Advanced Cancer
Conditions
Brief summary
This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.
Interventions
DRUGvorinostat
All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug * Patient did not withdraw from the base protocol * Patient agrees to practice effective birth control during the study
Exclusion criteria
* Patient is receiving other standard and/or investigational anticancer therapy * Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With a Serious Drug-related Adverse Event (AE) | From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months) | A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose. A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Base Protocol 001 Vorinostat 400 mg daily (QD) | 13 |
| Base Protocol 006 vorinostat 200 mg twice daily (BID) | 1 |
| Base Protocol 008 vorinostat 400 mg QD | 7 |
| Base Protocol 012 400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel | 4 |
| Base Protocol 013 vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week) | 2 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 | 0 | 0 |
| Overall Study | Disease progression | 8 | 1 | 6 | 4 | 2 |
| Overall Study | not specified or withdrew consent | 3 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Base Protocol 001 | Base Protocol 006 | Base Protocol 008 | Base Protocol 012 | Base Protocol 013 | Total |
|---|---|---|---|---|---|---|
| Age, Customized | 13 Participants | 1 Participants | 7 Participants | 4 Participants | 2 Participants | 27 Participants |
| Sex: Female, Male Female | 8 Participants | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 3 Participants | 3 Participants | 0 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 13 | 0 / 1 | 2 / 7 | 0 / 1 | 1 / 1 | 0 / 1 | 0 / 1 | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 4 / 13 | 1 / 1 | 1 / 7 | 0 / 1 | 1 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Percent of Participants With a Serious Drug-related Adverse Event (AE)
A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose. A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug.
Time frame: From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Base Protocol 001 | Percent of Participants With a Serious Drug-related Adverse Event (AE) | 7.7 percent of participants |
| Base Protocol 006 | Percent of Participants With a Serious Drug-related Adverse Event (AE) | 0 percent of participants |
| Base Protocol 008 | Percent of Participants With a Serious Drug-related Adverse Event (AE) | 0 percent of participants |
| Base Protocol 012 | Percent of Participants With a Serious Drug-related Adverse Event (AE) | 0 percent of participants |
| Base Protocol 013 | Percent of Participants With a Serious Drug-related Adverse Event (AE) | 0 percent of participants |