Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma
6 november 2019 uppdaterad av: Celgene
A Phase 2, Multicenter, Open-label, Single Arm, Two-stage Study to Evaluate the Efficacy and Safety of CC-4047 (Pomalidomide) in Patients With Advanced Soft Tissue Sarcomas Who Have Relapsed or Are Refractory to Systemic Anticancer Therapy
The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
7
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Santa Monica, California, Förenta staterna, 90403
- Sarcoma Oncology Center
-
-
Idaho
-
Coeur d'Alene, Idaho, Förenta staterna, 83814
- Kootenai Cancer Center
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna, 68114
- Nebraska Methodist Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Must be > 18 years of age
- Must have histologically confirmed soft tissue sarcoma
- Must have locally recurrent unresectable, or metastatic soft tissue sarcoma, and have failed or relapsed after a minimum of one and a maximum of 3 prior systemic anticancer therapy regimens
- Must have measurable or evaluable disease determined as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Must have documented disease progression (PD) determined as per RECIST criteria within 3 months prior to study enrollment
- Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion Criteria:
- Pregnant or lactating females
- Prior therapy with thalidomide or lenalidomide
- Prior use of experimental/investigational drug therapy < 3 months prior to treatment initiation
- Prior chemotherapy, biologic or immunotherapy < 3 weeks prior to treatment initiation
- Prior radiotherapy < 3 weeks prior to treatment initiation
- Prior major surgery < 3 weeks prior to treatment initiation
- Absolute neutrophil count (ANC) < 1.5 x 109 cells/L
- Platelet count < 100 x 109cells/L
- Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvate transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN) or > 5.0 x ULN in the presence of demonstrable liver metastases
- Known active central nervous system (CNS) metastases
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Pomalidomide
7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
|
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs
Tidsram: AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).
|
An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study.
It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject's health, including laboratory test values, regardless of etiology.
A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.
For more details, please see the Adverse Events section of this record.
|
AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines
Tidsram: Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).
|
Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria.
Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started.
For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.
|
Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Abderrahim Fandi, MD, Celgene
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2008
Primärt slutförande (Faktisk)
1 januari 2009
Avslutad studie (Faktisk)
1 januari 2009
Studieregistreringsdatum
Först inskickad
16 juli 2008
Först inskickad som uppfyllde QC-kriterierna
16 juli 2008
Första postat (Uppskatta)
17 juli 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 november 2019
Senast verifierad
1 november 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CC-4047-STSAR-001
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .