Phase 1
Completed N=17
An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.
Lymphoma, Mantle-Cell
Source: ClinicalTrials.gov NCT00420056 ↗
Enrolled (actual)
17
Serious AEs
17.7%
Results posted
Jun 2015
Primary outcomePrimary: Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21 — -0.25034 correlation coefficient — p=0.4854
Summary
This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21 |
-0.25034 | 0.4854 |
| PRIMARY Correlation Coefficient Between Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21 |
0.13551 | 0.7090 |
| PRIMARY Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21 |
9.964; 9.049; -4.551; -2.271 | — |
| PRIMARY Correlation Between Positron Emission Tomography (PET) Response and Progression-Free Survival (PFS) |
— | — |
| PRIMARY Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR) |
1; 2; 7; 4; 1; 2 | — |
| PRIMARY Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Baseline |
47.9 | — |
| PRIMARY Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21 |
7.2 | — |
| PRIMARY Ki-67 Composite Score at Baseline |
191.2 | — |
| PRIMARY Ki-67 Composite Score at Cycle 1 Day 21 |
78.5 | — |
| PRIMARY Cyclin D1 Composite Score at Baseline |
165.0 | — |
| PRIMARY Cyclin D1 Composite Score at Cycle 1 Day 21 |
124.2 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities |
16 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events by Severity |
4; 2; 7; 3; 1 | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
16; 2 | — |
| SECONDARY Progression-Free Survival (PFS) |
5.5 | — |
| SECONDARY Percentage of Participants With Objective Response |
18.8 | — |
| SECONDARY Duration of Response (DR) |
— | — |
| SECONDARY Time to Tumor Progression (TTP) |
5.5 | — |
| SECONDARY Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21 |
0.27677; -0.69081; -0.55533; 0.28767; -0.18526 | 0.5954 |
Eligibility Criteria
Inclusion Criteria
- Histologically documented MCL.
- Must have received at least one prior therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Adequate organ function as outlined in the protocol.
Exclusion Criteria
- Major surgery, radiation therapy, or systemic therapy within 4 weeks of study enrollment.
- Prior radiation therapy to >25% of the bone marrow (whole pelvis is 25%).
- Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
Data sourced from ClinicalTrials.gov (NCT00420056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.