Trial Outcomes & Findings for Maintenance Dovitinib for Colorectal and Pancreas Cancer (NCT NCT01888965)

Results Overview

Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

2 years

Results posted on

2016-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Dovitinib Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.
Overall Study STARTED	9
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Dovitinib Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.
Overall Study Adverse Event	5
Overall Study Lack of Efficacy	4

Baseline Characteristics

Maintenance Dovitinib for Colorectal and Pancreas Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dovitinib n=9 Participants Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	50.9 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Data cannot be summarized in the data table because biomarker analysis did not take place after study closure due to insufficient number of samples to yield significant results related to dovitinib administration. Instead, collected samples are stored in our biobank, as consented by all patients, for future Oncological analyses of importance.

Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.

Time in days from study entry until disease progression or death Disease progression was defined according to RECIST as at least a 20% increase in the sum of the longest diameter of the target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions

Outcome measures

Outcome measures
Measure	Dovitinib n=9 Participants Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.
Progression-free Survival	46 days Interval 13.0 to 287.0

SECONDARY outcome

Timeframe: 2 years

Population: Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.

Percent of subjects who experience grade 3/ 4 adverse events

Outcome measures

Outcome measures
Measure	Dovitinib n=9 Participants Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.
Safety	56 percentage of participants

Adverse Events

Dovitinib

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dovitinib n=9 participants at risk Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.
General disorders Fatigue	11.1% 1/9 • Number of events 1 • 1 year
Gastrointestinal disorders Gastric obstruction	11.1% 1/9 • Number of events 1 • 1 year
Blood and lymphatic system disorders neutropenia	11.1% 1/9 • Number of events 1 • 1 year
Vascular disorders hypertension	11.1% 1/9 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Laryngospasm	11.1% 1/9 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Dovitinib n=9 participants at risk Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.
Gastrointestinal disorders diarrhea	44.4% 4/9 • Number of events 5 • 1 year
Gastrointestinal disorders nausea/vomiting	33.3% 3/9 • Number of events 5 • 1 year
General disorders fatigue	66.7% 6/9 • Number of events 9 • 1 year
Skin and subcutaneous tissue disorders hand-foot syndrome	11.1% 1/9 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders rash	33.3% 3/9 • Number of events 3 • 1 year
Metabolism and nutrition disorders hypertriglycerodemia	33.3% 3/9 • Number of events 4 • 1 year

Additional Information

John L Marshall

Georgetown Lombardi Comprehensive Cancer Center

Phone: 202 444 7064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place