Trial · NCT03468075
Gemcitabine Plus Ascorbate for Sarcoma in Adults
NCT03468075, Phase 2, Terminated, Mohammed Milhem, MBBS; results first posted 2020-12-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine Plus Ascorbate for Sarcoma in Adults. Trials, record NCT03468075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03468075
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine Plus Ascorbate for Sarcoma in Adults
- NCT number
- NCT03468075
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Mohammed Milhem, MBBS
- Conditions
- Sarcoma, Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma, Metastatic Bone Tumor, Bone Sarcoma
- Interventions
- Ascorbate, Gemcitabine
- First posted
- 2018-03-16
- Last updated
- 2020-12-10
- Results first posted
- 2020-12-10
- Limitations and caveats
- Study terminated early. Ten patients were enrolled in the first stage, and per protocol the study was terminated following interim analysis when 1 or fewer participants had a tumor response.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response | Every 2 months for first 6 months, then every 3 months up to 2 years post treatment | From first day of treatment to documented disease progression as described by RECIST 1.1 criteria. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST. |
| Secondary | Progression Free Survival | Every 2 months for first 6 months, then every 3 months up to 2 years post treatment | Time from start of therapy (day 1, cycle 1) to documented disease progression or death due to any cause. Progression will be defined using the RECIST 1.1 guidelines. Results are provided in nominal categories (CR, PR, SD, PD) as per RECIST. |
| Secondary | Overall Survival | Every 2 months for first 6 months, then every 3 months up to 2 years post treatment | Time from start of therapy (day 1, cycle 1) to death. |
| Secondary | Incidence of Adverse Events (AE) Per CTCAE 4.03 | Up to 30 days after completion of study treatment | Categorize and quantify adverse events from start of therapy (day 1, cycle 1) to end of study per (CTCAE) version 4.03. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response | Every 2 months for first 6 months, then every 3 months up to 2 years post treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival | Every 2 months for first 6 months, then every 3 months up to 2 years post treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Every 2 months for first 6 months, then every 3 months up to 2 years post treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Adverse Events (AE) Per CTCAE 4.03 | Up to 30 days after completion of study treatment | adverse events | NUMBER |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response | Gemcitabine + High-Dose Ascorbate | PD | 8 | Participants | |
| Tumor Response | Gemcitabine + High-Dose Ascorbate | SD | 1 | Participants | |
| Tumor Response | Gemcitabine + High-Dose Ascorbate | PR | 1 | Participants | |
| Progression Free Survival | Gemcitabine + High-Dose Ascorbate | 2 months | 7 | Participants | |
| Progression Free Survival | Gemcitabine + High-Dose Ascorbate | 3 months | 1 | Participants | |
| Progression Free Survival | Gemcitabine + High-Dose Ascorbate | 6 months | 1 | Participants | |
| Progression Free Survival | Gemcitabine + High-Dose Ascorbate | 9 months | 1 | Participants | |
| Overall Survival | Gemcitabine + High-Dose Ascorbate | Alive | 5 | Participants | |
| Overall Survival | Gemcitabine + High-Dose Ascorbate | Dead | 5 | Participants | |
| Incidence of Adverse Events (AE) Per CTCAE 4.03 | Gemcitabine + High-Dose Ascorbate | Blood and lymphatic system disorders | 4 | adverse events |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcitabine + High-Dose Ascorbate | 10 | |
| Overall Study | COMPLETED | Gemcitabine + High-Dose Ascorbate | 10 | |
| Overall Study | NOT COMPLETED | Gemcitabine + High-Dose Ascorbate | 0 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Gemcitabine + High-Dose Ascorbate | 2 | 10 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Gemcitabine + High-Dose Ascorbate | 1 | 10 | 1 |
| other | Ascites | Gastrointestinal disorders | Gemcitabine + High-Dose Ascorbate | 1 | 10 | 1 |
| other | Constipation | Gastrointestinal disorders | Gemcitabine + High-Dose Ascorbate | 2 | 10 | 2 |
| other | Nausea | Gastrointestinal disorders | Gemcitabine + High-Dose Ascorbate | 2 | 10 | 2 |
| other | Vomiting | Gastrointestinal disorders | Gemcitabine + High-Dose Ascorbate | 1 | 10 | 1 |
| other | Chills | General disorders | Gemcitabine + High-Dose Ascorbate | 1 | 10 | 1 |
| other | Edema limbs | General disorders | Gemcitabine + High-Dose Ascorbate | 1 | 10 | 1 |
| other | Fatigue | General disorders | Gemcitabine + High-Dose Ascorbate | 1 | 10 | 1 |
| other | Fever | General disorders | Gemcitabine + High-Dose Ascorbate | 2 | 10 | 3 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine + High-Dose Ascorbate | 6 | 10 |
| Total, other adverse events | Gemcitabine + High-Dose Ascorbate | 9 | 10 |
| Total, serious adverse events | Gemcitabine + High-Dose Ascorbate | 2 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03468075
GET https://conductscience.org/api/trials/v1/NCT03468075/results?page=2