Trial · NCT00618982
Sorafenib Dose Escalation in Renal Cell Carcinoma
NCT00618982, Phase 2, Completed, Bayer; results first posted 2010-05-27
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ConductScience Library. Sorafenib Dose Escalation in Renal Cell Carcinoma. Trials, record NCT00618982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00618982
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sorafenib Dose Escalation in Renal Cell Carcinoma
- NCT number
- NCT00618982
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Carcinoma, Renal Cell
- Interventions
- Sorafenib (Nexavar, BAY43-9006)
- First posted
- 2008-02-20
- Last updated
- 2015-12-24
- Other registries' IDs
- eudract:2007-004875-21
- Results first posted
- 2010-05-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Response - mITT (Modified Intent-to-treat) Population | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | Best Response (Response Rate) of a subject was defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor and PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes. |
| Primary | Tumor Response - ITT (Intent to Treat) Population | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions. |
| Secondary | Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss) | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose. | AUC(0-10),ss was defined as an area under the plasma concentration versus time curve from time zero to 10 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. |
| Secondary | Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss) | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. | AUC(0-12),ss was defined as an area under the plasma concentration versus time curve from time zero to 12 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. |
| Secondary | Pharmacokinetics (PK) Analysis - Maximum Observed Concentration in Plasma (Cmax) | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. | Cmax was defined as a maximum plasma concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. |
| Secondary | Pharmacokinetics (PK) Analysis - Time to Maximum Concentration (Tmax) | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. | Tmax was defined as a time to maximum concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. |
| Secondary | Progression-free Survival (PFS) | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | Progression-free survival (PFS) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment or death due to any cause whichever occurred first. For patients who had not recurred or died at the time of analysis, PFS was censored at their last date of evaluable scan. |
| Secondary | Time to Progression (TTP) | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | Time to progression (TTP) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment whichever occurred first. For patients who had not progressed at the time of analysis or died before progression, TTP was censored at their last date of evaluable scan. |
| Other | Tumor Response - mITT Population | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions. |
| Other | Disease Control - mITT Population | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | Disease Control (DC) of a subject was defined as the proportion of patients with confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, and SD was defined as steady state of disease. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Response - mITT (Modified Intent-to-treat) Population | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose. | Participants | NUMBER |
| PRIMARY | Tumor Response - ITT (Intent to Treat) Population | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | The population for the efficacy analysis was the intent-to-treat (ITT) population defined as all patients who received at least one dose of study medication with at least one valid tumor assessment post-baseline. | participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss) | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose. | PK Analysis Population. 40 participants in the 400 mg bid group that had an AUC(0-10)ss calculated; 30 participants in the 600 mg bid group that had an AUC(0-10)ss calculated; 26 participants and 27 participants in the 800 mg bid group that had an AUC(0-10)ss calculated, for sorafenib and M2 parameter respectively. | mg*h/L | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss) | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. | PK Analysis Population. 32 participants in the 400 mg bid group that had an AUC(0-12)ss calculated; 23 participants in the 600 mg bid group that had an AUC(0-12)ss calculated; 19 participants and 20 participants in the 800 mg bid group that had an AUC(0-12)ss calculated, for sorafenib and M2 parameter respectively. | mg*h/L | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK) Analysis - Maximum Observed Concentration in Plasma (Cmax) | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. | PK Analysis Population. 40 participants in the 400 mg bid group that had Cmax calculated; 31 participants in the 600 mg bid group that had Cmax calculated; 28 participants in the 800 mg bid group that had Cmax calculated. | mg/L | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK) Analysis - Time to Maximum Concentration (Tmax) | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. | PK Analysis Population. 40 participants in the 400 mg bid group that had Tmax calculated; 31 participants in the 600 mg bid group that had Tmax calculated; 28 participants in the 800 mg bid group that had Tmax calculated. | hours | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | Intent-to-treat (ITT). | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | Intent-to treat (ITT). | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Tumor Response - mITT Population | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Disease Control - mITT Population | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. | The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Response - mITT (Modified Intent-to-treat) Population | Sorafenib (Nexavar, BAY43-9006) | 8 | 21.5 to 69.2 | Participants | |
| Tumor Response - ITT (Intent to Treat) Population | Sorafenib (Nexavar, BAY43-9006) | Complete Response (CR) | 0 | participants | |
| Tumor Response - ITT (Intent to Treat) Population | Sorafenib (Nexavar, BAY43-9006) | Partial Response (PR) | 12 | participants | |
| Tumor Response - ITT (Intent to Treat) Population | Sorafenib (Nexavar, BAY43-9006) | Stable Disease (SD) | 46 | participants | |
| Tumor Response - ITT (Intent to Treat) Population | Sorafenib (Nexavar, BAY43-9006) | Progressive Disease (PD) | 9 | participants | |
| Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss) | Sorafenib (Nexavar, BAY43-9006)_400 mg | Sorafenib (N=40, 30, 26) | 50.0 | Geometric Coefficient of Variation 39.2 | mg*h/L |
| Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss) | Sorafenib (Nexavar, BAY43-9006)_600 mg | Sorafenib (N=40, 30, 26) | 51.2 | Geometric Coefficient of Variation 43.7 | mg*h/L |
| Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss) | Sorafenib (Nexavar, BAY43-9006)_800 mg | Sorafenib (N=40, 30, 26) | 43.8 | Geometric Coefficient of Variation 47.8 | mg*h/L |
| Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss) | Sorafenib (Nexavar, BAY43-9006)_400 mg | M2 (BAY67-3472) (N=40, 30, 27) | 8.80 | Geometric Coefficient of Variation 74.3 | mg*h/L |
| Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss) | Sorafenib (Nexavar, BAY43-9006)_600 mg | M2 (BAY67-3472) (N=40, 30, 27) | 10.4 | Geometric Coefficient of Variation 82.1 | mg*h/L |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sorafenib (Nexavar, BAY43-9006) | 83 | |
| Overall Study | COMPLETED | Sorafenib (Nexavar, BAY43-9006) | 33 | |
| Overall Study | NOT COMPLETED | Sorafenib (Nexavar, BAY43-9006) | 50 |
Source ClinicalTrials.gov
Adverse events137
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 | Edema: Limb | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) | 7 | 83 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) | 12 | 83 | |
| other | Neutrophils | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) | 3 | 83 | |
| other | Platelets | Blood and lymphatic system disorders | Sorafenib (Nexavar, BAY43-9006) | 7 | 83 | |
| other | Hypertension | Cardiac disorders | Sorafenib (Nexavar, BAY43-9006) | 40 | 83 | |
| other | Hypotension | Cardiac disorders | Sorafenib (Nexavar, BAY43-9006) | 3 | 83 | |
| other | Hyperthyroidism | Endocrine disorders | Sorafenib (Nexavar, BAY43-9006) | 3 | 83 | |
| other | Hypothyroidism | Endocrine disorders | Sorafenib (Nexavar, BAY43-9006) | 12 | 83 | |
| other | Dry eye | Eye disorders | Sorafenib (Nexavar, BAY43-9006) | 3 | 83 | |
| other | Ocular - Other | Eye disorders | Sorafenib (Nexavar, BAY43-9006) | 3 | 83 |
1 to 10 of 137Source ClinicalTrials.gov
See all 137 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sorafenib (Nexavar, BAY43-9006) | ||
| Total, other adverse events | Sorafenib (Nexavar, BAY43-9006) | 80 | 83 |
| Total, serious adverse events | Sorafenib (Nexavar, BAY43-9006) | 45 | 83 |
Source ClinicalTrials.gov
Papers0
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/NCT00618982
GET https://conductscience.org/api/trials/v1/NCT00618982/results?page=2