Pulsed Abraxane and Radiotherapy for Improving and Maintaining Ambulation After Cancer-Related Cord Compression
Study Details
Study Description
Brief Summary
The purpose of this research study is to look at a combination treatment of radiation therapy and a drug called Abraxane to treat epidural spinal cord compression.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: nab-Paclitaxel and Radiation Therapy 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
Radiation: Radiation therapy
Using the View Ray System
Drug: nab-Paclitaxel
Dose 15 mg/m^2
Should be administered by IV over 30 minutes
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Ambulatory Status [1 month]
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
Secondary Outcome Measures
- Ambulatory Status [3 months]
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
- Ambulatory Status [6 months]
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
- Ambulatory Status [9 months]
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
- Ambulatory Status [12 months]
-Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid.
- Strength of Lower Extremities [1 month]
-Strength assessment is categorized as follows: 0/5=no contraction (worst); 1/5=muscle flicker, but no movement; 2/5=movement possible, but not against gravity (test the joint in its horizontal plane); 3/5=movement possible against gravity, but not against resistance by the examiner; 4/5=movement possible against some resistance by the examiner; 5/5=normal strength (best)
- Pain in the Irradiated Area" Measured on a Scale [1 month]
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
- Pain in the Irradiated Area Measured on a Scale [3 months]
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
- Pain in the Irradiated Area Measured on a Scale [6 months]
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
- Pain in the Irradiated Area Measured on a Scale [9 months]
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
- Pain in the Irradiated Area Measured on a Scale [12 months]
-Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with ≤ 37 points per the scoring system listed in the protocol
-
Histologically or cytologically confirmed diagnosis of cancer not of CNS or spinal column origin.
-
MRI or CT evidence of metastatic epidural spinal cord compression.
-
Patients who have started 30 Gy in 10 fractions are not excluded as long as 4 doses of chemotherapy could potentially be given. This means the latest nab-paclitaxel can start is the morning of the third fraction of radiotherapy. Radiotherapy should ideally be delivered at least 6 hours after the nab-paclitaxel infusion started.
-
At least 18 years of age.
-
Normal bone marrow and organ function as defined below:
-
Absolute neutrophil count ≥ 1,500 cells/mm3
-
Platelets ≥ 100,000 cells/mm3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to blood draw)
-
Hemoglobin > 9.0 g/dL
-
Total bilirubin ≤ 1.5 mg/dL
-
AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
-
Alkaline phosphatase ≤ 2.5 x IULN (unless bone metastasis is present (< 5 x IULN) in the absence of liver metastasis)
-
Creatinine ≤ 1.5 mg/dL
-
Women of childbearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months) must:
-
Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting treatment with nab-paclitaxel and while on study; and
-
Have a negative serum pregnancy test result at screening and agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact.
-
Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 6 months following nab-paclitaxel discontinuation, even if he has undergone a successful vasectomy.
-
Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
-
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
-
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test prior to study entry.
-
Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with nab-paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
-
Previous spinal cord radiotherapy that would overlap with the proposed treatment field.
-
Spinal instability or bony retropulsion causing the cord compression. That is, mechanical, not tumor, cord compression. In these cases surgery may be indicated.
-
Patients eligible for surgical decompression like laminectomy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- Celgene
Investigators
- Principal Investigator: Hiram A Gay, M.D., Washington University School of Medicine
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 201809175
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Period Title: Overall Study | |
| STARTED | 2 |
| COMPLETED | 2 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Overall Participants | 2 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
47.5
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1
50%
|
| Male |
1
50%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
2
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
2
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
2
100%
|
Outcome Measures
| Title | Ambulatory Status |
|---|---|
| Description | -Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid. |
| Time Frame | 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant was not evaluable for this outcome measure because the ambulatory status was not completed for the participant. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 1 |
| Paraplegic |
0
0%
|
| Not ambulatory |
1
50%
|
| Ambulatory with aid |
0
0%
|
| Ambulatory without aid |
0
0%
|
| Title | Ambulatory Status |
|---|---|
| Description | -Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid. |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant was not evaluable for this outcome measure because the ambulatory status was not completed for the participant. One participant was not evaluable for this outcome measure because the participant died prior to the 3 month follow-up. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 0 |
| Title | Ambulatory Status |
|---|---|
| Description | -Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Both participants expired prior to the 6 month follow-up. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 0 |
| Title | Ambulatory Status |
|---|---|
| Description | -Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid. |
| Time Frame | 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Both participants expired prior to the 9 month follow-up. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 0 |
| Title | Ambulatory Status |
|---|---|
| Description | -Ambulatory status is categorized as paraplegic, not ambulatory, ambulatory with aid (for example, with assistive device like walker or crutches), and ambulatory without aid. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Both participants expired prior to the 12 month follow-up. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 0 |
| Title | Strength of Lower Extremities |
|---|---|
| Description | -Strength assessment is categorized as follows: 0/5=no contraction (worst); 1/5=muscle flicker, but no movement; 2/5=movement possible, but not against gravity (test the joint in its horizontal plane); 3/5=movement possible against gravity, but not against resistance by the examiner; 4/5=movement possible against some resistance by the examiner; 5/5=normal strength (best) |
| Time Frame | 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant was not evaluable for this outcome measure because the strength of lower extremities was not completed for the participant. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 1 |
| 0=no contraction |
0
0%
|
| 1=muscle flicker, but no movement |
0
0%
|
| 2=movement possible, but not against gravity (test the joint in its horizontal plane) |
0
0%
|
| 3=movement possible against gravity, but not against resistance by the examiner |
1
50%
|
| 4=movement possible against some resistance by the examiner |
0
0%
|
| 5=normal strength |
0
0%
|
| Title | Pain in the Irradiated Area" Measured on a Scale |
|---|---|
| Description | -Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst) |
| Time Frame | 1 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant was not evaluable for this outcome measure because the pain scale was not completed for the participant. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 1 |
| 0 |
0
0%
|
| 1 |
0
0%
|
| 2 |
0
0%
|
| 3 |
0
0%
|
| 4 |
0
0%
|
| 5 |
1
50%
|
| 6 |
0
0%
|
| 7 |
0
0%
|
| 8 |
0
0%
|
| 9 |
0
0%
|
| 10 |
0
0%
|
| Title | Pain in the Irradiated Area Measured on a Scale |
|---|---|
| Description | -Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst) |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant was not evaluable for this outcome measure because the pain status was not completed for the participant. One participant was not evaluable for this outcome measure because the participant died prior to the 3 month follow-up. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 0 |
| Title | Pain in the Irradiated Area Measured on a Scale |
|---|---|
| Description | -Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst) |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Both participants expired prior to the 6 month follow-up. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 0 |
| Title | Pain in the Irradiated Area Measured on a Scale |
|---|---|
| Description | -Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst) |
| Time Frame | 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Both participants expired prior to the 9 month follow-up. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 0 |
| Title | Pain in the Irradiated Area Measured on a Scale |
|---|---|
| Description | -Pain is measured on a scale between 0-10. 0=no pain (best) and 10=the greatest pain (worst) |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Both participants expired prior to the 12 month follow-up. |
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy |
|---|---|
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks |
| Measure Participants | 0 |
Adverse Events
| Time Frame | From start of treatment through 28 days after completion of treatment (estimated to be 6 weeks) . Late toxicities for radiation therapy will be collected for 1 year after the end of radiation therapy (estimated to be 1 year and 2 weeks) | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Nab-Paclitaxel and Radiation Therapy | |
| Arm/Group Description | 10 fractions of 3Gy radiation therapy will be delivered. A total of 4 chemoradiation blocks should be delivered ideally in consecutive days On day 1 of the chemoradiation block, nab-paclitaxel is delivered in the morning followed by radiotherapy the latest possible and ideally at least 6 hours later (no earlier than 4 hours after the start of nab-paclitaxel) On day 2, radiotherapy is delivered in the morning, ideally within 24 hours from the start of nab-Paclitaxel infusion the previous day There will be 2 radiation fractions that won't be part of any chemoradiation block and can be placed anywhere before, after, or between blocks | |
All Cause Mortality |
||
| Nab-Paclitaxel and Radiation Therapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/2 (100%) | |
Serious Adverse Events |
||
| Nab-Paclitaxel and Radiation Therapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/2 (50%) | |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 1/2 (50%) | |
| Nervous system disorders | ||
| Paresthesia | 1/2 (50%) | |
Other (Not Including Serious) Adverse Events |
||
| Nab-Paclitaxel and Radiation Therapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/2 (100%) | |
| Eye disorders | ||
| Blurred vision | 1/2 (50%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/2 (50%) | |
| Fecal incontinence | 1/2 (50%) | |
| General disorders | ||
| Disease progression | 2/2 (100%) | |
| Fatigue | 1/2 (50%) | |
| Infections and infestations | ||
| Thrush | 1/2 (50%) | |
| Investigations | ||
| Lymphocyte count decreased | 1/2 (50%) | |
| White blood cell decreased | 1/2 (50%) | |
| Metabolism and nutrition disorders | ||
| Hypocalcemia | 1/2 (50%) | |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 1/2 (50%) | |
| Muscle weakness upper limb | 1/2 (50%) | |
| Myalgia | 1/2 (50%) | |
| Neck pain | 1/2 (50%) | |
| Pain in extremity | 1/2 (50%) | |
| Nervous system disorders | ||
| Headache | 1/2 (50%) | |
| Vascular disorders | ||
| Hypertension | 1/2 (50%) | |
| Thromboembolic event | 1/2 (50%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Hiram A. Gay, M.D. |
|---|---|
| Organization | Washington University School of Medicine |
| Phone | 314-362-8516 |
| hiramgay@wustl.edu |
- 201809175