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NCT02530437

Taladegib, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Localized Esophageal or Gastroesophageal Junction Cancer

Terminated Phase 1, PHASE2 Results posted Last updated 10 July 2023
What this trial tests

Phase 1, PHASE2 trial testing Carboplatin in Gastroesophageal Junction Adenocarcinoma in 7 participants. Terminated before completion.

Timeline
7 March 2017
Primary endpoint
7 January 2022
7 January 2022

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment7
Start date7 March 2017
Primary completion7 January 2022
Estimated completion7 January 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Gastroesophageal Junction Adenocarcinoma or Stage IB Esophageal Adenocarcinoma AJCC v7. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pathologic Complete Response Rate (Phase II) Primary · Up to 4 years and 10 months

A pathologic complete response (pathCR) rate of at least 35% (\>= 40% is desirable) will be of interest. The pathCR rate in each of the treatment step will be estimated, along with the 95% confidence interval.

Complete Response
GroupValue95% CI
Phase 1 B4
Less than complete response
GroupValue95% CI
Phase 1 B3
Relapse-free Survival Secondary · Up to 4 years and 10 months

Kaplan-Meier method will be used to estimate the probabilities of relapse-free survival.

GroupValue95% CI
Phase 1 B142 – 28
Overall Survival Secondary · Up to 4 years and 10 months

Kaplan-Meier method will be used to estimate the probabilities of overall survival.

GroupValue95% CI
Phase 1 B2720 – 49

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to up to 4 years and 10 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1B
Serious: 3/7 (43%)
Deaths: 7/7

Serious adverse events (3 terms)

ReactionSystemPhase 1B
FeverInfections and infestations
Gastric hemorrhageGastrointestinal disorders
Ischemia cerebrovascularVascular disorders
Other adverse events (87 terms — click to expand)

ReactionSystemPhase 1B
NauseaGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
Weight lossInvestigations
DysphagiaGastrointestinal disorders
FatigueGeneral disorders
DizzinessNervous system disorders
EsophagitisGastrointestinal disorders
ConstipationGastrointestinal disorders
White blood cell decreasedInvestigations
Neutrophil count decreasedInvestigations
VomitingGastrointestinal disorders
HeadacheNervous system disorders
OdynophagiaGastrointestinal disorders
DysgeusiaNervous system disorders
HypomagnesemiaMetabolism and nutrition disorders
Sore throatRespiratory, thoracic and mediastinal disorders
DehydrationMetabolism and nutrition disorders
HypotensionVascular disorders
CoughRespiratory, thoracic and mediastinal disorders
WeaknessGeneral disorders
Bruises EasilyBlood and lymphatic system disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Light HeadednessNervous system disorders
Peripheral sensory neuropathyNervous system disorders
DiarrheaGastrointestinal disorders
Mucositis oralGastrointestinal disorders
Abdominal painGastrointestinal disorders
Rash maculo-papularSkin and subcutaneous tissue disorders
Taste Alteration: Metallic TasteNervous system disorders
Esophageal PainGastrointestinal disorders
HyponatremiaMetabolism and nutrition disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Chest PainCardiac disorders
ChillsGeneral disorders
Visual changesEye disorders
MucusRespiratory, thoracic and mediastinal disorders
TinnitusEar and labyrinth disorders
InsomniaPsychiatric disorders
Abdominal distensionGastrointestinal disorders
Sinus tachycardiaCardiac disorders

Most-reported serious reactions: Fever, Gastric hemorrhage, Ischemia cerebrovascular.

Data from ClinicalTrials.gov NCT02530437 adverse events section.

Sponsor's own description

This phase IB/II trial studies the side effects of taladegib, paclitaxel, carboplatin, and external beam radiation therapy and to see how well they work in treating patients with esophageal or gastroesophageal junction cancer found only in the tissue or organ where it began, and has not spread to nearby lymph nodes or to other parts of the body (localized). Taladegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving taladegib, paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting cancer stem cell pathways for cancer therapy.
    Yang L, Shi P, Zhao G, Xu J, et al · · 2020 · cited 1354× · PMID 32296030 · DOI 10.1038/s41392-020-0110-5
  2. Targeting the Sonic Hedgehog Signaling Pathway: Review of Smoothened and GLI Inhibitors.
    Rimkus TK, Carpenter RL, Qasem S, Chan M, et al · · 2016 · cited 411× · PMID 26891329 · DOI 10.3390/cancers8020022
  3. Hedgehog Pathway Inhibitors as Targeted Cancer Therapy and Strategies to Overcome Drug Resistance.
    Nguyen NM, Cho J. · · 2022 · cited 88× · PMID 35163655 · DOI 10.3390/ijms23031733
  4. Safety and Tolerability of Sonic Hedgehog Pathway Inhibitors in Cancer.
    Carpenter RL, Ray H. · · 2019 · cited 77× · PMID 30649745 · DOI 10.1007/s40264-018-0777-5
  5. Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas.
    Jain S, Song R, Xie J. · · 2017 · cited 72× · PMID 28352196 · DOI 10.2147/ott.s130910
  6. Recent Advances in the Clinical Targeting of Hedgehog/GLI Signaling in Cancer.
    Xie H, Paradise BD, Ma WW, Fernandez-Zapico ME. · · 2019 · cited 61× · PMID 31035664 · DOI 10.3390/cells8050394
  7. Targeting the Hedgehog Pathway in Cancer: Current Evidence and Future Perspectives.
    Girardi D, Barrichello A, Fernandes G, Pereira A. · · 2019 · cited 52× · PMID 30759860 · DOI 10.3390/cells8020153
  8. The Role of Smoothened in Cancer.
    Jeng KS, Sheen IS, Leu CM, Tseng PH, et al · · 2020 · cited 47× · PMID 32962123 · DOI 10.3390/ijms21186863

Verify or expand the search:

Other trials of Carboplatin

Trials testing the same drug.

Other recruiting trials for Gastroesophageal Junction Adenocarcinoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02530437.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing