A Phase 1 Study of COTI-2 for the Treatment of Advanced or Recurrent Gynecologic Malignancies and Head and Neck Squamous Cell Carcinoma

Trial Profile

A Phase 1 Study of COTI-2 for the Treatment of Advanced or Recurrent Gynecologic Malignancies and Head and Neck Squamous Cell Carcinoma

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 May 2018

At a glance

  • Drugs Cisplatin (Primary) ; COTI 2 (Primary)
  • Indications Cervical cancer; Colorectal cancer; Endometrial cancer; Fallopian tube cancer; Gynaecological cancer; Head and neck cancer; Lung cancer; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Squamous cell cancer
  • Focus Adverse reactions; First in man
  • Sponsors Cotinga Pharmaceuticals
  • Most Recent Events

    • 24 May 2018 According to a Cotinga Pharmaceuticals media release, as per the protocol amendment, the primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacokinetics and various signals of efficacy.
    • 24 May 2018 According to a Cotinga Pharmaceuticals media release, the company has received approval to amended the protocol of this trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers. Initially COTI-2 will be evaluated in combination with standard of care cisplatin in up to 30 patients with any of ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma.
    • 20 Mar 2018 According to a Cotinga Pharmaceuticals media release, pending regulatory approval and subject to sufficient financing, the company expects to implement the submitted protocol amendment for this trial in May 2018 and dose the first patient with a combination therapy regimen.
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