Evidence map›Paper›PMID 27862097›Full record

ArticleThe Prostate2017

Phase Ib Trial of Cabazitaxel and Tasquinimod in Men With Heavily Pretreated Metastatic Castration Resistant Prostate Cancer (mCRPC): The CATCH Trial.

Andrew J Armstrong, Michael S Humeniuk, Patrick Healy, Russell Szmulewitz, Carolyn Winters, Julie Kephart, Michael R Harrison, Elia Martinez, Kelly Mundy, Susan Halabi and 1 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in The Prostate, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
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

11 authors.

Andrew J ArmstrongDivisions of Medical Oncology and Urology, Departments of Medicine and Surgery, Duke Cancer Institute, Durham, North Carolina.
Michael S HumeniukDivisions of Medical Oncology and Urology, Departments of Medicine and Surgery, Duke Cancer Institute, Durham, North Carolina.
Patrick HealyDepartment of Biostatistics, Duke University, Durham, North Carolina.
Russell SzmulewitzDepartment of Medicine, University of Chicago, Chicago, Illinois.
Carolyn WintersDivisions of Medical Oncology and Urology, Departments of Medicine and Surgery, Duke Cancer Institute, Durham, North Carolina.
Julie KephartDivisions of Medical Oncology and Urology, Departments of Medicine and Surgery, Duke Cancer Institute, Durham, North Carolina.
Michael R HarrisonDivisions of Medical Oncology and Urology, Departments of Medicine and Surgery, Duke Cancer Institute, Durham, North Carolina.
Elia MartinezDepartment of Medicine, University of Chicago, Chicago, Illinois.
Kelly MundyDivisions of Medical Oncology and Urology, Departments of Medicine and Surgery, Duke Cancer Institute, Durham, North Carolina.
Susan HalabiDepartment of Biostatistics, Duke University, Durham, North Carolina.
Daniel GeorgeDivisions of Medical Oncology and Urology, Departments of Medicine and Surgery, Duke Cancer Institute, Durham, North Carolina.

Funding

Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI JOHN N. NORTON · 1985 to 2026
$174.8M
NCI NIH HHS P30 CA014236
6 · The paper itself

Abstract

backgroundTasquinimod is an immunomodulating and anti-antiangiogenic oral agent with anti-prostate cancer activity in preclinical studies and in clinical trials of men with metastatic castration resistant prostate cancer (mCRPC), including single agent activity and in combination with taxanes. We sought to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of tasquinimod in combination with cabazitaxel and prednisone in men with chemorefractory mCRPC.

methodsMen with mCRPC who had failed prior docetaxel chemotherapy received cabazitaxel 25 mg/m

resultsWe enrolled 25 men with chemorefractory mCRPC. The RP2D was 0.5 mg tasquinimod based on excess DLTs (two of three men) observed at dose level 3 (1.0 mg) including grade 3 sensory neuropathy and grade 3 atrial fibrillation. Dose level 2 was expanded to 14 men, where 3 DLTs were observed: grade 3 fatigue, grade 4 febrile neutropenia, and grade 3 liver function abnormalities. The proportion of men with a ≥30% PSA decline was 63% and the median composite progression-free survival (PFS) was 8.5 months (95% CI 4.2-16.4 months) based on 12 PFS events. The median number of cycles of cabazitaxel was 6 (range 1-13), with six men receiving >10 cycles. Best overall RECIST responses (CR + PR) were observed in three men (12%), with stable disease in 12 (48%). No pharmacokinetic interactions were observed.

conclusionsWe determined the RP2D of tasquinimod combined with cabazitaxel to be 0.5 mg daily following a 3 week lead-in of tasquinimod 0.25 mg with growth factor support. No unexpected toxicities occurred. Prostate 77: 385-395, 2017. © 2016 Wiley Periodicals, Inc.

Indexed as

Disease ProgressionAgedAntineoplastic Combined Chemotherapy ProtocolsHumansMaleMiddle AgedProspective StudiesProstatic Neoplasms, Castration-ResistantQuinolonesSurvival RateTaxoidsTreatment OutcomecabazitaxelQuinolonestasquinimodTaxoidsangiogenesiscabazitaxelchemotherapyclinical trialimmunotherapymCRPCphase Iprostate cancertasquinimod

Identifiers

PMID27862097
PMCPMC6309626

What OpenQuestion holds

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Registered trials

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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.