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NCT01748825 · ClinicalTrials.gov registry record · Phase 1
AZD1775 for Advanced Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT01748825: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01748825 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 67 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01748825, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
BACKGROUND: * Wee1 is a tyrosine kinase involved in the phosphorylation and inactivation of cyclin-dependent kinase 1 (CDK1/CDC2)-bound cyclin B, resulting in G2 cell cycle arrest in response to deoxyribonucleic acid (DNA) damage to allow time for DNA repair. Recent preclinical data additionally implicates Wee1 in maintenance of genomic integrity during S phase. * Adavosertib (AZD1775) is a selective inhibitor of Wee1 kinase. Recent preclinical model data additionally show single agent anti-tumor activity in multiple cancer cell lines and tumor xenografts. * Preliminary data show AZD1775 is tolerable at lower doses in combination with chemotherapeutic agents. We propose to demonstrate single-agent activity for AZD1775. PRIMARY OBJECTIVE: * To establish the safety and tolerability of single-agent AZD1775 in patients with refractory solid tumors * To determine the pharmacokinetics of AZD1775 in patients with refractory solid tumors SECONDARY OBJECTIVES: * To determine the effect of AZD1775 on markers of DNA damage and apoptosis in tumor tissue and circulating tumor cells * To evaluate the antitumor activity of AZD1775 in patients with refractory solid tumors EXPLORATORY OBJECTIVES: -To identify tumor genomic alterations and gene expression patterns potentially associated with AZD1775 antitumor activity ELIGIBILITY: * Patients must have histologically confirmed solid tumors for which all standard therapy known to prolong survival have failed, or for which standard therapies do not exist. * No major surgery, radiation, or chemotherapy within 3 weeks or (5 half-lives, whichever is shorter) prior to entering the study. * Adequate organ function STUDY DESIGN: * This study will follow a traditional 3+3 design. * In Arm A starting at dose level 1, AZD1775 will be administered orally, twice a day (BID), for 5 doses (Day (D) 1-3) during each cycle. Starting at dose level 2 and onwards, AZD1775 will be administered orally, BID, for 5 doses for the first 2 weeks of ea
Interventions
- DRUG MK-1775 (AZD1775)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2012-12-19 |
| Est. Completion | 2020-05-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01748825
The ClinicalTrials.gov registry entry for NCT01748825 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MK-1775 (AZD1775) is the first listed.
NCT01748825 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01748825 about?
NCT01748825 is a clinical study titled "AZD1775 for Advanced Solid Tumors". BACKGROUND: * Wee1 is a tyrosine kinase involved in the phosphorylation and inactivation of cyclin-dependent kinase 1 (CDK1/CDC2)-bound cyclin B, resulting in G2 cell cycle arrest in response to deoxyribonucleic acid (DNA) damage to allow time for DNA repair. Recent preclinical data additionally im...
What is the current status of trial NCT01748825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2012-12-19. Estimated completion is 2020-05-19.
What interventions are being tested in trial NCT01748825?
The interventions under investigation include: MK-1775 (AZD1775) (DRUG).
Who is sponsoring clinical trial NCT01748825?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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