Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02235701 · ClinicalTrials.gov registry record · Phase 1

Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma

A Phase 1 study of Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma, sponsored by ImmunityBio.

Completed
Registry status
Phase 1
Development phase
70
Enrollment target
1
Study location

NCT02235701: Completed Phase 1 study of Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma, sponsored by ImmunityBio.

NCT02235701 is a Phase 1 study of Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma that has completed, run by ImmunityBio. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02235701, a Phase 1 study of Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma, has completed, sponsored by ImmunityBio.

COMPLETED
Registry status
Phase 1
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.

Primary Outcome

The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in subjects with metastatic, locally advanced, or unresectable soft tissue sarcoma as measured by the frequency and severity of adverse events (AEs). The following assessments were used to determine if subjects had adverse events: * vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area) * physical

Interventions

  • DRUG 250 mg/m2 aldoxorubicin
  • DRUG 170 mg/m2 aldoxorubicin

Study Locations (1)

California

  • Sarcoma Oncology Center - Santa Monica

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2014-09-02
Est. Completion 2018-05-01
Phase Phase 1
ImmunityBio

46 total trials

What the finished NCT02235701 record still lists

NCT02235701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).

The record links to 1 condition, with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which 250 mg/m2 aldoxorubicin is the first listed.

NCT02235701 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT02235701 about?

NCT02235701 is a clinical study titled "Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma". This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.

What is the current status of trial NCT02235701?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2014-09-02. Estimated completion is 2018-05-01.

What conditions does trial NCT02235701 study?

This clinical trial studies the following conditions: Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma.

What interventions are being tested in trial NCT02235701?

The interventions under investigation include: 250 mg/m2 aldoxorubicin (DRUG), 170 mg/m2 aldoxorubicin (DRUG).

Who is sponsoring clinical trial NCT02235701?

This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02235701 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02235701's enrollment target sits among peer trials

70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00969111 · 70 participants · NA

    Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

  • NCT01712620 · 70 participants · Phase 2

    Spironolactone for Pulmonary Arterial Hypertension

  • NCT02143830 · 70 participants · Phase 2

    HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy

  • NCT02601339 · 70 participants

    NIRS Monitoring in Premature Infants

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT02235701, the US trial registry maintained by the National Library of Medicine. NCT02235701 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.