drugset / Trial / NCT01037790
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with refractory solid tumors.
Timeline
- Start
- 2009-10
- Primary completion
- 2019-10
- Completion
- 2019-10
Publications
- Karasic TB, O'Hara MH, Teitelbaum UR, Damjanov N, Giantonio BJ, d'Entremont TS, Gallagher M, Zhang PJ, O'Dwyer PJ. Phase II Trial of Palbociclib in Patients with Advanced Esophageal or Gastric Cancer. Oncologist. 2020 Dec;25(12):e1864-e1868. doi: 10.1634/theoncologist.2020-0681. Epub 2020 Aug 8.
- McAndrew NP, Dickson MA, Clark AS, Troxel AB, O'Hara MH, Colameco C, Gallager M, Gramlich K, Zafman K, Vaughn D, Schwartz GK, O'Dwyer PJ, DeMichele A. Early treatment-related neutropenia predicts response to palbociclib. Br J Cancer. 2020 Sep;123(6):912-918. doi: 10.1038/s41416-020-0967-7. Epub 2020 Jul 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palbociclib | Small molecule | 125 mg | Oral |
Indications
HER2 positive breast carcinoma
Her2-receptor negative breast cancer
adult central nervous system germ cell tumor
adult teratoma
benign teratoma
colon adenocarcinoma
estrogen-receptor negative breast cancer
estrogen-receptor positive breast cancer
extragonadal nonseminomatous germ cell tumor
extragonadal seminoma
female breast carcinoma
immature ovarian teratoma
immature teratoma
male breast carcinoma
malignant testicular germ cell tumor
mature ovarian teratoma
melanoma
ovarian monodermal and highly specialized teratoma
progesterone-receptor negative breast cancer
progesterone-receptor positive breast cancer
rectum adenocarcinoma
testicular teratoma