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| Study Type: | Interventional |
|---|---|
| Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Condition: |
Advanced Cancer |
| Intervention: |
Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| First Patient In = 29-Aug-05. Last Patient Last Visit = 03-Dec-07. Multicenter (4 Outpatient Clinics) in US. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
|
Post-group assignment information: For all cohorts doses were administered in repeated 21-day cycles. Determination of the Maximum Tolerated Dose (MTD), by using dose-escalating design and measured by Dose Limiting Toxicity (DLT) is a standard procedure in the development of chemotherapeutic combinations. |
| Description | |
|---|---|
| Cohort A - Vorinostat BID + Pemetrexed + Cisplatin |
Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin |
| Cohort B - Vorinostat QD + Pemetrexed + Cisplatin |
Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin |
| Cohort C - Vorinostat BID + Pemetrexed |
Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed |
| Cohort D - Vorinostat QD + Pemetrexed |
Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed |
| Cohort A - Vorinostat BID + Pemetrexed + Cisplatin | Cohort B - Vorinostat QD + Pemetrexed + Cisplatin | Cohort C - Vorinostat BID + Pemetrexed | Cohort D - Vorinostat QD + Pemetrexed | |
|---|---|---|---|---|
| STARTED | 13 | 9 | 14 | 16 |
| COMPLETED | 3 | 3 | 2 | 3 |
| NOT COMPLETED | 10 | 6 | 12 | 13 |
| Adverse Event | 5 | 4 | 3 | 3 |
| Progressive Disease | 4 | 1 | 9 | 10 |
| Received radiation on new therapy | 1 | 0 | 0 | 0 |
| > 14 day delay in therapy start | 0 | 1 | 0 | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Cohort A - Vorinostat BID + Pemetrexed + Cisplatin |
Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin |
| Cohort B - Vorinostat QD + Pemetrexed + Cisplatin |
Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin |
| Cohort C - Vorinostat BID + Pemetrexed |
Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed |
| Cohort D - Vorinostat QD + Pemetrexed |
Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed |
| Cohort A - Vorinostat BID + Pemetrexed + Cisplatin | Cohort B - Vorinostat QD + Pemetrexed + Cisplatin | Cohort C - Vorinostat BID + Pemetrexed | Cohort D - Vorinostat QD + Pemetrexed | Total | |
|---|---|---|---|---|---|
|
Number of Participants [units: participants] |
13 | 9 | 14 | 16 | 52 |
|
Age [units: years] Mean ( Full Range ) |
60.52 ( 35 to 81 ) |
58.23 ( 31 to 74 ) |
60.09 ( 41 to 78 ) |
63.63 ( 39 to 81 ) |
61 ( 31 to 81 ) |
|
Gender [units: participants] |
|||||
| Female | 4 | 5 | 7 | 8 | 24 |
| Male | 9 | 4 | 7 | 8 | 28 |
|
Race/Ethnicity [units: participants] |
|||||
| Asian | 0 | 0 | 0 | 1 | 1 |
| Black | 0 | 2 | 0 | 1 | 3 |
| European | 0 | 1 | 0 | 0 | 1 |
| Hispanic American | 1 | 0 | 0 | 2 | 3 |
| White | 12 | 6 | 14 | 12 | 44 |
Outcome Measures
| 1. Primary: | Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level [ Cycle 1 (21 days) ] |
| 2. Secondary: | Safety and Tolerability as Measured by the Number of Participants With Disease Progression [ Any time during 8 cycle treatment period through 30 days after. ] |
