Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Participants With Advanced or Metastatic Cancer
Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00408434
Collaborator
(none)
32
2
1
39
16
0.4
Study Details
Study Description
Brief Summary
An open-label, Phase I, dose escalation study of CS-7017 administered by mouth in sequential cohorts of 3 to 6 participants with advanced or metastatic malignancies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Dose Finding Study of an Experimental New Drug, PPARγ Agonist Taken by Mouth by Patients With Advanced or Malignancies
Study Start Date
:
Nov 1, 2006
Actual Primary Completion Date
:
Feb 1, 2010
Actual Study Completion Date
:
Feb 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CS-7017 CS-7017 from 0.05 to 3.2 mg bid |
Drug: CS-7017
CS-7017 0.05mg and 1.0mg tablets
|
Outcome Measures
Primary Outcome Measures
- Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies [Baseline up to at least 2 cycles (each cycle was 3 weeks), up to 2 years 5 months]
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions). Objective response rate was defined as the sum of all CRs and PRs.
Secondary Outcome Measures
- Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies [Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.]
Area under the plasma/serum drug concentration-time curve for dosing interval (AUC[0-tau]), computed using the linear trapezoidal rule and area under the plasma/serum drug concentration-time curve from 0 to last time point above the quantification limit (AUC[0-t]) calculated using the linear trapezoidal rule were assessed.
- Summary of Pharmacokinetic Parameter Observed Maximum Plasma Concentration (Cmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies [Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.]
Cmax was defined as observed maximum plasma concentration.
- Summary of Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies [Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.]
- Summary of Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies [Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1.]
Tmax was defined as time of maximum plasma concentration.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically or cytologically diagnosed advanced or metastatic malignancy that is refractory to, not curable with, or not eligible for standard treatment(s).
-
18 years or older
-
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
-
Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 grade less than or equal to 1.
-
Adequate organ and bone marrow function.
-
Willing to use effective contraceptive while on treatment through at least 3 months thereafter.
-
Negative pregnancy test for females of childbearing potential.
-
Echocardiogram with ejection fraction within normal range.
Exclusion Criteria:
-
Anticipation of need for a major surgical procedure or radiation therapy during the study.
-
Treatment with chemotherapy, hormonal therapy, other thiazolidinediones, radiotherapy, minor surgery, or any investigational agent within 4 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery) of study treatment start.
-
Participants with clinically significant pleural or pericardial effusion (participants with minimal pleural effusion may be eligible at the Investigator's discretion).
-
Clinically significant active infection, which requires antibiotic therapy, or human immunodeficiency virus (HIV)-positive participants receiving antiretroviral therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington | District of Columbia | United States | ||
| 2 | Boston | Massachusetts | United States |
Sponsors and Collaborators
- Daiichi Sankyo, Inc.
Investigators
- Study Director: Study Clinical Lead, Daiichi Sankyo, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT00408434
Other Study ID Numbers:
- CS7017-A-U102
First Posted:
Dec 7, 2006
Last Update Posted:
Oct 19, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Daiichi Sankyo, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 32 participants who met all inclusion criteria and no exclusion criteria were enrolled in study from 20 November 2006 to 03 April 2009 at 2 clinic sites in the United States. Of the 32 participants enrolled, 31 participants were dosed and received treatment. |
|---|---|
| Pre-assignment Detail | Participants received CS-7017 (0.10 mg to 1.15 mg) every 12 hours. At least 3 participants were treated at each dose level. Dose escalation occurred after at least 3 participants in the current dosing cohort completed 1 cycle of treatment (3 weeks). |
| Arm/Group Title | CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who received oral CS-7017 0.10 mg every 12 hours. | Participants who received oral CS-7017 0.15 mg every 12 hours. | Participants who received oral CS-7017 0.25 mg every 12 hours. | Participants who received oral CS-7017 0.35 mg every 12 hours. | Participants who received oral CS-7017 0.50 mg every 12 hours. | Participants who received oral CS-7017 0.75 mg every 12 hours. | Participants who received oral CS-7017 1.15 mg every 12 hours. |
| Period Title: Overall Study | |||||||
| STARTED | 6 | 3 | 6 | 3 | 6 | 3 | 4 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 6 | 3 | 6 | 3 | 6 | 3 | 4 |
Baseline Characteristics
| Arm/Group Title | CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who received oral CS-7017 0.10 mg every 12 hours. | Participants who received oral CS-7017 0.15 mg every 12 hours. | Participants who received oral CS-7017 0.25 mg every 12 hours. | Participants who received oral CS-7017 0.35 mg every 12 hours. | Participants who received oral CS-7017 0.50 mg every 12 hours. | Participants who received oral CS-7017 0.75 mg every 12 hours. | Participants who received oral CS-7017 1.15 mg every 12 hours. | Total of all reporting groups |
| Overall Participants | 6 | 3 | 6 | 3 | 6 | 3 | 4 | 31 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
59.7
(8.2)
|
57.0
(14.7)
|
58.7
(8.8)
|
58.7
(13.7)
|
62.3
(8.6)
|
52.3
(11.1)
|
53.5
(7.6)
|
58.1
(9.4)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
3
50%
|
0
0%
|
4
66.7%
|
0
0%
|
2
33.3%
|
0
0%
|
0
0%
|
9
29%
|
| Male |
3
50%
|
3
100%
|
2
33.3%
|
3
100%
|
4
66.7%
|
3
100%
|
4
100%
|
22
71%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
2
66.7%
|
0
0%
|
0
0%
|
0
0%
|
2
6.5%
|
| Not Hispanic or Latino |
6
100%
|
3
100%
|
6
100%
|
1
33.3%
|
6
100%
|
3
100%
|
4
100%
|
29
93.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||||||
| United States |
6
100%
|
3
100%
|
6
100%
|
3
100%
|
6
100%
|
3
100%
|
4
100%
|
31
100%
|
Outcome Measures
| Title | Best Overall Tumor Response Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies |
|---|---|
| Description | Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions). Objective response rate was defined as the sum of all CRs and PRs. |
| Time Frame | Baseline up to at least 2 cycles (each cycle was 3 weeks), up to 2 years 5 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Best overall response was assessed in the Efficacy Population. |
| Arm/Group Title | CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg | CS-7017 All Participants |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who received oral CS-7017 0.10 mg every 12 hours. | Participants who received oral CS-7017 0.15 mg every 12 hours. | Participants who received oral CS-7017 0.25 mg every 12 hours. | Participants who received oral CS-7017 0.35 mg every 12 hours. | Participants who received oral CS-7017 0.50 mg every 12 hours. | Participants who received oral CS-7017 0.75 mg every 12 hours. | Participants who received oral CS-7017 1.15 mg every 12 hours. | All participants who received CS-7017 with doses ranging from 0.10 mg to 1.15 mg every 12 hours. |
| Measure Participants | 6 | 3 | 4 | 3 | 5 | 3 | 3 | 27 |
| Complete response (CR) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Partial response (PR) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
1
3.2%
|
| Stable disease (SD) |
3
50%
|
2
66.7%
|
0
0%
|
1
33.3%
|
4
66.7%
|
1
33.3%
|
1
25%
|
12
38.7%
|
| Progressive disease (PD) |
3
50%
|
1
33.3%
|
4
66.7%
|
2
66.7%
|
1
16.7%
|
1
33.3%
|
2
50%
|
14
45.2%
|
| Objective response rate (CR+PR) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
1
3.2%
|
| Title | Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Participants With Advanced or Metastatic Malignancies |
|---|---|
| Description | Area under the plasma/serum drug concentration-time curve for dosing interval (AUC[0-tau]), computed using the linear trapezoidal rule and area under the plasma/serum drug concentration-time curve from 0 to last time point above the quantification limit (AUC[0-t]) calculated using the linear trapezoidal rule were assessed. |
| Time Frame | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameters were assessed in the Pharmacokinetic Population. |
| Arm/Group Title | CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who received oral CS-7017 0.10 mg every 12 hours. | Participants who received oral CS-7017 0.15 mg every 12 hours. | Participants who received oral CS-7017 0.25 mg every 12 hours. | Participants who received oral CS-7017 0.35 mg every 12 hours. | Participants who received oral CS-7017 0.50 mg every 12 hours. | Participants who received oral CS-7017 0.75 mg every 12 hours. | Participants who received oral CS-7017 1.15 mg every 12 hours. |
| Measure Participants | 6 | 3 | 6 | 3 | 6 | 3 | 4 |
| AUC(0-tau) |
23.05
(6.11)
|
32.05
(7.75)
|
68.33
(24.61)
|
59.72
(32.58)
|
159.2
(45.10)
|
159.14
(126.31)
|
256.3
(93.31)
|
| AUC(0-12) |
32.96
(6.90)
|
44.14
(12.15)
|
91.24
(36.16)
|
80.80
(40.74)
|
220.9
(74.42)
|
214.38
(163.81)
|
356.8
(127.69)
|
| Title | Summary of Pharmacokinetic Parameter Observed Maximum Plasma Concentration (Cmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies |
|---|---|
| Description | Cmax was defined as observed maximum plasma concentration. |
| Time Frame | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameters were assessed in the Pharmacokinetic Population. |
| Arm/Group Title | CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who received oral CS-7017 0.10 mg every 12 hours. | Participants who received oral CS-7017 0.15 mg every 12 hours. | Participants who received oral CS-7017 0.25 mg every 12 hours. | Participants who received oral CS-7017 0.35 mg every 12 hours. | Participants who received oral CS-7017 0.50 mg every 12 hours. | Participants who received oral CS-7017 0.75 mg every 12 hours. | Participants who received oral CS-7017 1.15 mg every 12 hours. |
| Measure Participants | 6 | 3 | 6 | 3 | 6 | 3 | 4 |
| Mean (Standard Deviation) [ng/ml] |
4.21
(0.93)
|
5.76
(1.53)
|
12.19
(3.00)
|
12.26
(7.10)
|
26.92
(6.36)
|
27.64
(21.44)
|
44.73
(15.05)
|
| Title | Summary of Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies |
|---|---|
| Description | |
| Time Frame | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameters were assessed in the Pharmacokinetic Population. |
| Arm/Group Title | CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who received oral CS-7017 0.10 mg every 12 hours. | Participants who received oral CS-7017 0.15 mg every 12 hours. | Participants who received oral CS-7017 0.25 mg every 12 hours. | Participants who received oral CS-7017 0.35 mg every 12 hours. | Participants who received oral CS-7017 0.50 mg every 12 hours. | Participants who received oral CS-7017 0.75 mg every 12 hours. | Participants who received oral CS-7017 1.15 mg every 12 hours. |
| Measure Participants | 6 | 3 | 6 | 3 | 6 | 3 | 4 |
| Mean (Standard Deviation) [hour] |
8.51
(3.92)
|
13.78
(6.92)
|
11.48
(11.30)
|
12.49
(7.35)
|
5.74
(2.56)
|
9.08
(2.79)
|
11.66
(3.45)
|
| Title | Summary of Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Means of Serum Free Form of CS-7017 (R-150033) Following Administration of CS-7017 in Patients With Advanced or Metastatic Malignancies |
|---|---|
| Description | Tmax was defined as time of maximum plasma concentration. |
| Time Frame | Day 1 of Cycles 1 and 2: predose, 0.5, 1, 2, 3, 4, 6, and 10 hours postdose; and predose on Day 8 and 15 of Cycle 1. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic parameters were assessed in the Pharmacokinetic Population. |
| Arm/Group Title | CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who received oral CS-7017 0.10 mg every 12 hours. | Participants who received oral CS-7017 0.15 mg every 12 hours. | Participants who received oral CS-7017 0.25 mg every 12 hours. | Participants who received oral CS-7017 0.35 mg every 12 hours. | Participants who received oral CS-7017 0.50 mg every 12 hours. | Participants who received oral CS-7017 0.75 mg every 12 hours. | Participants who received oral CS-7017 1.15 mg every 12 hours. |
| Measure Participants | 6 | 3 | 6 | 3 | 6 | 3 | 4 |
| Mean (Full Range) [hour] |
3.00
|
2.00
|
1.58
|
3.00
|
2.00
|
3.00
|
2.50
|
Adverse Events
| Time Frame | Treatment-emergent adverse events (TEAEs) data were collected from baseline up to 30 days after the last dose of study drug, up to 2 years 5 months. | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose. | |||||||||||||
| Arm/Group Title | CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg | |||||||
| Arm/Group Description | Participants who received oral CS-7017 0.10 mg every 12 hours. | Participants who received oral CS-7017 0.15 mg every 12 hours. | Participants who received oral CS-7017 0.25 mg every 12 hours. | Participants who received oral CS-7017 0.35 mg every 12 hours. | Participants who received oral CS-7017 0.50 mg every 12 hours. | Participants who received oral CS-7017 0.75 mg every 12 hours. | Participants who received oral CS-7017 1.15 mg every 12 hours. | |||||||
All Cause Mortality |
||||||||||||||
| CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 2/3 (66.7%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/6 (50%) | 0/3 (0%) | 2/6 (33.3%) | 2/3 (66.7%) | 3/6 (50%) | 0/3 (0%) | 1/4 (25%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Anaemia | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Cardiac disorders | ||||||||||||||
| Cardiac failure congestive | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| General disorders | ||||||||||||||
| Chest pain | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Pneumonia | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Urinary tract infection | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Seroma | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 1/4 (25%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Dehydration | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Fluid overloading | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Malnutrition | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Back pain | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Musculoskeletal pain | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Neck pain | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Brain cancer metastatic | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Liposarcoma recurrent | 0/6 (0%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Spinal cord compression | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Syncope | 0/6 (0%) | 0/3 (0%) | 1/6 (16.7%) | 1/3 (33.3%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Haematuria | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Urinary tract obstruction | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Bronchospasm | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Pleural effusion | 0/6 (0%) | 0/3 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| CS-7017 0.10 mg | CS-7017 0.15 mg | CS-7017 0.25 mg | CS-7017 0.35 mg | CS-7017 0.50 mg | CS-7017 0.75 mg | CS-7017 1.15 mg | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 3/3 (100%) | 6/6 (100%) | 3/3 (100%) | 6/6 (100%) | 3/3 (100%) | 4/4 (100%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Anaemia | 4/6 (66.7%) | 2/3 (66.7%) | 6/6 (100%) | 1/3 (33.3%) | 1/6 (16.7%) | 2/3 (66.7%) | 1/4 (25%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal pain | 2/6 (33.3%) | 0/3 (0%) | 1/6 (16.7%) | 1/3 (33.3%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Diarrhoea | 1/6 (16.7%) | 1/3 (33.3%) | 0/6 (0%) | 1/3 (33.3%) | 1/6 (16.7%) | 1/3 (33.3%) | 0/4 (0%) | |||||||
| Nausea | 2/6 (33.3%) | 1/3 (33.3%) | 0/6 (0%) | 1/3 (33.3%) | 4/6 (66.7%) | 0/3 (0%) | 1/4 (25%) | |||||||
| Vomiting | 1/6 (16.7%) | 1/3 (33.3%) | 0/6 (0%) | 1/3 (33.3%) | 4/6 (66.7%) | 0/3 (0%) | 0/4 (0%) | |||||||
| General disorders | ||||||||||||||
| Fatigue | 2/6 (33.3%) | 1/3 (33.3%) | 3/6 (50%) | 1/3 (33.3%) | 6/6 (100%) | 2/3 (66.7%) | 4/4 (100%) | |||||||
| Oedema peripheral | 6/6 (100%) | 1/3 (33.3%) | 3/6 (50%) | 1/3 (33.3%) | 3/6 (50%) | 2/3 (66.7%) | 1/4 (25%) | |||||||
| Investigations | ||||||||||||||
| Weight increased | 5/6 (83.3%) | 2/3 (66.7%) | 4/6 (66.7%) | 1/3 (33.3%) | 1/6 (16.7%) | 1/3 (33.3%) | 3/4 (75%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Anorexia | 1/6 (16.7%) | 1/3 (33.3%) | 0/6 (0%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | 1/4 (25%) | |||||||
| Dehydration | 1/6 (16.7%) | 1/3 (33.3%) | 1/6 (16.7%) | 1/3 (33.3%) | 2/6 (33.3%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Back pain | 1/6 (16.7%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | 2/6 (33.3%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Muscle spasms | 1/6 (16.7%) | 1/3 (33.3%) | 0/6 (0%) | 1/3 (33.3%) | 0/6 (0%) | 0/3 (0%) | 1/4 (25%) | |||||||
| Musculoskeletal pain | 2/6 (33.3%) | 0/3 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 2/4 (50%) | |||||||
| Nervous system disorders | ||||||||||||||
| Dizziness | 1/6 (16.7%) | 2/3 (66.7%) | 0/6 (0%) | 1/3 (33.3%) | 2/6 (33.3%) | 0/3 (0%) | 0/4 (0%) | |||||||
| Headache | 1/6 (16.7%) | 0/3 (0%) | 0/6 (0%) | 0/3 (0%) | 1/6 (16.7%) | 2/3 (66.7%) | 0/4 (0%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Cough | 1/6 (16.7%) | 1/3 (33.3%) | 2/6 (33.3%) | 0/3 (0%) | 3/6 (50%) | 2/3 (66.7%) | 1/4 (25%) | |||||||
| Dyspnoea | 2/6 (33.3%) | 0/3 (0%) | 2/6 (33.3%) | 1/3 (33.3%) | 2/6 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | |||||||
| Pleural effusion | 1/6 (16.7%) | 0/3 (0%) | 1/6 (16.7%) | 1/3 (33.3%) | 0/6 (0%) | 0/3 (0%) | 1/4 (25%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Contact for Clinical Trial Information |
|---|---|
| Organization | Daiichi Sankyo |
| Phone | 908-992-6400 |
| CTRinfo@dsi.com |
Responsible Party:
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT00408434
Other Study ID Numbers:
- CS7017-A-U102
First Posted:
Dec 7, 2006
Last Update Posted:
Oct 19, 2020
Last Verified:
Sep 1, 2020