Trial · NCT00531284
Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma
NCT00531284, Phase 1, Phase 2, Completed, Amgen; results first posted 2015-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma. Trials, record NCT00531284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00531284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma
- NCT number
- NCT00531284
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 184 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Ovarian Cancer, Renal Cancer, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Solid Tumors, Multiple Myeloma, Lymphoma
- Interventions
- Carfilzomib, Dexamethasone
- First posted
- 2007-09-18
- Last updated
- 2017-08-15
- Results first posted
- 2015-12-09
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | 28 days | Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0. A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding. The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which \< 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle. |
| Primary | Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles | 4 months | Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target and non-target lesions and no new lesions; PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions. |
| Secondary | Percentage of Participants With an Overall Response Throughout the Study | Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months. | Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM. Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR. |
| Secondary | Duration of Response | Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months. | Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored. |
| Secondary | Progression-Free Survival | Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months. | Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first. |
| Secondary | Time to Progression | Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months. | Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression. |
| Secondary | Maximum Observed Plasma Concentration of Carfilzomib | Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion. | Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses. |
| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib | Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion. | |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib | Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion. | |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib | Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | 28 days | Dose-limiting toxicity analysis was based on subsets of the safety population including participants exposed to carfilzomib in Cycle 1 who experienced a DLT or completed 28 days of evaluation after the first dose of carfilzomib. Participants enrolled into the expansion cohorts (MTD dose expansion, carfilzomib + DEX) were not evaluated for DLT. | participants | NUMBER |
| PRIMARY | Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles | 4 months | Phase 2 Safety population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Overall Response Throughout the Study | Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months. | Safety Population | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months. | Safety Population with a partial response or better | months | MEDIAN |
| SECONDARY | Progression-Free Survival | Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months. | Safety population | months | MEDIAN |
| SECONDARY | Time to Progression | Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months. | Safety population. | months | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration of Carfilzomib | Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion. | Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone). | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib | Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion. | Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone). | hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib | Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion. | Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone). | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib | Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion. | Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone). | h*ng/mL | GEOMETRIC_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group121
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B ST: CFZ 20 mg/m² Bolus | 0 | participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B ST: CFZ 20/27 mg/m² Bolus | 0 | participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B ST: CFZ 20/36 mg/m² Bolus | 1 | participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B ST: CFZ 36 mg/m² | 0 | participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B ST: CFZ 45 mg/m² | 2 | participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B ST: CFZ 20/45 mg/m² | 0 | participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B ST: CFZ 20/56 mg/m² | 0 | participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B ST: CFZ 20/70 mg/m² | 1 | participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B MM: CFZ 20/36 mg/m² | 0 | participants | ||
| Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT) | P1B MM: CFZ 20/45 mg/m² | 0 | participants |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 results by groupParticipant flow51
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | P1B ST: CFZ 20 mg/m² Bolus | 3 | |
| Overall Study | STARTED | P1B ST: CFZ 20/27 mg/m² Bolus | 4 | |
| Overall Study | STARTED | P1B ST: CFZ 20/36 mg/m² Bolus | 7 | |
| Overall Study | STARTED | P2 ST: CFZ 20/36 mg/m² Bolus | 65 | |
| Overall Study | STARTED | P1B ST: CFZ 36 mg/m² | 6 | |
| Overall Study | STARTED | P1B ST: CFZ 45 mg/m² | 7 | |
| Overall Study | STARTED | P1B ST: CFZ 20/45 mg/m² | 6 | |
| Overall Study | STARTED | P1B ST: CFZ 20/56 mg/m² | 10 | |
| Overall Study | STARTED | P1B ST: CFZ 20/70 mg/m² | 11 | |
| Overall Study | STARTED | P1B MM: CFZ 20/36 mg/m² | 4 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 participant flowAdverse events6,834
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 | P1B ST: CFZ 20 mg/m² Bolus | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | P1B ST: CFZ 20/27 mg/m² Bolus | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | P1B ST: CFZ 20/36 mg/m² Bolus | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | P2 ST: CFZ 20/36 mg/m² Bolus | 17 | 65 | |
| other | Anaemia | Blood and lymphatic system disorders | P1B ST: CFZ 36 mg/m² | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | P1B ST: CFZ 45 mg/m² | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | P1B ST: CFZ 20/45 mg/m² | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | P1B ST: CFZ 20/56 mg/m² | 4 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | P1B ST: CFZ 20/70 mg/m² | 3 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | P1B MM: CFZ 20/36 mg/m² | 2 | 4 |
1 to 10 of 6,834Source ClinicalTrials.gov
See all 6,834 adverse eventsAdverse event totals51
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | P1B ST: CFZ 20 mg/m² Bolus | ||
| Total, all-cause mortality | P1B ST: CFZ 20/27 mg/m² Bolus | ||
| Total, all-cause mortality | P1B ST: CFZ 20/36 mg/m² Bolus | ||
| Total, all-cause mortality | P2 ST: CFZ 20/36 mg/m² Bolus | ||
| Total, all-cause mortality | P1B ST: CFZ 36 mg/m² | ||
| Total, all-cause mortality | P1B ST: CFZ 45 mg/m² | ||
| Total, all-cause mortality | P1B ST: CFZ 20/45 mg/m² | ||
| Total, all-cause mortality | P1B ST: CFZ 20/56 mg/m² | ||
| Total, all-cause mortality | P1B ST: CFZ 20/70 mg/m² | ||
| Total, all-cause mortality | P1B MM: CFZ 20/36 mg/m² |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00531284
GET https://conductscience.org/api/trials/v1/NCT00531284/results?page=2