Signal transduction and targeted therapy · 2024
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Anorectal mucosal melanoma.Seminars in colon & rectal surgery · 2023
    Article
  18. Review
  19. Review
  20. Review

5 more citing papers are in PubMed but not listed here.

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

20 authors.

Richard D CarvajalMemorial Sloan Kettering Cancer Center, New York, New York. Weill Medical College of Cornell University, New York, New York.
Donald P LawrenceMassachusetts General Hospital, Boston, Massachusetts.
Jeffrey S WeberH. Lee Moffitt Cancer Center, Tampa, Florida.
Thomas F GajewskiThe University of Chicago, Chicago, Illinois.
Rene GonzalezThe University of Colorado Cancer Center, Aurora, Colorado.
Jose LutzkyMount Sinai Comprehensive Cancer Center, Miami Beach, Florida.
Steven J O'DayBeverly Hills Cancer Center, Beverly Hills, California.
Omid HamidAngeles Clinic and Research Institute, Los Angeles, California.
Jedd D WolchokMemorial Sloan Kettering Cancer Center, New York, New York. Weill Medical College of Cornell University, New York, New York.
Paul B ChapmanMemorial Sloan Kettering Cancer Center, New York, New York. Weill Medical College of Cornell University, New York, New York.
Ryan J SullivanMassachusetts General Hospital, Boston, Massachusetts.
Jerrold B TeitcherMemorial Sloan Kettering Cancer Center, New York, New York.
Nikhil RamaiyaDana Farber Cancer Institute, Boston, Massachusetts.
Anita Giobbie-HurderDana Farber Cancer Institute, Boston, Massachusetts.
Cristina R AntonescuMemorial Sloan Kettering Cancer Center, New York, New York.
Michael C HeinrichOregon Health and Science University, Portland, Oregon.
Boris C BastianThe University of California San Francisco, San Francisco, California.
Christopher L CorlessOregon Health and Science University, Portland, Oregon.
Jonathan A FletcherDana Farber Cancer Institute, Boston, Massachusetts.
F Stephen HodiDana Farber Cancer Institute, Boston, Massachusetts. Stephen_hodi@dfci.harvard.edu.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
TUMOR DEVELOPMENT AND PROGRESSION IN HUMAN MELANOCYTESP01CA025874 · NCI · WISTAR INSTITUTE · PI HERLYN, MEENHARD F · 1985 to 2015
$19.0M
NCI NIH HHS P01 CA025874NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeAlthough durable responses can be achieved with tyrosine kinase inhibitors such as imatinib in melanomas harboring KIT mutations, the efficacy of alternative inhibitors after progression to imatinib and the activity of these agents on brain metastases are unknown. EXPERIMENTAL

designWe conducted a phase II study of nilotinib 400 mg twice a day in two cohorts of patients with melanomas harboring KIT mutations or amplification: (A) those refractory or intolerant to a prior KIT inhibitor; and (B) those with brain metastases. The primary endpoint was 4-month disease control rate. Secondary endpoints included response rate, time-to-progression (TTP), and overall survival (OS). A Simon two-stage and a single-stage design was planned to assess for the primary endpoint in cohorts A and B, respectively.

resultsTwenty patients were enrolled and 19 treated (11 in cohort A; 8 in cohort B). Three patients on cohort A [27%; 95% confidence interval (CI), 8%-56%] and 1 on cohort B (12.5%; 90% CI, 0.6%-47%) achieved the primary endpoint. Two partial responses were observed in cohort A (18.2%; 90% CI, 3%-47%); none were observed in cohort B. The median TTP and OS was 3.3 (90% CI, 2.1-3.9 months) and 9.1 months (90% CI, 4.3-14.2 months), respectively, in all treated patients.

conclusionsNilotinib may achieve disease control in patients with melanoma harboring KIT alterations and whose disease progressed after imatinib therapy. The efficacy of this agent in KIT-altered melanoma with brain metastasis is limited.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBrain NeoplasmsDisease ProgressionDrug Resistance, NeoplasmFemaleHumansMaleMelanomaMiddle AgedProto-Oncogene Proteins c-kitPyrimidinesSkin NeoplasmsTreatment OutcomeAntineoplastic AgentsnilotinibProto-Oncogene Proteins c-kitPyrimidines

Identifiers

PMID25695690
PMCPMC5013827

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.