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PU-H71 in Patients With Solid Tumors and Low-Grade Non-Hodgkin's Lymphoma That Have Not Responded to Standard Treatment

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ClinicalTrials.gov Identifier: NCT01581541
Recruitment Status : Terminated (The study closed prematurely due to discontinuation of drug supply.)
First Posted : April 20, 2012
Results First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Solid Tumors
Lymphoma
Intervention: Drug: PU-H71

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PU-H71, 10 mg/m^2 PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 20 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 40 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 60 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 80 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 110 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 150 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 200 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 266 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 354 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days
PU-H71, 470 mg/m^2 PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days

Participant Flow:   Overall Study
    PU-H71, 10 mg/m^2   PU-H71, 20 mg/m^2   PU-H71, 40 mg/m^2   PU-H71, 60 mg/m^2   PU-H71, 80 mg/m^2   PU-H71, 110 mg/m^2   PU-H71, 150 mg/m^2   PU-H71, 200 mg/m^2   PU-H71, 266 mg/m^2   PU-H71, 354 mg/m^2   PU-H71, 470 mg/m^2
STARTED   1   1   1   1   2   3   1   2   1   3   1 
COMPLETED   1   1   1   1   2   3   1   2   1   3   1 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PU-H71 PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days

Baseline Measures
   PU-H71 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Years]
Median (Full Range)
 59 
 (19 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female   7 
Male   10 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   5.9% 
Not Hispanic or Latino      16  94.1% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   5.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      4  23.5% 
White      11  64.7% 
More than one race      0   0.0% 
Unknown or Not Reported      1   5.9% 
Region of Enrollment 
[Units: Participants]
 
United States   17 
Number of Prior Therapies 
[Units: Prior therapies]
Mean (Full Range)
 7 
 (1 to 14) 
Diagnosis 
[Units: Participants]
Count of Participants
 
Malignant Hürthle cell tumor   1 
Rectal adenocarcinoma   1 
Adenocarcinoma, not otherwise specified   6 
Adenoid cystic carcinoma   1 
Invasive poorly differentiated carcinoma   1 
Metastatic adenocarcinoma   1 
Hepatocellular carcinoma   1 
Carcinoid tumor   1 
Squamous cell carcinoma of the esophagus   1 
Synovial sarcoma   2 
Non-small cell lung cancer   1 


  Outcome Measures

1.  Primary:   Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)   [ Time Frame: Cycle 1 (21 days) ]

2.  Primary:   Number of Participants With Adverse Events Possibly, Probably, or Definitely Related to Study Drug   [ Time Frame: 3 years and two months and 11 days ]

3.  Primary:   Maximum Tolerated Dose (MTD) of PU-H71   [ Time Frame: Cycle 1 (21 days) ]

4.  Secondary:   Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)   [ Time Frame: Baseline and every 6 weeks up to 18 weeks ]

5.  Secondary:   Number of Days on Treatment   [ Time Frame: up to 126 days ]

6.  Secondary:   Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. ]

7.  Secondary:   Terminal Half-life (T1/2)   [ Time Frame: Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. ]

8.  Secondary:   Area Under the Concentration-Time Curve From Time 0 to 24 Hours [AUC(0-24)]   [ Time Frame: Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. ]

9.  Secondary:   Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)]   [ Time Frame: Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. ]

10.  Secondary:   Urinary Excretion (%)   [ Time Frame: Every void post-treatment on day 1 of cycle 1 ]

11.  Secondary:   Clearance   [ Time Frame: Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Shivaani Kummar
Organization: Stanford University School of Medicine
phone: 650-724-9084
e-mail: skummar@stanford.edu


Publications:

Responsible Party: Alice Chen, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01581541     History of Changes
Other Study ID Numbers: 110150
11-C-0150
First Submitted: April 19, 2012
First Posted: April 20, 2012
Results First Submitted: July 28, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017