Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Dose Escalation Study of Hydroxyurea in Combination With SCH900776 in Advanced Malignant Solid Tumors
This is an open label Phase I study with two parts. Part Two with SCH900776 in combination
with hydroxyurea will not be pursued at this time.
Part One investigates monotherapy with oral hydroxyurea. The primary objective is to
determine whether a tolerated dose (TD) of hydroxyurea as a single agent can increase the
percentage of tumor cells in S and G2 phase of the cell cycle. For this reason, all patients
in Part One must have a tumor lesion accessible for a skin punch biopsy. Tumor biopsies will
be obtained on two separate occasions: prior to hydroxyurea and at 16-18h after starting
hydroxurea therapy on day 1 only.
A baseline 12-lead ECG will be obtained from each study participant. Single-agent
hydroxyurea will be administered on days 1, 8 and 15 of a 28 day cycle, for ONE cycle only.
On these days oral hydroxyurea will be started in the late afternoon and administered every
4 hours for a total of 6 doses.
Venous (up to 10 mL) blood samples will be obtained at time zero (pretreatment), 30 min, 1h,
1.5 2, 2.5, 3.0, 3.5 and 4h following the first oral dose of hydroxyurea, and pretreatment
and at the same times following the sixth oral dose of hydroxyurea (i.e., 20, 20.5, 21,
21.5, 22, 22.5, 23, 23.5 and 24 h).
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04972981 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT05086822 -
A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03260322 -
A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT06040541 -
Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05862831 -
Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03641794 -
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT03665129 -
IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06413680 -
A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05914116 -
A Study of DB-1311 in Advanced/Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01693562 -
A Phase 1/2 Study to Evaluate MEDI4736
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04387916 -
A Study of KC1036 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT04095273 -
Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug
|
Phase 1 | |
| Not yet recruiting |
NCT03692520 -
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02997176 -
An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
|
Phase 1 | |
| Recruiting |
NCT04446260 -
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT02253992 -
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06076291 -
An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03545971 -
A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.
|
Phase 1 |