Trial Outcomes & Findings for Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies (NCT NCT01463982)

Last Updated: 2015-04-23

Results Overview

If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

21 participants

Primary outcome timeframe

Cycle 1 (21 days)

Results posted on

2015-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
Overall Study STARTED	3	8	4	6
Overall Study COMPLETED	3	7	2	6
Overall Study NOT COMPLETED	0	1	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
Overall Study Withdrawal by Subject	0	1	1	0
Overall Study Treatment delay over 5 week	0	0	1	0

Baseline Characteristics

Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ n=3 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ n=8 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ n=4 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ n=6 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Total n=21 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 6.5 • n=5 Participants	59.5 years STANDARD_DEVIATION 9.6 • n=7 Participants	63.8 years STANDARD_DEVIATION 11.1 • n=5 Participants	61.8 years STANDARD_DEVIATION 11.5 • n=4 Participants	61.5 years STANDARD_DEVIATION 9.6 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Region of Enrollment Korea, Republic of	3 participants n=5 Participants	8 participants n=7 Participants	4 participants n=5 Participants	6 participants n=4 Participants	21 participants n=21 Participants

PRIMARY outcome

Timeframe: Cycle 1 (21 days)

Outcome measures

Outcome measures
Measure	Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ n=3 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ n=8 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ n=4 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ n=6 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 36.9	50.0 percentage of participants Interval 6.8 to 93.2	0.0 percentage of participants Interval 0.0 to 45.9

SECONDARY outcome

Timeframe: tumor response evaluation can continue to receive the study drug until PD confirmation

by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)\*100. Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)\*100. Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)\*100.

Outcome measures

Outcome measures
Measure	Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ n=3 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ n=7 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ n=2 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ n=6 Participants One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR) Objective Response rate	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 41.0	0.0 percentage of participants Interval 0.0 to 84.2	33.3 percentage of participants Interval 4.3 to 77.7
Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR) Response Rate	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 41.0	0.0 percentage of participants Interval 0.0 to 84.2	33.3 percentage of participants Interval 4.3 to 77.7
Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR) Disease Control Rate	66.7 percentage of participants Interval 9.4 to 99.2	42.9 percentage of participants Interval 9.9 to 81.6	100 percentage of participants Interval 15.8 to 100.0	50.0 percentage of participants Interval 11.8 to 88.2

Adverse Events

Capecitabine 800mg/㎡ + Oratecan 10mg/㎡

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Capecitabine 800mg/㎡ + Oratecan 15mg/㎡

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Capecitabine 800mg/㎡ + Oratecan 20mg/㎡

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ n=3 participants at risk One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ n=8 participants at risk One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ n=4 participants at risk One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.	Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ n=6 participants at risk One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From starting study medication to discontinuation of study medication The patient took study medication until meet withdrawal criteria.	12.5% 1/8 • Number of events 1 • From starting study medication to discontinuation of study medication The patient took study medication until meet withdrawal criteria.	0.00% 0/4 • From starting study medication to discontinuation of study medication The patient took study medication until meet withdrawal criteria.	0.00% 0/6 • From starting study medication to discontinuation of study medication The patient took study medication until meet withdrawal criteria.
Gastrointestinal disorders Enteritis	0.00% 0/3 • From starting study medication to discontinuation of study medication The patient took study medication until meet withdrawal criteria.	0.00% 0/8 • From starting study medication to discontinuation of study medication The patient took study medication until meet withdrawal criteria.	25.0% 1/4 • Number of events 1 • From starting study medication to discontinuation of study medication The patient took study medication until meet withdrawal criteria.	0.00% 0/6 • From starting study medication to discontinuation of study medication The patient took study medication until meet withdrawal criteria.

Other adverse events

Additional Information

Director of clinical research team

HanmiPharma

Phone: 8224109038

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator will complete the report on this study through discussion with Hanmi Pharmaceutical Co., Ltd. after the study is completed. If the report is to be published, prior agreement in writing should be made between the two parties.
Publication restrictions are in place

Restriction type: OTHER