PTC299 in Treating Patients With HIV-Related Kaposi Sarcoma
This study has been terminated.
(Drug supply unavailable.)
Sponsor:
AIDS Malignancy Clinical Trials Consortium
Collaborators:
PTC Therapeutics
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00686842
First received: May 29, 2008
Last updated: June 19, 2012
Last verified: June 2012
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Results First Received: January 30, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Kaposi's Sarcoma |
| Interventions: |
Drug: VEGF inhibitor PTC299 Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Procedure: biopsy |
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 | |
|---|---|
| VEGF Inhibitor PTC299 | Single arm study - all subjects received PTC299 |
Participant Flow: Overall Study
| VEGF Inhibitor PTC299 | |
|---|---|
| STARTED | 17 |
| COMPLETED | 17 |
| NOT COMPLETED | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| VEGF Inhibitor PTC299 | Single arm study - all subjects received PTC299 |
Baseline Measures
| VEGF Inhibitor PTC299 | |
|---|---|
|
Number of Participants
[units: participants] |
17 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
44.7 ± 6.5 |
|
Gender
[units: participants] |
|
| Female | 0 |
| Male | 17 |
|
Region of Enrollment
[units: participants] |
|
| United States | 17 |
Outcome Measures
| 1. Primary: | Safety and Toxicity of Anti-VEGF Small Molecule PTC299 [ Time Frame: All study visits ] |
| 2. Primary: | Maximum Tolerated Dose [ Time Frame: After each group of 3 subjects completes cycle 1 of treatment ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
Yes
| 3. Primary: | Response to Treatment [ Time Frame: After each 28-day cycle of treatment and at discontinuation of therapy ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 4. Secondary: | Pharmacokinetics [ Time Frame: Days 1, 15, 28, 57 ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 5. Secondary: | Effects of Study Drug on Serum and Plasma VEGF, VEGFR, and Cytokine Profiles [ Time Frame: On the first day of every 28-day cycle of treatment, Day 15, and treatment discontinuation ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 6. Secondary: | Effects of Study Drug on HIV and KSHV Viral Loads [ Time Frame: Screening, end of cycle 1, end of every third cycle thereafter, and treatment discontinuation ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 7. Secondary: | Effects of Study Drug on T-lymphocyte Subsets (i.e., CD4 and CD8) [ Time Frame: Screening, day 29, every 3 cycles thereafter, and at treatment discontinuation ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 8. Secondary: | Effects of Study Drug on VEGF, VEGFR-2 and -3, Phospho-Akt, p53, and HIF-1α Expression and Tumor Cell Proliferation, as Measured by Ki-67 Staining, in Tumor Biopsy Samples [ Time Frame: Screening and day 28 ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 9. Secondary: | Effects of Study Drug on Viral Gene Expression and Cellular Gene Transcription, as Measured by Real-time Quantitative PCR-based Profiling, in Tumor Biopsy Samples [ Time Frame: Screening and day 28 ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
Serious Adverse Events Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| VEGF Inhibitor PTC299 | Single arm study - all subjects received PTC299 |
Other Adverse Events
| VEGF Inhibitor PTC299 | |
|---|---|
| Total, other (not including serious) adverse events | |
| # participants affected / at risk | 17/17 |
| Blood and lymphatic system disorders | |
| Anemia | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Neutrophil count decreases | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Gastrointestinal disorders | |
| Abdominal pain | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Constipation | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Diarrhea | |
| # participants affected / at risk | 4/17 (23.53%) |
| # events | 5 |
| Nausea | |
| # participants affected / at risk | 7/17 (41.18%) |
| # events | 10 |
| Vomiting | |
| # participants affected / at risk | 3/17 (17.65%) |
| # events | 5 |
| General disorders | |
| Acidosis | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Edema face | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Edema limbs | |
| # participants affected / at risk | 3/17 (17.65%) |
| # events | 3 |
| Fatigue | |
| # participants affected / at risk | 5/17 (29.41%) |
| # events | 6 |
| Immune system disorders | |
| Arthralgia | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Infections and infestations | |
| Cholesterol high | |
| # participants affected / at risk | 4/17 (23.53%) |
| # events | 6 |
| Skin infection | |
| # participants affected / at risk | 3/17 (17.65%) |
| # events | 4 |
| Investigations | |
| Blood bilirubin increased | |
| # participants affected / at risk | 3/17 (17.65%) |
| # events | 3 |
| Creatinine increased | |
| # participants affected / at risk | 3/17 (17.65%) |
| # events | 3 |
| Metabolism and nutrition disorders | |
| alanine aminotransferase increases | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 4 |
| Hyperglycemia | |
| # participants affected / at risk | 5/17 (29.41%) |
| # events | 8 |
| Hypertriglyceridemia | |
| # participants affected / at risk | 5/17 (29.41%) |
| # events | 6 |
| Hypoalbuminemia | |
| # participants affected / at risk | 3/17 (17.65%) |
| # events | 4 |
| Hypocalcemia | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 5 |
| Hyponatremia | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Hypophosphatemia | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 3 |
| Musculoskeletal and connective tissue disorders | |
| Pain | |
| # participants affected / at risk | 5/17 (29.41%) |
| # events | 6 |
| Nervous system disorders | |
| Headache | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Peripheral sensory neuropathy | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Renal and urinary disorders | |
| Proteinuria | |
| # participants affected / at risk | 3/17 (17.65%) |
| # events | 4 |
| Respiratory, thoracic and mediastinal disorders | |
| Cough | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Dyspnea | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Skin and subcutaneous tissue disorders | |
| alopecia | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
| Skin and subcutaneous tissue disorder | |
| # participants affected / at risk | 2/17 (11.76%) |
| # events | 2 |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
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. |
Results Point of Contact:
Name/Title: Susan Krown, MD, Protocol Chair
Organization: AMC
phone: 301-251-1161
e-mail: amcpm@emmes.com
Organization: AMC
phone: 301-251-1161
e-mail: amcpm@emmes.com
No publications provided
| Responsible Party: | AIDS Malignancy Clinical Trials Consortium |
| ClinicalTrials.gov Identifier: | NCT00686842 History of Changes |
| Other Study ID Numbers: | CDR0000596565, U01CA121947, AMC-059, PTC299-ONC-005-KS |
| Study First Received: | May 29, 2008 |
| Results First Received: | January 30, 2012 |
| Last Updated: | June 19, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |