Trial Outcomes & Findings for Personalized Targeted Inhibitors Treatment in Renal Cell Cancer (NCT NCT02560012)
NCT ID: NCT02560012
Last Updated: 2018-10-12
Results Overview
The PFS is defined as the time elapsed between treatment initiation and tumor progression or death from any cause, with censoring of patients who are lost to follow-up. Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): " At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
From date of enrollment until the date of first documented progression, date of death from any cause, or date that the study was stopped, whichever came first, an average of 16 months
Results posted on
2018-10-12
Participant Flow
One enrolled patient's tumor did not have a genomic profile completed as next-generation sequencing was not done. Both proteomics and genomics assessments were required so patient was excluded.
Participant milestones
| Measure |
Personalized Therapy
Participants will receive one of four first-line therapy agents based on their tumor's profile. First-line agents are sunitinib, temsirolimus, sorafenib, or pazopanib. These are all routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Upon disease progression, participant's tumor will be biopsied again to create another tumor profile. The second-line agents are everolimus or axitinib. Both of these are routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Sunitinib: One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off
Temsirolimus: 25 mg by an IV infusion over 30-60 minutes, once a week
Sorafenib: 400 mg (2 tablets) orally twice daily without food
Pazopanib: 800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal
Everolimus: 10 mg orally once daily with or without food
Axitinib: 5 mg orally twice
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Personalized Therapy
Participants will receive one of four first-line therapy agents based on their tumor's profile. First-line agents are sunitinib, temsirolimus, sorafenib, or pazopanib. These are all routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Upon disease progression, participant's tumor will be biopsied again to create another tumor profile. The second-line agents are everolimus or axitinib. Both of these are routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Sunitinib: One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off
Temsirolimus: 25 mg by an IV infusion over 30-60 minutes, once a week
Sorafenib: 400 mg (2 tablets) orally twice daily without food
Pazopanib: 800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal
Everolimus: 10 mg orally once daily with or without food
Axitinib: 5 mg orally twice
|
|---|---|
|
Overall Study
Study Terminated
|
2
|
Baseline Characteristics
Personalized Targeted Inhibitors Treatment in Renal Cell Cancer
Baseline characteristics by cohort
| Measure |
Personalized Therapy
n=3 Participants
Participants will receive one of four first-line therapy agents based on their tumor's profile. First-line agents are sunitinib, temsirolimus, sorafenib, or pazopanib. These are all routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Upon disease progression, participant's tumor will be biopsied again to create another tumor profile. The second-line agents are everolimus or axitinib. Both of these are routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Sunitinib: One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off
Temsirolimus: 25 mg by an IV infusion over 30-60 minutes, once a week
Sorafenib: 400 mg (2 tablets) orally twice daily without food
Pazopanib: 800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal
Everolimus: 10 mg orally once daily with or without food
Axitinib: 5 mg orally twice
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
0-Fully active, pre-disease performance
|
3 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
1-No strenuous activity, ambulatory, light work
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
2-Ambulatory, selfcare, unable to work
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
3-Limited selfcare, confined to bed/chair > 50%
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
4-Completely disabled, no selfcare, bed/chair 100%
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG)
5-Dead
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of enrollment until the date of first documented progression, date of death from any cause, or date that the study was stopped, whichever came first, an average of 16 monthsPopulation: All participants who received personalized therapy (sunitinib, temsirolimus, sorafenib, or pazopanib) based on their tumor's profile.
The PFS is defined as the time elapsed between treatment initiation and tumor progression or death from any cause, with censoring of patients who are lost to follow-up. Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): " At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."
Outcome measures
| Measure |
Personalized Therapy
n=3 Participants
Participants will receive one of four first-line therapy agents based on their tumor's profile. First-line agents are sunitinib, temsirolimus, sorafenib, or pazopanib. These are all routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Upon disease progression, participant's tumor will be biopsied again to create another tumor profile. The second-line agents are everolimus or axitinib. Both of these are routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Sunitinib: One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off
Temsirolimus: 25 mg by an IV infusion over 30-60 minutes, once a week
Sorafenib: 400 mg (2 tablets) orally twice daily without food
Pazopanib: 800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal
Everolimus: 10 mg orally once daily with or without food
Axitinib: 5 mg orally twice
|
|---|---|
|
Number of Participants Who Progressed
|
0 Participants
|
Adverse Events
Personalized Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Personalized Therapy
n=3 participants at risk
Participants will receive one of four first-line therapy agents based on their tumor's profile. First-line agents are sunitinib, temsirolimus, sorafenib, or pazopanib. These are all routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Upon disease progression, participant's tumor will be biopsied again to create another tumor profile. The second-line agents are everolimus or axitinib. Both of these are routine drugs for RCC treatment and will be given at their approved doses and dosing schedules.
Sunitinib: One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off
Temsirolimus: 25 mg by an IV infusion over 30-60 minutes, once a week
Sorafenib: 400 mg (2 tablets) orally twice daily without food
Pazopanib: 800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal
Everolimus: 10 mg orally once daily with or without food
Axitinib: 5 mg orally twice
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Immune system disorders
Anaphylaxis
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Infections and infestations
Bronchial infection
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Investigations
Creatinine increased
|
66.7%
2/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 3 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 3 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 3 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
General disorders
Fever
|
66.7%
2/3 • Number of events 3 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
General disorders
Generalized edema
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders-other, black stool
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Infections and infestations
Herpes simplex reactivation
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Vascular disorders
Hotflashes
|
66.7%
2/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 3 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Gastrointestinal disorders
Mucositis oral
|
66.7%
2/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders-other, body aches
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 6 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Infections and infestations
Papulopustular
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
1/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
66.7%
2/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Infections and infestations
Rash pustular
|
33.3%
1/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
66.7%
2/3 • Number of events 3 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
33.3%
1/3 • Number of events 1 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 2 • From the time the participant signs the informed consent until the study was stopped, an average of 16 months
|
Additional Information
Research Manager
The University of Texas Health Science Center, Houston
Phone: 713-500-6919
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place