Trial · NCT00150462
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies
NCT00150462, Phase 1, Completed, Amgen; results first posted 2015-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies. Trials, record NCT00150462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00150462
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies
- NCT number
- NCT00150462
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 48 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Waldenstrom's Macroglobulinemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Interventions
- Carfilzomib, Dexamethasone
- First posted
- 2005-09-08
- Last updated
- 2017-05-02
- Results first posted
- 2015-12-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | 28 days | A DLT was defined as any of the following occurring in the first 28 days of study participation: Nonhematologic: * \> Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support * Febrile neutropenia (ANC \< 1.0 × 10ˆ9/L with a fever ≥ 38.3°C) * Grade 4 thrombocytopenia (platelets \< 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0. |
| Primary | Maximum Observed Plasma Concentration of Carfilzomib (Cmax) | Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose. | |
| Primary | Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax) | Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose. | |
| Primary | Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib | Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose. | |
| Primary | Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib | Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose. | |
| Secondary | Best Clinical Response to Treatment | From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase. | Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows: * Complete response: total resolution of measurable disease parameters. * Partial response: a ≥ 50% resolution without the appearance of new disease. * Stable disease: between \< 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease. * Progressive disease: an increase of \> 25% in measurable disease parameters. Best clinical response is the best response observed from the start of study treatment until disease progression or death. |
| Secondary | Duration of Response | From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase. | Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median duration of response was calculated using the Kaplan-Meier method. |
| Secondary | Time to Progression | From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase. | Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment. Median time to progression was calculated using the Kaplan-Meier method. |
| Secondary | Progression-free Survival | From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase. | Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities (DLTs) | 28 days | Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib | participants | NUMBER |
| PRIMARY | Maximum Observed Plasma Concentration of Carfilzomib (Cmax) | Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose. | Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses. | ng/mL | MEAN |
| SECONDARY | Best Clinical Response to Treatment | From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase. | Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment. | participants | NUMBER |
| SECONDARY | Duration of Response | From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase. | Biologic response-evaluable participants with an objective response | days | MEDIAN |
| SECONDARY | Time to Progression | From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase. | Biologic response-evaluable population | days | MEDIAN |
| SECONDARY | Progression-free Survival | From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase. | Biologic response-evaluable population | days | MEDIAN |
| PRIMARY | Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax) | Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose. | Participants with available pharmacokinetic (PK) data. Tmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses. | minutes | MEAN |
| PRIMARY | Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib | Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose. | Participants with available pharmacokinetic (PK) data. AUClast was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses. | ng*minute/mL | MEAN |
| PRIMARY | Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib | Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose. | Participants with available pharmacokinetic (PK) data. AUCinf was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses. | ng*minute/mL | MEAN |
Source ClinicalTrials.gov
Results by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 1.2 mg/m² | 1 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 2.4 mg/m² | 0 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 4.0 mg/m² | 0 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 6.0 mg/m² | 0 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 8.4 mg/m² | 0 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 11.0 mg/m² | 0 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 15.0 mg/m² | 0 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 20.0 mg/m² | 1 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 27.0 mg/m² | 1 | participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | CFZ 20/27 mg/m² | 0 | participants |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CFZ 1.2 mg/m² | 3 | |
| Overall Study | STARTED | CFZ 2.4 mg/m² | 3 | |
| Overall Study | STARTED | CFZ 4.0 mg/m² | 4 | |
| Overall Study | STARTED | CFZ 6.0 mg/m² | 3 | |
| Overall Study | STARTED | CFZ 8.4 mg/m² | 3 | |
| Overall Study | STARTED | CFZ 11.0 mg/m² | 4 | |
| Overall Study | STARTED | CFZ 15.0 mg/m² | 3 | |
| Overall Study | STARTED | CFZ 20.0 mg/m² | 8 | |
| Overall Study | STARTED | CFZ 27.0 mg/m² | 6 | |
| Overall Study | STARTED | CFZ 20/27 mg/m² | 7 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events2,915
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | CFZ 1.2 mg/m² | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ 2.4 mg/m² | 3 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ 4.0 mg/m² | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ 6.0 mg/m² | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ 8.4 mg/m² | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ 11.0 mg/m² | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ 15.0 mg/m² | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ 20.0 mg/m² | 4 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ 27.0 mg/m² | 4 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ 20/27 mg/m² | 4 | 7 |
1 to 10 of 2,915Source ClinicalTrials.gov
See all 2,915 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CFZ 1.2 mg/m² | ||
| Total, all-cause mortality | CFZ 2.4 mg/m² | ||
| Total, all-cause mortality | CFZ 4.0 mg/m² | ||
| Total, all-cause mortality | CFZ 6.0 mg/m² | ||
| Total, all-cause mortality | CFZ 8.4 mg/m² | ||
| Total, all-cause mortality | CFZ 11.0 mg/m² | ||
| Total, all-cause mortality | CFZ 15.0 mg/m² | ||
| Total, all-cause mortality | CFZ 20.0 mg/m² | ||
| Total, all-cause mortality | CFZ 27.0 mg/m² | ||
| Total, all-cause mortality | CFZ 20/27 mg/m² |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00150462
GET https://conductscience.org/api/trials/v1/NCT00150462/results?page=2