A Phase 1/2 interventional study of Azacitidine (Vidaza) and Nab-paclitaxel (Abraxane) in Advanced or Metastatic Solid Tumors and Advanced or Metastatic Breast Cancer, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-26.
Sponsored by University of Utah · Phase 1/2, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants enrolled.
Drug: Azacitidine (Vidaza) · Drug: Nab-paclitaxel (Abraxane)
50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Also known as: Vidaza
100mg/m2 weekly for 3 weeks of each 4-week cycle
Also known as: Abraxane
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.
Time frame: 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.
Time frame: 1.5 years
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).
Time frame: 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.
Time frame: 2 years
| Milestone | Phase 1 | Phase II |
|---|---|---|
| Started | 16 | 14 |
| Completed | 13 | 13 |
| Not completed | 3 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Disease progression | 2 | 0 |
| Withdrew: Noncompliance | 1 | 0 |
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.
| percent of participants with response | Phase 1 |
|---|---|
| Phase I: Percentage of Participants Responding to Treatment | 61.5 (35 to 87.95) |
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.
| percentage of participants | Phase II |
|---|---|
| Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria | 53.8 (26.7 to 80.9) |
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).
| participants were ER+ | Phase II |
|---|---|
| Number of Participants With ER+ Status | 11 |
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.
No measurements were reported for this outcome.
Collected over Approximately 6 months. Adverse events will be assessed from the first day of treatment until at least 28 days after the last treatment or until all serious or study-related toxicities have resolved or are determined to be stable.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I and II | 0/30 (0%) | 0/30 (0%) | 30/30 (100%) |
| Event | Phase I and II |
|---|---|
| FatigueGeneral disorders | 18/30 |
| NeuropathyNervous system disorders | 14/30 |
| White Blood Cell DecreasedInvestigations | 13/30 |
| NauseaGastrointestinal disorders | 11/30 |
| NeutropeniaInvestigations | 11/30 |
| AlopeciaSkin and subcutaneous tissue disorders | 10/30 |
| AnemiaBlood and lymphatic system disorders | 8/30 |
| VomitingGastrointestinal disorders | 7/30 |
| DiarrheaGastrointestinal disorders | 6/30 |
| DizzinessNervous system disorders | 6/30 |
In the Phase I cohort, two patients stopped during Cycle I due to disease progression, and one was removed in cycle 4 due to noncompliance. In the Phase II cohort, one patient opted out after 1 cycle because of toxicity.
| Age, Continuous(years) | Phase II | Phase I | Total |
|---|---|---|---|
| Median | 65 (38 to 77) | 62 (21 to 83) | 63.5 (21 to 83) |
| Sex: Female, Male(Participants) | Phase II | Phase I | Total |
|---|---|---|---|
| Female | 14 | 13 | 27 |
| Male | 0 | 3 | 3 |
| Race (NIH/OMB)(Participants) | Phase II | Phase I | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 5 | 7 |
| White | 12 | 10 | 22 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Phase II | Phase I | Total |
|---|---|---|---|
| United States | 14 | 16 | 30 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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