WHO ICTRP trial
A study to investigate the safety, and effect of G1T38 on breast cancer when…
EUCTR2016-001485-29-BG · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2016-001485-29-BG |
|---|---|
| Public title | A study to investigate the safety, and effect of G1T38 on breast cancer when used in combination with Fulvestrant and to investigate level of G1T38 in the blood during treatment. |
| Scientific title | Phase 1/2 Safety, Pharmacokinetic, and Antitumor Activity Study of G1T38 in Combination with Fulvestrant in Patients with Hormone Receptor-Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer after Endocrine Failure |
| Primary sponsor | G1 Therapeutics, Inc |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Romania;Czechia;Moldova, Republic of;United Kingdom;Georgia;Bulgaria |
| Conditions | Hormone Receptor-Positive, HER2 Negative Metastatic Breast Cancer after Endocrine Failure MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and… |
| Interventions | Product Name: G1T38 Di-HCl Product Code: G1T38 Pharmaceutical Form: Capsule INN or Proposed INN: G1T38 Di-HCl Current Sponsor code: G1T38 Di-HCl Other descriptive name: G1T38 Concentration unit: mg milligram(s) Concentration type: equal… |
| Registration date | Nov 25, 2016 |
| Target size | 132 |
| Secondary IDs | G1T38-02;2016-001485-29-GB |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: