Evidence map›Paper›PMID 33075165›Full record

ArticleCancer science2021

Phase I, multicenter, dose-escalation study of avadomide in adult Japanese patients with advanced malignancies.

Kiyohiko Hatake, Takaaki Chou, Toshihiko Doi, Yasuhito Terui, Harumi Kato, Takayuki Hirose, Sachiko Seo, Michael Pourdehnad, Yumi Ogaki, Hiroshi Fujimoto and 2 more

Open access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 32% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Article
  6. Population Pharmacokinetics of CC-122.Clinical pharmacology : advances and applications · 2021
    Article
  7. 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

12 authors at 8 institutions in 2 countries.

Kiyohiko HatakeLymphoma/Hematology Center, International University of Health and Welfare, Mita Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-4153-4987
Takaaki ChouDepartment of Hematology Oncology, Niigata Cancer Center Hospital, Niigata, Japan.
Toshihiko DoiDepartment of Experimental Therapeutics, National Cancer Center Hospital East, Chiba, Japan.
Yasuhito TeruiDepartment of Hematology Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Harumi KatoDepartment of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan.
Takayuki HiroseDepartment of Hematology Oncology, Niigata Cancer Center Hospital, Niigata, Japan.
Sachiko SeoDepartment of Hematology and Oncology, Dokkyo Medical University, Tochigi, Japan.
Michael PourdehnadBristol Myers Squibb, Princeton, NJ, USA.
Yumi OgakiCelgene K.K., A Bristol Myers Squibb Company, Tokyo, Japan.
Hiroshi FujimotoCelgene K.K., A Bristol Myers Squibb Company, Tokyo, Japan.
Patrick R HagnerBristol Myers Squibb, Princeton, NJ, USA.
Kazuhito YamamotoDepartment of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan.
Aichi Cancer Center · JPBristol-Myers Squibb (Japan) · JPBristol-Myers Squibb (United States) · USNiigata Cancer Center Hospital · JPDokkyo Medical University · JPJapanese Foundation For Cancer Research · JPMita Hospital · JPNational Cancer Center Hospital East · JP

Funding

Bristol Myers Squibb Company, Princeton, NJ, USA
6 · The paper itself

Abstract

Non-Hodgkin lymphoma (NHL) treated with chemoimmunotherapy has limited efficacy in some patients, resulting in relapsed or refractory disease. Avadomide (CC-122) is a novel cereblon-binding agent that exhibits antilymphoma and immune-modulation activities with a biological profile distinct from similar agents, such as lenalidomide. This phase I multicenter study evaluated avadomide in Japanese patients with advanced solid tumors or NHL. Fourteen patients with NHL and one with a solid tumor (esophageal carcinoma), were enrolled in four dose-escalation cohorts using a 3 + 3 design. Primary endpoints included safety, dose-limiting toxicities (DLT), maximum-tolerated dose and/or recommended phase II dose (RP2D), and pharmacokinetics. Secondary endpoints included overall response rate (ORR) and duration of response. One patient with NHL experienced DLT, which included face edema, pharyngeal edema, and tumor flare (all grade 1) that led to a dose reduction. Eleven patients had grade ≥3 treatment-emergent adverse events, most frequently decreased neutrophil count (33%) and decreased lymphocyte count (20%). The ORR in patients with NHL (n = 13) was 54%, including four complete and three partial responses. The best response for the solid tumor patient was progressive disease. Avadomide dose intensity was consistent across cohorts, and the 3-mg dose given five consecutive days/week was established as the RP2D. This phase I study identified a tolerable dose of avadomide, with an acceptable toxicity profile and clinically meaningful efficacy in Japanese patients with previously treated NHL.

Indexed as

AgedAntineoplastic AgentsDose-Response Relationship, DrugEsophageal NeoplasmsFemaleHumansJapanLymphoma, Non-HodgkinMaleMaximum Tolerated DoseMiddle AgedPiperidonesQuinazolinones3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dioneAntineoplastic AgentsPiperidonesQuinazolinonesavadomideCC-122cereblondose-escalationnon-Hodgkin lymphomaphase I

Identifiers

PMID33075165
PMCPMC7780008
OpenAlexW3093377311

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.