Trial Outcomes & Findings for A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin (NCT NCT01182285)
NCT ID: NCT01182285
Last Updated: 2018-05-16
Results Overview
Complete response (CR) is increased Rai uptake on post- valproic acid therapy at week 10, AND a decrease in Tg level to less than 2 ng/ml (or a decrease in Tg-Ab level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Entry to study and after 10 weeks of treatment for Phase 1, and 10 weeks of treatment to 16 weeks of treatment for phase 2.
Results posted on
2018-05-16
Participant Flow
Five and eight participants were enrolled from University of California San Francisco (UCSF) and the National Institutes of Health (NIH), respectively.
Participant milestones
| Measure |
A - Phase 1 Radioiodine Resistant Thyroid Cancer
Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
|
B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)
Drug: Valproic Acid Week 11 - 17 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Drug: Cytomel (25 micrograms) Patients who exhibit an increased radioiodine uptake on Thyrogen scan post valproic acid therapy at week 10. Begin Liothyronine Sodium (Cytomel) for 4 weeks (25 micrograms twice a day)
|
B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)
Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
|
|---|---|---|---|
|
First Intervention Week 1-10
STARTED
|
13
|
0
|
0
|
|
First Intervention Week 1-10
COMPLETED
|
10
|
0
|
0
|
|
First Intervention Week 1-10
NOT COMPLETED
|
3
|
0
|
0
|
|
Second Intervention Week 11-17
STARTED
|
0
|
0
|
0
|
|
Second Intervention Week 11-17
COMPLETED
|
0
|
0
|
0
|
|
Second Intervention Week 11-17
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention Week 11-52
STARTED
|
0
|
0
|
8
|
|
Third Intervention Week 11-52
COMPLETED
|
0
|
0
|
0
|
|
Third Intervention Week 11-52
NOT COMPLETED
|
0
|
0
|
8
|
Reasons for withdrawal
| Measure |
A - Phase 1 Radioiodine Resistant Thyroid Cancer
Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
|
B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)
Drug: Valproic Acid Week 11 - 17 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Drug: Cytomel (25 micrograms) Patients who exhibit an increased radioiodine uptake on Thyrogen scan post valproic acid therapy at week 10. Begin Liothyronine Sodium (Cytomel) for 4 weeks (25 micrograms twice a day)
|
B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)
Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
|
|---|---|---|---|
|
First Intervention Week 1-10
Disease progression
|
1
|
0
|
0
|
|
First Intervention Week 1-10
Adverse Event
|
1
|
0
|
0
|
|
First Intervention Week 1-10
Non-compliance
|
1
|
0
|
0
|
|
Third Intervention Week 11-52
Disease Progression
|
0
|
0
|
6
|
|
Third Intervention Week 11-52
Other
|
0
|
0
|
2
|
Baseline Characteristics
A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin
Baseline characteristics by cohort
| Measure |
All Participants (Phase 1 and Phase 2 Schedule 2)
n=13 Participants
A- Phase 1 Radioiodine-Resistant Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
B2 - Phase 2 Schedule 2 Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
|
|---|---|
|
Age, Continuous
|
61.08 years
STANDARD_DEVIATION 7.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Entry to study and after 10 weeks of treatment for Phase 1, and 10 weeks of treatment to 16 weeks of treatment for phase 2.Population: 13 participants were enrolled in phase 1 and 8/13 (5 from University of California San Francisco (UCSF) moved on from phase 1 to the phase 2 schedule 2 portion. However, Tg data from UCSF is unavailable for 5 of the participant, thus only 3 were analyzed in the phase 2 portion.
Complete response (CR) is increased Rai uptake on post- valproic acid therapy at week 10, AND a decrease in Tg level to less than 2 ng/ml (or a decrease in Tg-Ab level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.
Outcome measures
| Measure |
A - Phase 1 Radioiodine Resistant Thyroid Cancer
n=13 Participants
Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
|
B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)
n=3 Participants
Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
|
|---|---|---|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 480 ng/ml
|
1 Participants
|
1 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
anti Tg end - 220 IU/ml
|
0 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
antiTg end - 80 IU/ml
|
0 Participants
|
1 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - >900 ng/ml
|
6 Participants
|
1 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - 707 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - 661 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - 362 ng/ml
|
0 Participants
|
1 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - 289 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - 183 ng/ml
|
0 Participants
|
1 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - 154 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - 101 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - 99 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg start - 15.7 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
antiTg start - 142 IU/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
antiTg start - 220 IU/ml
|
0 Participants
|
1 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
antiTg start - <20 IU/ml
|
7 Participants
|
2 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - >900 ng/ml
|
4 Participants
|
1 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 749 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 702 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 630 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 362 ng/ml
|
0 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 204 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 184 ng/ml
|
0 Participants
|
1 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 183 ng/ml
|
0 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 128 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 61 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - 10.8 ng/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
Tg end - none
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
antiTg end - 338 IU/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
antiTg end - 83 IU/ml
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
anti Tg end - <20 IU/ml
|
5 Participants
|
2 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
antiTg end - none
|
1 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
RAI uptake pre-treatment - none
|
13 Participants
|
0 Participants
|
|
RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment
RAI uptake post treatment - none
|
10 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 41 months and 11 daysPopulation: Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study.
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
A - Phase 1 Radioiodine Resistant Thyroid Cancer
n=13 Participants
Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
|
B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)
Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Best overall response was not assessed for the phase 1 portion.
Best overall response was assessed by radioiodine uptake. Complete response (CR) is increased Rai (radioiodine) uptake on post- valproic acid therapy at week 10, AND a decrease in Tg (thyroglobulin ) level to less than 2 ng/ml (or a decrease in Tg-Ab (thyroglobulin antibodies) level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.
Outcome measures
| Measure |
A - Phase 1 Radioiodine Resistant Thyroid Cancer
n=8 Participants
Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
|
B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)
Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
|
|---|---|---|
|
Best Overall Response
Partial Response (PR)
|
0 Participants
|
—
|
|
Best Overall Response
Complete Response (CR)
|
0 Participants
|
—
|
|
Best Overall Response
Stable Disease (SD)
|
1 Participants
|
—
|
|
Best Overall Response
Progressive Disease (PD)
|
6 Participants
|
—
|
|
Best Overall Response
Unknown
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Entry to study and after 10 weeks of treatmentPopulation: There is no standard of error to report. The acronym GAPDH expanded is glyceraldehyde 3-phosphate dehydrogenase. Only 1 participant was analyzed because biopsies were not performed in 12 subjects.
NIS (Na/I-symporter) Expression is assessed by quantitative reverse transcription (RT) polymerase chain reaction (PCR) and immunohistochemistry (IHC). NIS mRNA expression was measured by quantitative RT PCR from biopsy samples.
Outcome measures
| Measure |
A - Phase 1 Radioiodine Resistant Thyroid Cancer
n=1 Participants
Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
|
B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)
Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
|
|---|---|---|
|
NIS (Na/I-symporter) Expression
Pre-treatment NIS expression (relative to GAPDH)
|
21 percent expression
Standard Error 0
|
—
|
|
NIS (Na/I-symporter) Expression
Post-treatment NIS expression (relative to GAPDH)
|
25 percent expression
Standard Error 0
|
—
|
Adverse Events
All Participants (Phase 1 and Phase 2 Schedule 2)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants (Phase 1 and Phase 2 Schedule 2)
n=13 participants at risk
A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
|
|---|---|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
Other adverse events
| Measure |
All Participants (Phase 1 and Phase 2 Schedule 2)
n=13 participants at risk
A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
5/13 • Number of events 7 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Investigations
Creatinine increased
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Eye disorders
Diarrhea
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
General disorders
Fatigue
|
15.4%
2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.1%
3/13 • Number of events 4 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.4%
2/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Investigations
Lymphocyte count decreased
|
38.5%
5/13 • Number of events 8 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Investigations
Platelet count decreased
|
23.1%
3/13 • Number of events 3 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Investigations
Serum amylase increased
|
7.7%
1/13 • Number of events 1 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
|
Investigations
White blood cell decreased
|
7.7%
1/13 • Number of events 2 • Date treatment consent signed to date off study, approximately 41 months and 11 days
Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study. No adverse events were recorded for participants at University of California San Francisco (UCSF).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place