Trial · NCT00303797
Sorafenib and Bortezomib in Treating Patients With Advanced Cancer
NCT00303797, Phase 1, Terminated, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sorafenib and Bortezomib in Treating Patients With Advanced Cancer. Trials, record NCT00303797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00303797
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sorafenib and Bortezomib in Treating Patients With Advanced Cancer
- NCT number
- NCT00303797
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 14 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult Solid Neoplasm, DS Stage III Multiple Myeloma, Refractory Chronic Lymphocytic Leukemia, Refractory Multiple Myeloma, Stage IV Chronic Lymphocytic Leukemia
- Interventions
- Bortezomib, Sorafenib Tosylate
- First posted
- 2006-03-17
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD as assessed by the number of patients with dose-limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) | Observed for at least 3 weeks at a given dose level combination | DLTs include: Hematologic: Grade 4 ANC for ≥5 days, Grade 4 anemia of any duration, or PLT \<25,000 of any duration; Renal: Serum creatinine ≥2 times baseline or \> 2x upper limit of normal if baseline levels normal; All other non-hematologic toxicities ≥grade 3 as per CTCAE v3.0 except fatigue; Any toxicities that caused dose delay of \> 2 weeks of the intended next dose. MTD is the dose level below the lowest dose that induces DLT in at least one-third of patients (2 of 6 patients). |
| Primary | Toxicity as assessed by CTCAE v3.0 | Observed for at least 3 weeks at a given dose level combination | Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via Common Toxicity Criteria standard grading. Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses. |
| Primary | Antitumor activity as assessed by tumor measurement or evaluation of indicator lesion by computed tomography (CT) or magnetic resonance imaging (MRI) | Baseline, prior to each course (every 3 weeks) during dose escalation, every 6 weeks for solid tumors, and confirmatory scans at least 4 weeks following initial documentation of objective response | |
| Primary | Effects of sorafenib on the disposition of bortezomib | From cohort II registration prior to each course | Up to 20 patients with hematologic malignancies will be treated at the MTD to evaluate markers of drug activity and pharmacokinetics of this combination. |
| Secondary | Tumor response as assessed by CT or MRI using modified Response Evaluation Criteria in Solid Tumors (RECIST) | Baseline, every 3 weeks during dose escalation, every 6 weeks for solid tumors, and confirmatory scans at least 4 weeks following initial documentation of objective response | CLL Modified RECIST: Measurable lesions: lesions that can be accurately measured in at least one dimension with longest diameter \> 20 mm. With spiral CT scan, lesion must be \> 10 mm in at least one dimension. Target lesions (up to 3) should be selected and a sum of the longest diameter (LD) for all will be the baseline sum LD. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum LD. |
| Secondary | Best overall response as assessed using modified RECIST | Baseline until disease progression/recurrence | CLL Progression (PD): As least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Duration of overall response | From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date recurrent or progressive disease is documented | Myeloma CR = Disappearance of M-protein from serum and urine, Bone marrow biopsy ≤5% plasma cells, No increase in lytic bone lesions, and Disappearance of soft tissue plasmacytomas. Patients who meet some, but not all, the criteria are classified as VGPR. Myeloma PR = 50-89% reduction of M-protein in serum and reduction of ≥90% or to \<200 mg in 24-hour urinary light chain excretion (patients with non-secretory myeloma: a ≥50% reduction in plasma cells in a bone marrow aspirate), ≥50% reduction in soft tissue plasmacytoma, and No increase in number or size of lytic bone lesions. |
| Secondary | Duration of stable disease | From the start of the treatment until the criteria for progression are met | Myeloma PD: Increase of M-protein \>25% above the lowest response level in serum or urine (absolute increase of at least 0.5 g/dL serum or 200 mg/24 hours urine); Patients with non-secretory myeloma: an increase in bone marrow plasmacytosis by 25% above the lowest remission value (absolute increase at least 10% bone marrow plasma cells); New soft tissue plasmacytomas or increase in size by 50% (and at least 1 cm); New lytic bone lesions or increase in the size of the existing bone lesions by 50% (and at least 1 cm); Development of hypercalcemia serum calcium \>11.5 mg/dL. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23887852 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01CA069912 | Phase I Clinical Trials of Anticancer Agents | ERLICHMAN, CHARLES | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1995 to 2013 |
Source NIH RePORTER
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/NCT00303797
GET https://conductscience.org/api/trials/v1/NCT00303797/registered