Trial Outcomes & Findings for A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066) (NCT NCT00424775)

NCT ID: NCT00424775

Last Updated: 2015-04-20

Results Overview

Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 3 participants
• Primary outcome timeframe: 25 Days (first cycle)
• Results posted on: 2015-04-20

Participant Flow

Date of first participant in: 26 January 2007. Data of last participant's last visit in study protocol: 7 March 2007. The study was conducted at single center in Japan.

Vorinostat with Carboplatin and Paclitaxel were investigated in participants with chemotherapy-naive non-small cell lung cancer. Enroll 3 participants to dose level 1 of vorinostat and decide whether to enroll additional participants based on the Dose Limited Toxicity (DLT) manifestation. The starting dose of vorinostat was 300 mg once daily.

Participant milestones

Measure	Vorinostat (300 mg) This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.	Vorinostat (400 mg) This group includes data from all participants who are treated with vorinostat 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. However, no participants received vorinostat 400 mg once daily due to early discontinuation of the study based on the dose limited toxicity on vorinostat 300 mg once daily.
Overall Study STARTED	3	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Vorinostat (300 mg) This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.	Vorinostat (400 mg) This group includes data from all participants who are treated with vorinostat 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. However, no participants received vorinostat 400 mg once daily due to early discontinuation of the study based on the dose limited toxicity on vorinostat 300 mg once daily.
Overall Study Adverse Event	2	0
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)

Baseline characteristics by cohort

Measure	Vorinostat (300 mg) n=3 Participants This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
Age, Continuous	64 years STANDARD_DEVIATION 2.0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 25 Days (first cycle)

Population: All participants who received vorinostat 300 mg once daily.

Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.

Outcome measures

Measure	Vorinostat (300 mg) n=3 Participants This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
Number of Participants With a Dose Limited Toxicity at First Cycle	3 Participants

SECONDARY outcome

Timeframe: Day 4

Population: Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.

Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.

Outcome measures

Measure	Vorinostat (300 mg) n=2 Participants This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
Area Under the Curve (AUC(0-24 hr)) at Day 4	9.76 µM hr Interval 6.61 to 12.9

SECONDARY outcome

Timeframe: Day 5

Population: Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.

Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.

Outcome measures

Measure	Vorinostat (300 mg) n=2 Participants This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
Area Under the Curve (AUC(0-24 hr)) at Day 5	6.26 µM hr Interval 5.37 to 7.14

SECONDARY outcome

Timeframe: Day 4

Population: Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.

Maximum Concentration (Cmax) = the maximum plasma concentration of the drug

Outcome measures

Measure	Vorinostat (300 mg) n=2 Participants This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
Maximum Concentration (Cmax) at Day 4	1.54 µM Interval 0.99 to 2.09

SECONDARY outcome

Timeframe: Day 5

Population: Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.

Maximum Concentration (Cmax) = the maximum plasma concentration of the drug

Outcome measures

Measure	Vorinostat (300 mg) n=2 Participants This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
Maximum Concentration (Cmax) at Day 5	1.96 µM Interval 1.6 to 2.32

Adverse Events

Vorinostat (300 mg)

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	Vorinostat (300 mg) n=3 participants at risk This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
Blood and lymphatic system disorders Anaemia	66.7% 2/3
Blood and lymphatic system disorders Leukopenia	66.7% 2/3
Blood and lymphatic system disorders Lymphopenia	66.7% 2/3
Gastrointestinal disorders Diarrhoea	66.7% 2/3
Gastrointestinal disorders Nausea	66.7% 2/3
Gastrointestinal disorders Vomiting	66.7% 2/3
General disorders Fatigue	66.7% 2/3
General disorders Pyrexia	66.7% 2/3
Metabolism and nutrition disorders Anorexia	66.7% 2/3
Investigations Neutrophil count decreased	66.7% 2/3

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER