Trial Outcomes & Findings for A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma (NCT NCT00411762)

Last Updated: 2015-03-27

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Up to 100 weeks

Results posted on

2015-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	PHY906 Administration PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m\^2 days 1-7 of a 14-day cycle Capecitabine PHY906
Overall Study STARTED	25
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	PHY906 Administration PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m\^2 days 1-7 of a 14-day cycle Capecitabine PHY906
Overall Study Withdrawal by Subject	5

Baseline Characteristics

A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PHY906 Administration n=25 Participants PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m\^2 days 1-7 of a 14-day cycle
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 100 weeks

Population: 20 subjects received 2 cycles or more and were evaluated for response

Outcome measures

Outcome measures
Measure	PHY906 Administration n=20 Participants PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m\^2 days 1-7 of a 14-day cycle
Median Progression Free Survival	10.1 weeks Interval 0.4 to 54.1

SECONDARY outcome

Timeframe: Up to 100 weeks

Population: 20 subjects received 2 cycles or more and were evaluated for response

Outcome measures

Outcome measures
Measure	PHY906 Administration n=20 Participants PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m\^2 days 1-7 of a 14-day cycle
Median Overall Survival	21.6 weeks Interval 0.4 to 84.1

Adverse Events

PHY906 Administration

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PHY906 Administration n=25 participants at risk PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m\^2 days 1-7 of a 14-day cycle
Blood and lymphatic system disorders Anemia	12.0% 3/25 • Adverse events were collected through the duration of the study (approximately 4 years)
Blood and lymphatic system disorders Neutropenia	12.0% 3/25 • Adverse events were collected through the duration of the study (approximately 4 years)
Blood and lymphatic system disorders Thrombocytopenia	12.0% 3/25 • Adverse events were collected through the duration of the study (approximately 4 years)
Skin and subcutaneous tissue disorders Mucositis	16.0% 4/25 • Adverse events were collected through the duration of the study (approximately 4 years)
Gastrointestinal disorders Anorexia	32.0% 8/25 • Adverse events were collected through the duration of the study (approximately 4 years)
General disorders Dry mouth/taste alternation	8.0% 2/25 • Adverse events were collected through the duration of the study (approximately 4 years)
Gastrointestinal disorders Nausea/vomiting	12.0% 3/25 • Adverse events were collected through the duration of the study (approximately 4 years)
Gastrointestinal disorders Diarrhea	16.0% 4/25 • Adverse events were collected through the duration of the study (approximately 4 years)
Gastrointestinal disorders Constipation	12.0% 3/25 • Adverse events were collected through the duration of the study (approximately 4 years)
General disorders Fatigue	28.0% 7/25 • Adverse events were collected through the duration of the study (approximately 4 years)
General disorders Hand-Foot Syndrome	20.0% 5/25 • Adverse events were collected through the duration of the study (approximately 4 years)
Skin and subcutaneous tissue disorders Hyperpigmentation	12.0% 3/25 • Adverse events were collected through the duration of the study (approximately 4 years)
Hepatobiliary disorders Elevated Liver Function Tests	8.0% 2/25 • Adverse events were collected through the duration of the study (approximately 4 years)
General disorders Electrolytes Imblances	8.0% 2/25 • Adverse events were collected through the duration of the study (approximately 4 years)

Additional Information

Howard Hochster

Yale University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place