Advanced or Metastatic Solid TumorsPhase 1/2VANCT00748553
A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer
A Phase 1/2 study testing Azacitidine (Vidaza) and Nab-paclitaxel (Abraxane) in people with Advanced or Metastatic Solid Tumors and Advanced or Metastatic Breast Cancer, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors, Advanced or Metastatic Breast Cancer
- What is being tested?
- Azacitidine (Vidaza) and Nab-paclitaxel (Abraxane)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Oct 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable.
- For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.
- Her-2/neu negative (Phase II)
- Negative pregnancy test for female subjects
- Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator.
- Male or female for phase I and female for phase II, >19 years of age and any race.
Who cannot join
- Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
- Known brain metastases
- Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
- Active infection requiring antibiotic therapy
- History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
- Grade 2 or greater motor or sensory neuropathy
Show all 13Show fewer
- Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
- Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
- Known or suspected hypersensitivity to azacitidine or mannitol
- Pregnant or breast feeding
- Patients with advanced malignant hepatic tumors
- Malignancy other than breast carcinoma (phase II)
- Known HIV infection or chronic hepatitis B or C
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer
The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.
Read the detailed description
The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in.
- Being tested
- Azacitidine (Vidaza), Nab-paclitaxel (Abraxane)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine (Vidaza)Drug
Also called Vidaza
50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Nab-paclitaxel (Abraxane)Drug
Also called Abraxane
100mg/m2 weekly for 3 weeks of each 4-week cycle
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All participants enrolled. Receives: Drug: Azacitidine (Vidaza); Drug: Nab-paclitaxel (Abraxane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Percentage of Participants Responding to Treatment
Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.
Measured: 6 months
Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria
Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized.
For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease consists of neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Measured: 1.5 years
Secondary outcomes (2)
Number of Participants With ER+ Status
Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days).
Measured: 2 years
Progression-free Survival
Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Hung T Khong, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748553
- Sponsor's protocol ID
- HCI53993
- Acronym
- VA
- Status last verified
- Jun 2017
- First submitted
- 4 Sep 2008
- Last updated
- 26 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer
- ClinicalTrials.gov ID
- NCT00748553
- Acronym / sponsor ID
- VA / HCI53993
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Sep 2008
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Posted 26 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.
Detailed description
The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: Azacitidine (Vidaza), Drug: Nab-paclitaxel (Abraxane)All participants enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable.
- For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.
- Her-2/neu negative (Phase II)
- Negative pregnancy test for female subjects
- Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator.
Key exclusion criteria (13 listed)
- Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
- Known brain metastases
- Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
- Active infection requiring antibiotic therapy
- History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
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 |
|---|---|---|
| Azacitidine (Vidaza)Also: Vidaza50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle | Drug | All patients |
| Nab-paclitaxel (Abraxane)Also: Abraxane100mg/m2 weekly for 3 weeks of each 4-week cycle | Drug | All patients |
Primary outcome
Phase I: Percentage of Participants Responding to Treatment
Time frame: 6 months
Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.
Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria
Time frame: 1.5 years
Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized. For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease consists of neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
2 secondary outcomes
Number of Participants With ER+ Status
Time frame: 2 years
Progression-free Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hung T Khong, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Azacitidine (Vidaza) and Nab-paclitaxel (Abraxane) in people with Advanced or Metastatic Solid Tumors and Advanced or Metastatic Breast Cancer, run by University of Utah 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 6 inclusion and 13 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 26 Jul 2017. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase I: Percentage of Participants Responding to Treatment (time frame: 6 months). The study lists 2 primary outcomes in all. 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 26 Jul 2017.