NCT03468075 is a Phase 2 clinical trial of Ascorbate in Sarcoma, sponsored by Mohammed Milhem, MBBS.

Who is sponsoring NCT03468075?

NCT03468075 is sponsored by Mohammed Milhem, MBBS.

What drugs are being tested in NCT03468075?

Interventions in NCT03468075: Ascorbate, Gemcitabine.

What condition does NCT03468075 study?

NCT03468075 studies Sarcoma, Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma, Metastatic Bone Tumor, Bone Sarcoma.

Is NCT03468075 still recruiting?

NCT03468075 is currently terminated. Last updated 10 December 2020.

Are results published for NCT03468075?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-12-10 · How we verify

NCT03468075

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Gemcitabine Plus Ascorbate for Sarcoma in Adults

Terminated Phase 2 Results posted Last updated 10 December 2020

What this trial tests

Phase 2 trial testing Ascorbate in Sarcoma in 10 participants. Terminated before completion.

Timeline

11 July 2018

Primary endpoint
16 April 2019

19 October 2020

Quick facts

Lead sponsor	Mohammed Milhem, MBBS
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	11 July 2018
Primary completion	16 April 2019
Estimated completion	19 October 2020
Sites	1 location across United States

Drugs / interventions tested

Ascorbate — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

Sarcoma — all drugs for Sarcoma →
Soft Tissue Sarcoma — all drugs for Soft Tissue Sarcoma →
Unresectable Soft Tissue Sarcoma — all drugs for Unresectable Soft Tissue Sarcoma →
Metastatic Bone Tumor — all drugs for Metastatic Bone Tumor →

Sponsor

Mohammed Milhem, MBBS — full company profile →

Who can join

18 and older, any sex, with Sarcoma or Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tumor Response Primary · 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.

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	8

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	1

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	1

Progression Free Survival Secondary · 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.

2 months

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	7

3 months

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	1

6 months

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	1

9 months

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	1

Overall Survival Secondary · 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.

Alive

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	5

Dead

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	5

Incidence of Adverse Events (AE) Per CTCAE 4.03 Secondary · 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.

Blood and lymphatic system disorders

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	4

Gastrointestinal disorders

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	7

Infections and infestations

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	1

Investigations

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	43

Metabolism and nutrition disorders

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	2

Musculoskeletal and connective tissue disorders

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	1

Psychiatric disorders

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	1

Renal and urinary disorders

Group	Value	95% CI
Gemcitabine + High-Dose Ascorbate	1

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs were collected up to 30 days after completion of study treatment, up to 7 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gemcitabine + High-Dose Ascorbate

Serious: 2/10 (20%)

Deaths: 6/10

Serious adverse events (3 terms)

Reaction	System	Gemcitabine + High-Dose As…
Abdominal pain	Gastrointestinal disorders	—
Fever	General disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (32 terms — click to expand)

Reaction	System	Gemcitabine + High-Dose As…
Neutrophil count decreased	Investigations	—
Platelet count decreased	Investigations	—
Respiratory, thoracic and mediastinal disorders - Other, specify	Respiratory, thoracic and mediastinal disorders	—
Anemia	Blood and lymphatic system disorders	—
Constipation	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Fever	General disorders	—
Alanine aminotransferase increased	Investigations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Hypertension	Vascular disorders	—
Abdominal pain	Gastrointestinal disorders	—
Ascites	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Chills	General disorders	—
Edema limbs	General disorders	—
Fatigue	General disorders	—
Pain	General disorders	—
Upper respiratory infection	Infections and infestations	—
Aspartate aminotransferase increased	Investigations	—
Blood bilirubin increased	Investigations	—
GGT increased	Investigations	—
Weight loss	Investigations	—
Anorexia	Metabolism and nutrition disorders	—
Metabolism and nutrition disorders - Other, specify	Metabolism and nutrition disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Insomnia	Psychiatric disorders	—
Hematuria	Renal and urinary disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Abdominal pain, Fever, Dyspnea.

Data from ClinicalTrials.gov NCT03468075 adverse events section.

Sponsor's own description

This study will enroll patients who have a diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except gastrointestinal stromal tumors and Kaposi's sarcoma) from any site.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Balanced Duality: H<sub>2</sub>O<sub>2</sub>-Based Therapy in Cancer and Its Protective Effects on Non-Malignant Tissues.
Zaher A, Petronek MS, Allen BG, Mapuskar KA. · · 2024 · cited 11× · PMID 39201571 · DOI 10.3390/ijms25168885

Verify or expand the search:

Other trials of Ascorbate

Trials testing the same drug.

NCT03541486 — A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients · Phase 2 · withdrawn
NCT06018896 — Vitamin C to Quality of Life in Patients With Terminal Stage Pancreatic Cancer · Phase 2 · recruiting
NCT06018883 — Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer · Phase 3 · active not recruiting
NCT04634227 — Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot) · EARLY_PHASE1 · active not recruiting
NCT03508726 — High Dose Ascorbate With Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas · Phase 1, PHASE2 · completed

Other recruiting trials for Sarcoma

Currently open trials in the same condition.

NCT07402577 — Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot · recruiting
NCT07501026 — Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC) · Phase 2 · recruiting
NCT07359911 — Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patient · NA · recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03468075 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mohammed Milhem, MBBS
Last refreshed: 10 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03468075.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing