A Phase 1/2 interventional study of Bortezomib and Vandetanib in Medullary Thyroid Carcinoma, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-11-29.
Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment
Background:
Objectives:
Eligibility:
Design:
Background:
Objectives:
Eligibility:
Design:
802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.
This study's enrollment of 22 is below the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Phase I: Diagnosis of recurrent, metastatic or primary unresectable solid tumor that does not have curative standard treatment.
Phase II: Diagnosis of recurrent, metastatic or primary unresectable medullary thyroid cancer (MTC).
Organ and marrow function as defined:
EXCLUSION CRITERIA:
The presence of a second malignancy within the last 2 years, other than squamous cell carcinoma of the skin or in situ cervical cancer because it will complicate the primary objective of the study. Cancer survivors who have been free of disease for at least two years can be enrolled in this study.
Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dose
Drug: Bortezomib · Drug: Vandetanib
Patients will be treated with vandetanib alone.
Drug: Vandetanib
Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study
Drug: Bortezomib · Drug: Vandetanib
This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 \& 11 every 28 days in adults
Also known as: Velcade
This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 \& 11 every 28 days in adults
Also known as: Caprelsa
Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Vandetanib
A maximum tolerated dose for vandetanib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.
Time frame: 80 days
Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Bortezomib
A maximum tolerated dose for bortezomib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.
Time frame: 80 days
Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib
Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the 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. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: 4 months
Phase 2: Progression Free Survival in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib
Progression free survival is defined as the duration of time from start of treatment to time of progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Although a clear progression of "non-target" lesions only is exceptional, the opinion of the treating physician should prevail in such circumstances, and the progression status should be confirmed at a later time by the review panel (or Principal Investigator).
Time frame: 4 months
Response Rate (Complete Response (CR) + Partial Response (PR) of Adults With a Diagnosis of MTC Treated With Either of Two Regimens: (1) Daily Oral Vandetanib and Bortezomib or (2) Daily Oral Vandetanib
Comparison of response between cohorts 1, 2A and 2B was to be determined by computed tomography scan reviews using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time frame: 2-3 years
Progression Free Survival (PFS)
Progression free survival is defined as the duration of time from start of treatment to time of progression. Comparison of PFS between cohorts 1, 2A and 2B was to be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is at least a 20% increase in the sum of the 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.
Time frame: 2-3 years
Number of Participants With Adverse Events
Here is the number of participants with adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. For the detailed list of adverse events see the adverse event module.
Time frame: Date treatment consent signed to date off study, approximately 7 years and 9 days
Number of Participants With Tumor Biomarker Calcitonin (CTN) Response
Calcitonin was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CTN level following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CTN level relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CTN relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Stable disease is \<50% increase or decrease in CTN level relative to the baseline level.
Time frame: 4 weeks
Number of Participants With Tumor Biomarker Carcinoembryonic Antigen (CEA) Response
Carcinoembryonic Antigen (CEA) was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CEA level following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CEA level relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CEA relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Stable disease is \<50% increase or decrease in CEA level relative to the baseline level.
Time frame: 4 weeks
Percentage of Participants With a Change in Frequency in Tumor-Related Diarrhea Compared to Baseline
Complete response is an average of 0-2 formed stools per day for a period of at least 4 weeks. partial response is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.
Time frame: Baseline, and for a period of at least 4 weeks post study drug administration
Percentage of Participants With a Change in Consistency in Tumor-Related Diarrhea Compared to Baseline
Baseline stool consistency (formed, loose or partially formed, watery) will be the consistency most frequently observed during a 7-day period immediately prior to starting vandetanib. Complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.
Time frame: Baseline, and for a period of at least 4 weeks post study drug administration
Maximum Bortezomib Plasma Concentration Normalized to Dose (Cmax/D)
Geometric mean for Bortezomib pharmacokinetic (PK) parameters both before (cycle 1 day 1) and during steady-state Vandetanib (cycle 3 day 1; exposures are dose normalized). Bortezomib plasma concentrations were measured using a validated LC-MS/MS assay with a lower limit of quantification (LLOQ) of 1 ng/mL. Only measured concentrations above the LLOQ were used in the calculation of PK parameters. The maximum plasma concentration (Cmax) was recorded as observed values.
Time frame: Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose, 1, 2,4, 6, 8, 10 and 24 hours post dose
Area Under the Bortezomib Plasma Concentration Versus Time Curve From Time Zero to Infinity/Dose (AUCinf/D)
The area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf) was calculated using the linear up-log down trapezoidal method via extrapolation of AUC(LAST) (AUC to the last quantifiable time point) by dividing C(LAST) (the last measurable drug concentration, typically at 24 hour post-dose) by the rate constant of the terminal phase, lambda z. This constant was determined from the slope of the terminal phase of the concentration-time curve using weighted least-squares as the estimation procedure.
Time frame: Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose
Terminal Half-Life (T1/2) of Bortezomib
The time it takes for the measured concentration of the drug to drop by half.
Time frame: Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose
Total Systemic Clearance (CL) of Bortezomib
Total systemic clearance = dose/area under curve extrapolated to infinity (AUCinf.). This measurement represents the rate at which plasma is systematically cleared of drug.
Time frame: Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose
Bortezomib Volume of Distribution (Vss)
Vss represents the volume into which the drug distributes into once given to the patient at steady-state. This volume parameter provides a measure of where in the body the drug is going, based on fluid volume.
Time frame: Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose
Comparison of Steady State Vandetanib Exposure With Relevant Literature Values
Because vandetanib PK exposure was only measured during a single 8-hr window during daily dosing, the only comparison to assess the effect of bortezomib is to compare these values to published literature."
Time frame: Cycle 3 day 1 (an average of 60 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose
| Milestone | Phase 1 - Vandetanib and Bortezomib | Phase 2 A - Vandetanib and Bortezomib at the MTD |
|---|---|---|
| Started | 21 | 1 |
| Completed | 21 | 1 |
| Not completed | 0 | 0 |
A maximum tolerated dose for vandetanib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.
| mg | Phase 1 |
|---|---|
| Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Vandetanib | 300 |
A maximum tolerated dose for bortezomib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.
| mg/m^2 | Phase 1 |
|---|---|
| Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Bortezomib | 1.3 |
Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the 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. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
| Participants | Phase 2 A |
|---|---|
| Complete Response | 0 |
| Partial Response | 0 |
| Stable Disease | 0 |
| Progressive Disease | 1 |
Progression free survival is defined as the duration of time from start of treatment to time of progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Although a clear progression of "non-target" lesions only is exceptional, the opinion of the treating physician should prevail in such circumstances, and the progression status should be confirmed at a later time by the review panel (or Principal Investigator).
| months | Phase 2 A - Vandetanib and Bortezomib at the MTD |
|---|---|
| Phase 2: Progression Free Survival in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib | 3.67 |
Comparison of response between cohorts 1, 2A and 2B was to be determined by computed tomography scan reviews using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
| Participants | Phase 1 | Phase 2A |
|---|---|---|
| Complete Response | 0 | 0 |
| Partial Response | 6 | 0 |
Progression free survival is defined as the duration of time from start of treatment to time of progression. Comparison of PFS between cohorts 1, 2A and 2B was to be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is at least a 20% increase in the sum of the 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.
| Months | Phase 1 | Phase 2A |
|---|---|---|
| Progression Free Survival (PFS) | 30.2 (1.8 to 93.67) | 3.02 |
Here is the number of participants with adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. For the detailed list of adverse events see the adverse event module.
| Participants | Phase 1 | Phase 2 A |
|---|---|---|
| Number of Participants With Adverse Events | 21 | 0 |
Calcitonin was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CTN level following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CTN level relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CTN relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Stable disease is \<50% increase or decrease in CTN level relative to the baseline level.
| Participants | Phase 1 | Phase 2A |
|---|---|---|
| Complete response | 0 | 0 |
| Partial response | 5 | 0 |
| Stable disease | 6 | 0 |
| Progressive disease | 5 | 1 |
| No response | 0 | 0 |
Carcinoembryonic Antigen (CEA) was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CEA level following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CEA level relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CEA relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Stable disease is \<50% increase or decrease in CEA level relative to the baseline level.
| Participants | Phase 1 - Vandetanib and Bortezomib | Phase 2 A |
|---|---|---|
| Complete response | 0 | 0 |
| Partial response | 2 | 0 |
| Stable disease | 9 | 0 |
| Progressive disease | 3 | 1 |
| No response | 0 | 0 |
Complete response is an average of 0-2 formed stools per day for a period of at least 4 weeks. partial response is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.
No measurements were reported for this outcome.
Baseline stool consistency (formed, loose or partially formed, watery) will be the consistency most frequently observed during a 7-day period immediately prior to starting vandetanib. Complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.
No measurements were reported for this outcome.
Geometric mean for Bortezomib pharmacokinetic (PK) parameters both before (cycle 1 day 1) and during steady-state Vandetanib (cycle 3 day 1; exposures are dose normalized). Bortezomib plasma concentrations were measured using a validated LC-MS/MS assay with a lower limit of quantification (LLOQ) of 1 ng/mL. Only measured concentrations above the LLOQ were used in the calculation of PK parameters. The maximum plasma concentration (Cmax) was recorded as observed values.
| ng/mL/mg | Phase 1 - Vandetanib and Bortezomib |
|---|---|
| Before Vandetanib | 0.98 (0.72 to 1.24) |
| After Vandetanib | 1.92 (0.99 to 2.85) |
The area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf) was calculated using the linear up-log down trapezoidal method via extrapolation of AUC(LAST) (AUC to the last quantifiable time point) by dividing C(LAST) (the last measurable drug concentration, typically at 24 hour post-dose) by the rate constant of the terminal phase, lambda z. This constant was determined from the slope of the terminal phase of the concentration-time curve using weighted least-squares as the estimation procedure.
| hr*ng/mL/mg | Phase 1 - Vandetanib and Bortezomib |
|---|---|
| Before Vandetanib | 1.27 (0.57 to 1.97) |
| After Vandetanib | 2.39 (1.67 to 3.11) |
The time it takes for the measured concentration of the drug to drop by half.
| hour | Phase 1 |
|---|---|
| Before Vandetanib | 9.4 (3.5 to 15.4) |
| After Vandetanib | 12.5 (7.3 to 17.7) |
Total systemic clearance = dose/area under curve extrapolated to infinity (AUCinf.). This measurement represents the rate at which plasma is systematically cleared of drug.
| L/hr | Phase 1 |
|---|---|
| Before Vandetanib | 78.7 (37.6 to 120) |
| After Vandetanib | 42.9 (30.4 to 55.4) |
Vss represents the volume into which the drug distributes into once given to the patient at steady-state. This volume parameter provides a measure of where in the body the drug is going, based on fluid volume.
| Liter | Phase 1 |
|---|---|
| Before Vandetanib | 1167 (1049 to 1286) |
| After Vandetanib | 749 (580 to 918) |
Because vandetanib PK exposure was only measured during a single 8-hr window during daily dosing, the only comparison to assess the effect of bortezomib is to compare these values to published literature."
| ng/mL/mg | Phase 1 - Vandetanib and Bortezomib |
|---|---|
| Published Literature | 4.77 ± 1.8 |
| Study 090089 Results | 3.96 ± 0.89 |
Collected over Date treatment consent signed to date off study, approximately 7 years and 9 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1 | 0/21 (0%) | 4/21 (19%) | 21/21 (100%) |
| Phase 2 A | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Event | Phase 1 | Phase 2 A |
|---|---|---|
| Electrocardiogram QT corrected interval prolongedCardiac disorders | 0/21 | 1/1 |
| Lung infectionInfections and infestations | 0/21 | 1/1 |
| Adrenal insufficiencyEndocrine disorders | 1/21 | 0/1 |
| Bronchopulmonary hemorrhageRespiratory, thoracic and mediastinal disorders | 1/21 | 0/1 |
| HypotensionVascular disorders | 1/21 | 0/1 |
| Lymphocyte count decreasedInvestigations | 1/21 | 0/1 |
| Event | Phase 1 | Phase 2 A |
|---|---|---|
| Alanine aminotransferase increasedInvestigations | 20/21 | 1/1 |
| AnemiaBlood and lymphatic system disorders | 9/21 | 1/1 |
| Aspartate aminotransferase increasedInvestigations | 19/21 | 1/1 |
| Back painMusculoskeletal and connective tissue disorders | 5/21 | 1/1 |
| CoughRespiratory, thoracic and mediastinal disorders | 8/21 | 1/1 |
| Creatinine increasedInvestigations | 7/21 | 1/1 |
| Electrocardiogram QT corrected interval prolongedCardiac disorders | 19/21 | 1/1 |
| GGT increasedInvestigations | 4/21 | 1/1 |
| HyponatremiaMetabolism and nutrition disorders | 10/21 | 1/1 |
| Lymphocyte count decreasedInvestigations | 20/21 | 1/1 |
| Age, Categorical(Participants) | Phase 1 | Phase 2 A | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 1 | 17 |
| >=65 years | 5 | 0 | 5 |
| Age, Continuous(years) | Phase 1 | Phase 2 A | Total |
|---|---|---|---|
| Mean | 56.07 ± 10 | 39.8 ± 0 | 55.34 ± 10.58 |
| Sex: Female, Male(Participants) | Phase 1 | Phase 2 A | Total |
|---|---|---|---|
| Female | 8 | 0 | 8 |
| Male | 13 | 1 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1 | Phase 2 A | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 20 | 1 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Phase 1 | Phase 2 A | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 18 | 0 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Phase 1 | Phase 2 A | Total |
|---|---|---|---|
| United States | 21 | 1 | 22 |
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