Advanced Solid TumorPhase 1NCT01673438
Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCL in Subjects With Advanced Solid Tumors
A Phase 1 study testing aldoxorubicin in people with Advanced Solid Tumor, run by ImmunityBio, Inc. at 1 site in United States.
Trial summary
This is a phase 1b open-label study to investigate the safety and maximum tolerated dose of aldoxorubicin plus doxorubicin HCl adminstered as infusion every 3 weeks for up to 8 cycles in subjects with advance solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- aldoxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female.
- Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy or no standard chemotherapy exists.
- Capable of providing informed consent and complying with trial procedures.
- Baseline absolute left ventricular ejection fraction (LVEF) measured scintigraphically (MUGA, myocardial scintigram) or by ultrasound (echocardiogram) ≥ Institutional Lower Limit of Normal.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Life expectancy > 12 weeks.
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- Measurable or evaluable disease according to RECIST 1.1 criteria.15
- Women must not be able to become pregnant (e.g., 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 that the subject will be able to keep all study-related appointments.
Who cannot join
- Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment < 4 weeks prior to the Screening Visit.
- Prior treatment with ≥ 150 mg/m2 doxorubicin HCl or Doxil® cumulative dose, or epirubicin ≥ 150 mg/m2.
- Exposure to any investigational agent within 30 days of Randomization.
- Evidence of active or uncontrolled central nervous system (CNS) metastasis (negative imaging study performed due to suspicion of CNS metastasis within 4 weeks of Screening Visit).
- History of other malignancies except cured basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.
- Laboratory values: Screening serum creatinine ≥ 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the ULN if no liver metastases or 5 times the ULN if liver metastases, total bilirubin > 2 times the ULN, white blood cell (WBC) count < 3500/mm3, or absolute neutrophil count (ANC) < 1500/mm3, platelet concentration < 100,000/mm3, hematocrit level < 25% for females or < 27% for males, or coagulation tests (prothrombin time [PT]; partial thromboplastin time [PTT]), International Normalized Ration (INR) > 1.5 times the ULN, serum albumin < 2.0g/dL.
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- Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
- Baseline QTc > 470 msec and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QTc prolongation is not allowed.
- Serious clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- History or signs of active coronary artery disease with or without angina pectoris.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
Official title: An Open-Label Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCL Administered as Infusions Every 3 Weeks in Subjects With Advanced Solid Tumors
This is a phase 1b open-label study to investigate the safety and maximum tolerated dose of aldoxorubicin plus doxorubicin HCl adminstered as infusion every 3 weeks for up to 8 cycles in subjects with advance solid tumors.
Read the detailed description
An Open-Label Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCl Administered as Infusions Every 3 Weeks in Subjects with Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Being tested
- aldoxorubicin
- Keywords
- solid tumor, aldoxorubicin, phase 1, INNO-206, doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldoxorubicinDrug
Also called INNO-206
| Study group | Role | What they receive |
|---|---|---|
| Aldoxorubicin plus doxorubicin | Experimental | Aldoxorubicin dosages of 175, 240, and 320 (doxorubicin equivalents of 130, 180, and 240 mg/m2) will be administered as a 30 minutes IVI on Day 1 of each cycle. In addition 35 mg/m2 of doxorubicin HCl will be administered as an IVI over > 3 minutes no later than 3 hours, but no more than 6 hours before the start of aldoxorubicin infusion. Receives: Drug: aldoxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The primary objective of this study is to determine the preliminary safety and maximum tolerated dose (MTD) of aldoxorubicin plus doxorubicin HCl in subjects with advanced solid tumors who have failed standard therapies.
Measured: up to 6 months
Secondary outcomes (1)
Tumor Response
The secondary objective of this study is to evaluate the tumor response to aldoxorubicin plus doxorubicin HCl in this population assessed by radiographic means using the RECIST 1.1 criteria.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Levitt, MD, Study director, CytRx Coorporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673438
- Sponsor's protocol ID
- ALDOXORUBICIN-P1-MTD-02
- Status last verified
- Apr 2014
- First submitted
- 21 Aug 2012
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCL Administered as Infusions Every 3 Weeks in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01673438
- Acronym / sponsor ID
- ALDOXORUBICIN-P1-MTD-02
- Conditions
- Advanced Solid Tumor
- Keywords
- solid tumor, aldoxorubicin, phase 1, INNO-206, doxorubicin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1b open-label study to investigate the safety and maximum tolerated dose of aldoxorubicin plus doxorubicin HCl adminstered as infusion every 3 weeks for up to 8 cycles in subjects with advance solid tumors.
Detailed description
An Open-Label Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCl Administered as Infusions Every 3 Weeks in Subjects with Advanced Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aldoxorubicin plus doxorubicin | Experimental | Drug: aldoxorubicinAldoxorubicin dosages of 175, 240, and 320 (doxorubicin equivalents of 130, 180, and 240 mg/m2) will be administered as a 30 minutes IVI on Day 1 of each cycle. In addition 35 mg/m2 of doxorubicin HCl will be administered as an IVI over > 3 minutes no later than 3 hours, but no more than 6 hours before the start of aldoxorubicin infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, male or female.
- Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy or no standard chemotherapy exists.
- Capable of providing informed consent and complying with trial procedures.
- Baseline absolute left ventricular ejection fraction (LVEF) measured scintigraphically (MUGA, myocardial scintigram) or by ultrasound (echocardiogram) ≥ Institutional Lower Limit of Normal.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
Key exclusion criteria (10 listed)
- Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment < 4 weeks prior to the Screening Visit.
- Prior treatment with ≥ 150 mg/m2 doxorubicin HCl or Doxil® cumulative dose, or epirubicin ≥ 150 mg/m2.
- Exposure to any investigational agent within 30 days of Randomization.
- Evidence of active or uncontrolled central nervous system (CNS) metastasis (negative imaging study performed due to suspicion of CNS metastasis within 4 weeks of Screening Visit).
- History of other malignancies except cured basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldoxorubicinAlso: INNO-206 | Drug | Aldoxorubicin plus doxorubicin |
Primary outcome
Safety and Tolerability
Time frame: up to 6 months
The primary objective of this study is to determine the preliminary safety and maximum tolerated dose (MTD) of aldoxorubicin plus doxorubicin HCl in subjects with advanced solid tumors who have failed standard therapies.
1 secondary outcome
Tumor Response
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Levitt, MD study director
CytRx Coorporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aldoxorubicin in people with Advanced Solid Tumor, run by ImmunityBio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.