Cancer, Lymphoma
Conditions
Keywords
rollover protocol, romidepsin, Gloucester Pharmaceuticals, Celgene Corporation, continuing treatment
Brief summary
This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.
Detailed description
Participants must have previously participated in a Romidepsin study sponsored by Gloucester Pharmaceuticals or Celgene Corporation.
Interventions
DRUGRomidepsin
The participants will generally continue at the same dose, infusion time and frequency used for the last dose of romidepsin given in the preceding romidepsin study. If the participant entered this rollover study in the middle of a cycle, then the cycle number and cycle day will be carried over from the preceding romidepsin study.
Sponsors
Celgene Corporation
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Previously participated in and fulfilled the inclusion and
Exclusion criteria
in one of the romidepsin clinical trials: ROMI-ADVM-001 (NCT01324310), ROMI-ADVM-002 (NCT01324323). Additional studies added at the discretion of the medical monitor of the study 2. Physician believes continued romidepsin treatment is of benefit to participant. 3. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. 4. Able to adhere to the study visit schedule and other protocol requirements. 5. Negative urine or serum pregnancy test for females of child bearing potential; and 6. All females of child bearing potential must use an effective method of contraception (an intrauterine contraceptive device \[IUCD\] or double contraceptive method using condoms and a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male participants should use contraception during the treatment period and for at least 3 months thereafter. Female participants should avoid the use of estrogen-containing contraceptives, since romidepsin may reduce the effectiveness of estrogen-containing contraceptives. An in vitro binding assay determined that romidepsin competes with β-estradiol for binding to estrogen receptors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days | An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
This rollover study was designed to give access to Romidepsin (Romi) for participants in and then discontinued from Romi studies ROMI-ADVM-001 (NCT01324310) and ROMI-ADVM-002 (NCT01324323) who in the opinion of the investigator could have benefited from ongoing therapy with Romi; those from GPI-06-0002 did not rollover as the study did not close.
Pre-assignment details
Participants started at any point during a cycle which corresponded to their previous Romi study, but continued cycle numbering where it left off from their previous participation in a Romi study
Participants by arm
| Arm | Count |
|---|---|
| ROMI 4 Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m\^2 or 14 mg/m\^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m\^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease Progression | 16 |
| Overall Study | Other | 3 |
Baseline characteristics
| Characteristic | ROMI 4 |
|---|---|
| Age, Continuous | 62.3 Years STANDARD_DEVIATION 12.69 |
| Age, Customized ≤ 65 | 10 Participants |
| Age, Customized > 65 | 9 Participants |
| ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status 0 = Fully Active (Most Favorable Activity) | 9 Participants |
| ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status 1 = Restricted activity but ambulatory | 10 Participants |
| ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status 2 = Ambulatory; unable to carry out activities | 0 Participants |
| ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status 3 = Limited Self-Care | 0 Participants |
| ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status 4 = Completely Disabled | 0 Participants |
| Height | 170.4 Centimeters STANDARD_DEVIATION 11.02 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 19 Participants |
| Race/Ethnicity, Customized Other (unspecified) | 1 Participants |
| Race/Ethnicity, Customized White | 15 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 10 Participants |
| Weight | 75.1 Kilograms STANDARD_DEVIATION 20.06 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 19 |
| serious Total, serious adverse events | 6 / 19 |
Outcome results
Primary
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.
Time frame: All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days
Population: Safety Population = Participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 AE related to study drug | 14 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 Adverse Event (AE) | 18 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 NCI CTCAE Grade 3 AE | 11 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 NCI CTCAE Grade 4-5 AE | 0 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 NCI CTCAE Grade 3 AE related to study drug | 6 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 NCI CTCAE Grade 4-5 AE related to study drug | 0 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 Serious Adverse Event (SAE) | 6 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 SAE related to study drug | 1 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 AE leading to discontinuation | 1 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 AE leading to stopping the study drug | 0 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥ 1 AE leading to dose reduction/interruption | 7 Participants |
| ROMI 4 | Summary of Participants With Treatment Emergent Adverse Events (TEAEs) | ≥1 AE dose reduction related to study drug | 4 Participants |