Other Clinical Trial - Oral Paclitaxel Efficacy Safety & PK in Recurrent &

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03947736` - Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR
Completed	`NCT03109249` - Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer	Phase 1
Active, not recruiting	`NCT03315364` - Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy	Phase 2/Phase 3

See also

Status

Clinical Trial

Phase

Recruiting

NCT03947736 - Dynamic Monitoring of HER2 and ctDNA Specific Mutations in Patients With Recurrent or Metastatic Breast Cancer by Digital PCR

Completed

NCT03109249 - Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer

Phase 1

Active, not recruiting

NCT03315364 - Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy

Phase 2/Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03326102
Study type	Interventional
Source	Daehwa Pharmaceutical Co., Ltd.
Contact
Status	Completed
Phase	Phase 2
Start date	July 6, 2018
Completion date	December 13, 2022

Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer — OPERA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms