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

NCT02235701 | Completed Phase 1 Results

• 1 other identifier: ALDOXORUBICIN-P1/2-STS-03
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma

Keywords

soft tissue sarcoma; aldoxorubicin; ifosfamide; mesna; phase 1; INNO-206

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events in Participants

  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 examination * laboratory tests (chemistry, hematology, urinalysis, anion gap) additionally, the following scans were performed to determine adverse events: * ECHO / MUGA * ECG

  Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs (up to 766 days).

Study Arms (2)

170 mg/m2 aldoxorubicin

EXPERIMENTAL

Drug: 170 mg/m2 aldoxorubicin

250 mg/m2 aldoxorubicin

EXPERIMENTAL

Drug: 250 mg/m2 aldoxorubicin

Interventions

170 mg/m2 aldoxorubicin DRUG

administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days

170 mg/m2 aldoxorubicin

250 mg/m2 aldoxorubicin DRUG

administered at 250 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days

250 mg/m2 aldoxorubicin

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 15-80 years, male or female.
• Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor recurrence for at least 12 months since the last measurement, beginning or end of last chemotherapy.
• Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic soft tissue sarcoma (including rhabdomyosarcoma, Ewing's sarcoma and mixed mesodermal sarcoma), chondrosarcoma or osteosarcoma of intermediate or high grade and gastrointestinal stromal tumors (GIST) (only in subjects that have progressed after receiving treatment with imatinib and sunitinib).
• Capable of providing informed consent and complying with trial procedures.
• ECOG performance status 0-2.
• Life expectancy \>12 weeks.
• Measurable tumor lesions according to RECIST 1.1 criteria.
• Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
• Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
• Geographic accessibility to the site that ensures the subject will be able to keep all study-related appointments.

You may not qualify if:

• Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence for at least 12 months.
• Prior exposure to \>3 cycles or 225 mg/m2 of doxorubicin or Doxil®.
• Palliative surgery and/or radiation treatment less than 30 days prior to enrollment.
• Exposure to any investigational agent within 30 days of enrollment.
• Current Stage 1 or 2 soft tissue sarcomas.
• Current evidence/diagnosis of alveolar soft part sarcoma, dermatofibrosarcoma, Kaposi's sarcoma, clear cell sarcomas and unresectable low grade liposarcomas.
• Central nervous system metastasis if symptomatic.
• History of other malignancies except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥ 5 years.
• Laboratory values: Screening serum creatinine \>1.5x upper limit of normal (ULN), alanine aminotransferase (ALT) \> 3 × ULN or \>5 × ULN if liver metastases are present, total bilirubin \>3 × ULN, absolute neutrophil count \<1,500/mm3, platelet concentration \<100,000/mm3, hematocrit level \<25% for females or \<27% for males, albumin \<2 gm/dL, coagulation tests (prothrombin time \[PT\], partial thromboplastin time \[PTT\], International Normalized Ratio \[INR\]) \>1.5 × ULN.
• Clinically evident congestive heart failure \> class II of the New York Heart Association (NYHA) guidelines.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Neoplasm Metastasis; Sarcoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@Immunitybio.com

855-797-9277

Study Officials

• Dan Levitt, M.D.

  CytRx Coporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: September 10, 2014
• Study Start: September 2, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2016-10

Locations

US (1)