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NCT02193633: TAX-TORC

A Phase I Trial of the Combination of AZD2014 and Weekly Paclitaxel.

Completed Phase 1 Last updated 26 September 2024
What this trial tests

Phase 1 trial testing AZD2014 3 on/4 off & weekly paclitaxel in Advanced Cancer in 90 participants. Completed in 15 November 2017.

Timeline
26 April 2013
Primary endpoint
15 November 2017
15 November 2017

Quick facts

Lead sponsorRoyal Marsden NHS Foundation Trust
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment90
Start date26 April 2013
Primary completion15 November 2017
Estimated completion15 November 2017
Sites4 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

Adults 18 to 75, any sex, with Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I study to evaluate the safety and toxicity profile of AZD2014, a novel anticancer agent, in combination with paclitaxel. AZD2014 will be given orally, twice daily at a starting dose of 25 mg per day for 3 days on, 4 days off with a weekly infusion of 80 mg of paclitaxel for 6 weeks followed by a treatment break of one week, therefore each cycle will be 7 weeks long. Cohorts of three patients will be treated at this dose of AZD2014 and then at 50mg and 75 mg providing is it safe to do so. Once we have determined the maximum tolerated dose (MTD) using the 3 days on, 4 days off schedule of AZD2014, patients will be given AZD2014 2 days on, 5 days with their paclitaxel infusion. Patients will be enrolled in cohorts of three to evaluate three escalating doses of AZD2014 to determine the MTD for the 2 days on, 5 days off schedule. On completion of the dose escalation phase of the study patients with ovarian cancer and squamous cell lung cancer will be treated at the MTD established for each dosing schedule. A minimum of 10 ovarian cancer patients and 15 squamous cell lung patients will be enrolled to the 3 days on, 4 days off schedule. Whilst a minimum of 10 squamous cell cancer patients will be enrolled to the 2 days on, 5 days off schedule to further assess the tolerability of the combination of AZD2014 and paclitaxel.

Publications & conference data

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

  1. Targeting mTOR for cancer therapy.
    Hua H, Kong Q, Zhang H, Wang J, et al · · 2019 · cited 678× · PMID 31277692 · DOI 10.1186/s13045-019-0754-1
  2. Recent advances and limitations of mTOR inhibitors in the treatment of cancer.
    Ali ES, Mitra K, Akter S, Ramproshad S, et al · · 2022 · cited 115× · PMID 36109789 · DOI 10.1186/s12935-022-02706-8
  3. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
    Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
  4. Clear cell carcinoma of the ovary: molecular insights and future therapeutic perspectives.
    Mabuchi S, Sugiyama T, Kimura T. · · 2016 · cited 98× · PMID 27029752 · DOI 10.3802/jgo.2016.27.e31
  5. Targeting the PI3K/AKT/mTOR pathway in epithelial ovarian cancer, therapeutic treatment options for platinum-resistant ovarian cancer.
    Rinne N, Christie EL, Ardasheva A, Kwok CH, et al · · 2021 · cited 80× · PMID 35582310 · DOI 10.20517/cdr.2021.05
  6. PIK3CA mutations enable targeting of a breast tumor dependency through mTOR-mediated MCL-1 translation.
    Anderson GR, Wardell SE, Cakir M, Crawford L, et al · · 2016 · cited 52× · PMID 27974663 · DOI 10.1126/scitranslmed.aae0348
  7. A Review of mTOR Pathway Inhibitors in Gynecologic Cancer.
    de Melo AC, Paulino E, Garces ÁH. · · 2017 · cited 36× · PMID 28286604 · DOI 10.1155/2017/4809751
  8. Vistusertib (dual m-TORC1/2 inhibitor) in combination with paclitaxel in patients with high-grade serous ovarian and squamous non-small-cell lung cancer.
    Basu B, Krebs MG, Sundar R, Wilson RH, et al · · 2018 · cited 29× · PMID 30016392 · DOI 10.1093/annonc/mdy245

Verify or expand the search:

Other recruiting trials for Advanced Cancer

Currently open trials in the same condition.

Other Royal Marsden NHS Foundation Trust 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/NCT02193633.

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