Trial Outcomes & Findings for Genasense, Carboplatin, Paclitaxel (GCP) Combination in Uveal Melanoma (NCT NCT01200342)
NCT ID: NCT01200342
Last Updated: 2016-02-11
Results Overview
Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): \>30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): \>20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Following two 3-week cycles
Results posted on
2016-02-11
Participant Flow
Recruitment Period: December 6, 2010 to November 05, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.
Study was terminated early due to decision by drug sponsor to no longer manufacture investigational drug.
Participant milestones
| Measure |
Genasense + Paclitaxel + Carboplatin
Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m\^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration \[AUC)\]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Genasense + Paclitaxel + Carboplatin
Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m\^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration \[AUC)\]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
|
|---|---|
|
Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Genasense, Carboplatin, Paclitaxel (GCP) Combination in Uveal Melanoma
Baseline characteristics by cohort
| Measure |
Genasense + Paclitaxel + Carboplatin
n=7 Participants
Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m\^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration \[AUC)\]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following two 3-week cyclesPopulation: The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions. Due to inadequate enrollment of study participants, no statistical analyses were able to be performed.
Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): \>30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): \>20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s
Outcome measures
| Measure |
Genasense + Paclitaxel + Carboplatin
n=7 Participants
Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m\^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration \[AUC)\]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
|
|---|---|
|
Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Following two 3-week cyclesPopulation: The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions.
Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): \>30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): \>20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s
Outcome measures
| Measure |
Genasense + Paclitaxel + Carboplatin
n=7 Participants
Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m\^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration \[AUC)\]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
|
|---|---|
|
Number of Participants With Response
Complete Response (CR)
|
0 Participants
|
|
Number of Participants With Response
Partial Response (PR)
|
0 Participants
|
|
Number of Participants With Response
Progressive Disease (PD)
|
1 Participants
|
|
Number of Participants With Response
Stable Disease (SD)
|
6 Participants
|
Adverse Events
Genasense + Paclitaxel + Carboplatin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Genasense + Paclitaxel + Carboplatin
n=7 participants at risk
Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m\^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration \[AUC)\]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Alopecia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • Number of events 10 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Psychiatric disorders
Anorexia
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Aspartate aminotransferase increased
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Eye disorders
Blurred vision
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Chills
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Psychiatric disorders
Confusion
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Gastrointestinal disorders
Constipation
|
71.4%
5/7 • Number of events 6 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Cough
|
28.6%
2/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Renal and urinary disorders
Creatinine increased
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Number of events 10 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Ear and labyrinth disorders
Dizziness
|
57.1%
4/7 • Number of events 6 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Dry mouth
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
2/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Musculoskeletal and connective tissue disorders
Edema limbs
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Eye disorders
Eye disorders
|
14.3%
1/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Fatigue
|
85.7%
6/7 • Number of events 12 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Infections and infestations
Febrile neutropenia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Infections and infestations
Fever
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Nervous system disorders
Gait disturbance
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
28.6%
2/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Nervous system disorders
Hallucinations
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Hot flashes
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Endocrine disorders
Hyperglycemia
|
57.1%
4/7 • Number of events 6 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Renal and urinary disorders
Hyperuricemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
42.9%
3/7 • Number of events 6 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Cardiac disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Infections and infestations
Infections and infestations
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Immune system disorders
Lymphocyte count decreased
|
71.4%
5/7 • Number of events 8 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Infections and infestations
Mucositis oral
|
28.6%
2/7 • Number of events 5 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Nausea
|
85.7%
6/7 • Number of events 13 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Immune system disorders
Neutrophil count decreased
|
57.1%
4/7 • Number of events 12 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Musculoskeletal and connective tissue disorders
Peripheral sensory neuropathy
|
100.0%
7/7 • Number of events 9 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
85.7%
6/7 • Number of events 12 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Infections and infestations
Pruritus
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.9%
3/7 • Number of events 5 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Infections and infestations
Skin infection
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Cardiac disorders
Syncope
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Infections and infestations
Urinary tract infection
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Vascular disorders
Vascular disorders
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Vomiting
|
85.7%
6/7 • Number of events 10 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
General disorders
Weight loss
|
28.6%
2/7 • Number of events 3 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
|
Immune system disorders
White blood cell decreased
|
57.1%
4/7 • Number of events 8 • Adverse events were collected from the day of initial treatment with study drug until thirty (30) days after the last treatment.
Collection Period: April 01, 2011 to September 06, 2013.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place