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TerminatedNCT01227018Updated Jul 23, 2014Results posted

PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer

A Phase 2 interventional study of STA-9090 and Radiologic imaging in Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer and Stage IV Pancreatic Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-23.

Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Treatment

Why this study was terminated
interim analysis found the study drug to be ineffective
Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Heat shock protein (HSP)90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. PURPOSE: This phase II trial is studying how well hsp90 inhibitor STA-9090 works as second- or third-line therapy for the treatment of patients with metastatic pancreatic cancer.

Read the detailed description

PRIMARY OBJECTIVES: I. To measure the 8-week disease control (CR + PR + SD) rate of therapy with STA-9090 in patients with metastatic pancreas cancer who have failed (either progressed or did not tolerate) one or two lines of prior therapy. SECONDARY OBJECTIVES: I. To determine response rate (by RECIST criteria v1.1). II. To determine overall survival. III. To evaluate the safety and toxicity profile in this patient population. TERTIARY OBJECTIVES: I. We will obtain from all patients blood samples pre and post therapy (after 1 week of therapy) and isolate serum for interrogation for a variety of biomarkers (eg AKT, Stat3, Caspase 3). OUTLINE: Patients receive Hsp90 inhibitor STA-9090 intravenous (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks.

02

Conditions studied

  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 15 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Microscopic confirmation of a diagnosis of metastatic adenocarcinoma (pathology may be from either the primary tumor or metastatic lesion) or poorly differentiated carcinoma of the pancreas s/p 1 or 2 prior chemotherapy regimens for metastatic disease (excluding neuroendocrine tumors, periampullary tumors and cystadenocarcinoma)
  • Patients who received adjuvant or neoadjuvant therapy will be eligible if they have progressed within 6 months of completing therapy and have not received a metastatic regimen or if they progressed > 6 months after completing therapy and have received 1-2 lines of therapy for metastatic disease
  • Measurable disease by RECIST criteria
  • ECOG PS 0 or 1
  • Life expectancy of at least 12 weeks
  • Absolute neutrophil count (ANC) >= 1,500/mm\^3
  • Platelet count >= 100,000/mm\^3
  • Creatinine =\< 2.0 mg/dl
  • Total bilirubin =\< 2.0 mg/dl
  • AST and ALT =\< 2.5 x ULN in absence of liver metastasis; =\< 5 x ULN in presence of liver metastasis
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of therapy
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
  • Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study-specific procedures

Exclusion criteria

Exclusion Criteria:

  • Primary brain tumors or active brain metastases; however, patients with a history of CNS metastases will be eligible if they have been treated and are stable for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for a minimum of 2 weeks prior to enrollment
  • History of stroke within 6 months of treatment or other significant neurological limitations
  • History of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty of coronary bypass surgery
  • History of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block
  • New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea or edema that required current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics
  • Current or prior radiation therapy to the left hemithorax
  • Major surgery within 4 weeks prior to entering the study
  • Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration; study drug administration via indwelling catheters is prohibited at this time
  • Use of any investigational agents within 4 weeks prior to entering the study
  • History of severe allergic reactions to excipients (e.g., Polyethylene glycol 300 and Polysorbate 80), including severe hypersensitivity reactions defined as >= Grade 3 based on NCI CTCAE version 4.0
  • Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation or systemic steroids for treatment of autoimmune disease), however, patients may receive steroids for stable CNS metastases as described in exclusion criterion 1
  • Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
  • Ventricular ejection fraction (Ef) =\< 55%
  • Baseline QTc > 470 msec or previous history of QT prolongation while taking other medications
  • Patients who received more than two lines of prior therapy for metastatic disease, neoadjuvant or post-op adjuvant therapy is not considered one line of therapy as long as there was > 6 months of disease-free interval
  • Pregnant or breast-feeding females
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    STA-9090

    Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Drug: STA-9090 · Radiation: Radiologic imaging · Procedure: blood draw

Interventions

  • DrugSTA-9090

    Given IV

  • RadiationRadiologic imaging

    radiologic modalities used to evaluate response to treatment

    Also known as: computerized tomographic (CT) scan, magnetic resonance imaging (MRI), chest x-ray

  • Procedureblood draw

    Venous blood will be drawn from those patients who give consent. Serum will be used to look for biomarkers predictive of response

06

What researchers measure

Primary outcomes

  1. Disease Control Rate

    Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy.

    Time frame: at 8 weeks from the start of therapy

Secondary outcomes

  1. Best Response

    Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.

    Time frame: On-treatment date, to date of disease progression (assessed up to 1 year)

  2. Overall Survival

    Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)

    Time frame: study entry to date of death or last date known alive (assessed over 2.5 yrs)

  3. Number of Patients With Each Worst Grade Toxicity

    Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death

    Time frame: On study date to 30 days following final dose of study drug

Other outcomes

  1. Biomarker Evaluation

    Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.

    Time frame: Pre-treatment and 1 week post-treatment

07

Results

Posted Jul 23, 2014

Participant flow

This study opened in December 2010 and ran to April 2013

Participant flow — Overall Study
MilestoneSTA-9090
Started15
Completed0
Not completed15
Withdrew: Disease progression9
Withdrew: Toxicity2
Withdrew: Withdrew after beginning treatment4

Outcome measures

PrimaryDisease Control Rate

Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy.

Time frame:
at 8 weeks from the start of therapy
Reported as:
Number · percentage of participants
Disease Control Rate
percentage of participantsSTA-9090
Disease Control Rate21
SecondaryBest Response

Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.

Time frame:
On-treatment date, to date of disease progression (assessed up to 1 year)
Reported as:
Number · participants
Best Response
participantsSTA-9090
Complete response0
Partial response0
Stable disease3
Progressive disease8
Not Assessed3
Not Evaluable1
SecondaryOverall Survival

Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)

Time frame:
study entry to date of death or last date known alive (assessed over 2.5 yrs)
Reported as:
Median · days
Overall Survival
daysSTA-9090
Overall Survival125 (45 to 148)
SecondaryNumber of Patients With Each Worst Grade Toxicity

Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death

Time frame:
On study date to 30 days following final dose of study drug
Reported as:
Number · participants
Number of Patients With Each Worst Grade Toxicity
participantsSTA-9090
Patients with worst grade toxicity 10
Patients with worst grade toxicity 25
Patients with worst grade toxicity 38
Patients with worst grade toxicity 40
Patients with worst grade toxicity 50
Other pre-specifiedBiomarker Evaluation

Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.

Time frame:
Pre-treatment and 1 week post-treatment

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
STA-9090—9/14 (64.3%)13/14 (92.9%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventSTA-9090
Abdominal painGastrointestinal disorders3/14
nauseaGastrointestinal disorders3/14
dehydrationMetabolism and nutrition disorders2/14
vomitingGastrointestinal disorders2/14
blood bilirubin increasedHepatobiliary disorders2/14
acute kidney injuryRenal and urinary disorders1/14
alanine aminotransferase increasedInvestigations1/14
alkaline phosphatase increasedInvestigations1/14
ascitesGastrointestinal disorders1/14
aspartate aminotransferase increasedInvestigations1/14
Most frequent other events
Showing 10 of 69
Most frequent other events
EventSTA-9090
abdominal painGastrointestinal disorders9/14
fatigueGeneral disorders9/14
diarrheaGastrointestinal disorders8/14
hyponatremiaMetabolism and nutrition disorders8/14
alkaline phosphatase increasedInvestigations8/14
constipationGastrointestinal disorders7/14
anemiaBlood and lymphatic system disorders7/14
nauseaGastrointestinal disorders6/14
hypokalemiaMetabolism and nutrition disorders6/14
alanine aminotransferase increasedInvestigations6/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)STA-9090
<=18 years0
Between 18 and 65 years9
>=65 years6
Age, Continuous
Age, Continuous(years)STA-9090
Median65 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)STA-9090
Female4
Male11
Region of Enrollment
Region of Enrollment(participants)STA-9090
United States15
08

Study locations

2 sites
  • The Jones Clinic
    Memphis, Tennessee 38138, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232-6838, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01227018
Lead sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Dana Cardin, MD (Assistant Professor of Medicine; Medical Oncologist, Vanderbilt-Ingram Cancer Center) — Principal investigator
First posted
Oct 22, 2010
Start date
Dec 2010
Primary completion
May 2013
Completion
May 2013
Results posted
Jul 23, 2014
Last update
Jul 23, 2014

Study contacts

Dana Cardin, MD
principal investigator · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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