Neoplasms
Conditions
Brief summary
This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary purpose is to assess the safety and tolerability of extended administration of polyethylene glycol (PEG) interferon alfa-2b in participants with solid tumors.
Interventions
Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.
DRUGAcetaminophen
Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Had a response of stable disease or better in PEG interferon alfa-2b base study C/I97-188 (MK-4031-006). * Has a Performance Status of 0 (normal activity), 1 (symptoms, but fully ambulatory), or 2 (symptomatic, but in bed \<50% of the day). * Is enrolled within two weeks of completing their last dose of PEG Interferon alfa-2b on the previous study and has not have received any other therapy during this period.
Exclusion criteria
* Discontinued prior to completing PEG interferon alfa-2b base study C/I97-188 (MK-4031-006). * Is pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | Up to 42 Weeks | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Number of Participants Who Discontinued Treatment Due to an Adverse Event | Up to 40 Weeks | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Objective Response | Up to 40 Weeks | Best Objective Response data were based on World Health Organization (WHO) criteria and included four categories. Complete Response (CR) was the disappearance of all clinically detectable malignant disease. Partial Response (PR) was a decrease of ≥50% of the sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; and a decrease of ≥50% in sum of largest diameters of all unidimensionally measure lesions. Stable Disease (SD) was a \<50% decrease or \<25% increase in sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; or a \<50% decrease or \<25% increase in sum of diameters of all unidimensionally measurable lesions. In addition, no new lesions appeared. Progressive Disease (PD) was a ≥25% increase in size of at least one bidimensionally or unidimensionally measurable lesion or appearance of new lesion. Occurrence of pleural effusion or ascites was also considered PD if substantiated by positive cytology. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEG Interferon Alfa-2b 0.75 mcg/kg OW Participants received PEG interferon alfa-2b 0.75 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. | 1 |
| PEG Interferon Alfa-2b 1.5 mcg/kg OW Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. | 2 |
| PEG Interferon Alfa-2b 3 mcg/kg OW Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. | 2 |
| PEG Interferon Alfa-2b 4.5 mcg/kg OW Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. | 2 |
| PEG Interferon Alfa-2b 6 mcg/kg OW Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. | 11 |
| PEG Interferon Alfa-2b 7.5 mcg/kg OW Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg. | 11 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 3 |
| Overall Study | Disease Progression | 1 | 1 | 1 | 1 | 5 | 6 |
| Overall Study | Not in participant's best interest | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | PEG Interferon Alfa-2b 0.75 mcg/kg OW | PEG Interferon Alfa-2b 1.5 mcg/kg OW | PEG Interferon Alfa-2b 3 mcg/kg OW | PEG Interferon Alfa-2b 4.5 mcg/kg OW | PEG Interferon Alfa-2b 6 mcg/kg OW | PEG Interferon Alfa-2b 7.5 mcg/kg OW | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 62.0 Years | 51.5 Years STANDARD_DEVIATION 14.8 | 52 Years STANDARD_DEVIATION 0 | 59.5 Years STANDARD_DEVIATION 10.6 | 55.4 Years STANDARD_DEVIATION 9.6 | 55.8 Years STANDARD_DEVIATION 10.7 | 55.6 Years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 8 Participants | 10 Participants | 22 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 | 0 / 2 | 0 / 2 | 1 / 11 | 0 / 11 |
| other Total, other adverse events | 1 / 1 | 2 / 2 | 1 / 2 | 2 / 2 | 11 / 11 | 11 / 11 |
| serious Total, serious adverse events | 0 / 1 | 1 / 2 | 0 / 2 | 0 / 2 | 1 / 11 | 3 / 11 |
Outcome results
Primary
Number of Participants Who Discontinued Treatment Due to an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Time frame: Up to 40 Weeks
Population: All enrolled participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PEG Interferon Alfa-2b 0.75 mcg/kg OW | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 Participants |
| PEG Interferon Alfa-2b 1.5 mcg/kg OW | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 Participants |
| PEG Interferon Alfa-2b 3 mcg/kg OW | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 Participants |
| PEG Interferon Alfa-2b 4.5 mcg/kg OW | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 Participants |
| PEG Interferon Alfa-2b 6 mcg/kg OW | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 0 Participants |
| PEG Interferon Alfa-2b 7.5 mcg/kg OW | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 3 Participants |
Primary
Number of Participants Who Experienced an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Time frame: Up to 42 Weeks
Population: All enrolled participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PEG Interferon Alfa-2b 0.75 mcg/kg OW | Number of Participants Who Experienced an Adverse Event | 1 Participants |
| PEG Interferon Alfa-2b 1.5 mcg/kg OW | Number of Participants Who Experienced an Adverse Event | 2 Participants |
| PEG Interferon Alfa-2b 3 mcg/kg OW | Number of Participants Who Experienced an Adverse Event | 1 Participants |
| PEG Interferon Alfa-2b 4.5 mcg/kg OW | Number of Participants Who Experienced an Adverse Event | 2 Participants |
| PEG Interferon Alfa-2b 6 mcg/kg OW | Number of Participants Who Experienced an Adverse Event | 11 Participants |
| PEG Interferon Alfa-2b 7.5 mcg/kg OW | Number of Participants Who Experienced an Adverse Event | 11 Participants |
Secondary
Best Objective Response
Best Objective Response data were based on World Health Organization (WHO) criteria and included four categories. Complete Response (CR) was the disappearance of all clinically detectable malignant disease. Partial Response (PR) was a decrease of ≥50% of the sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; and a decrease of ≥50% in sum of largest diameters of all unidimensionally measure lesions. Stable Disease (SD) was a \<50% decrease or \<25% increase in sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; or a \<50% decrease or \<25% increase in sum of diameters of all unidimensionally measurable lesions. In addition, no new lesions appeared. Progressive Disease (PD) was a ≥25% increase in size of at least one bidimensionally or unidimensionally measurable lesion or appearance of new lesion. Occurrence of pleural effusion or ascites was also considered PD if substantiated by positive cytology.
Time frame: Up to 40 Weeks
Population: All enrolled participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PEG Interferon Alfa-2b 0.75 mcg/kg OW | Best Objective Response | Not Evaluated | 0 Participants |
| PEG Interferon Alfa-2b 0.75 mcg/kg OW | Best Objective Response | Stable Disease (SD) | 1 Participants |
| PEG Interferon Alfa-2b 0.75 mcg/kg OW | Best Objective Response | Complete Response (CR) | 0 Participants |
| PEG Interferon Alfa-2b 0.75 mcg/kg OW | Best Objective Response | Progressive Disease (PD) | 0 Participants |
| PEG Interferon Alfa-2b 0.75 mcg/kg OW | Best Objective Response | Partial Response (PR) | 0 Participants |
| PEG Interferon Alfa-2b 1.5 mcg/kg OW | Best Objective Response | Not Evaluated | 0 Participants |
| PEG Interferon Alfa-2b 1.5 mcg/kg OW | Best Objective Response | Partial Response (PR) | 0 Participants |
| PEG Interferon Alfa-2b 1.5 mcg/kg OW | Best Objective Response | Complete Response (CR) | 0 Participants |
| PEG Interferon Alfa-2b 1.5 mcg/kg OW | Best Objective Response | Stable Disease (SD) | 2 Participants |
| PEG Interferon Alfa-2b 1.5 mcg/kg OW | Best Objective Response | Progressive Disease (PD) | 0 Participants |
| PEG Interferon Alfa-2b 3 mcg/kg OW | Best Objective Response | Stable Disease (SD) | 0 Participants |
| PEG Interferon Alfa-2b 3 mcg/kg OW | Best Objective Response | Complete Response (CR) | 1 Participants |
| PEG Interferon Alfa-2b 3 mcg/kg OW | Best Objective Response | Not Evaluated | 1 Participants |
| PEG Interferon Alfa-2b 3 mcg/kg OW | Best Objective Response | Progressive Disease (PD) | 0 Participants |
| PEG Interferon Alfa-2b 3 mcg/kg OW | Best Objective Response | Partial Response (PR) | 0 Participants |
| PEG Interferon Alfa-2b 4.5 mcg/kg OW | Best Objective Response | Stable Disease (SD) | 0 Participants |
| PEG Interferon Alfa-2b 4.5 mcg/kg OW | Best Objective Response | Complete Response (CR) | 0 Participants |
| PEG Interferon Alfa-2b 4.5 mcg/kg OW | Best Objective Response | Partial Response (PR) | 1 Participants |
| PEG Interferon Alfa-2b 4.5 mcg/kg OW | Best Objective Response | Progressive Disease (PD) | 1 Participants |
| PEG Interferon Alfa-2b 4.5 mcg/kg OW | Best Objective Response | Not Evaluated | 0 Participants |
| PEG Interferon Alfa-2b 6 mcg/kg OW | Best Objective Response | Progressive Disease (PD) | 1 Participants |
| PEG Interferon Alfa-2b 6 mcg/kg OW | Best Objective Response | Complete Response (CR) | 3 Participants |
| PEG Interferon Alfa-2b 6 mcg/kg OW | Best Objective Response | Not Evaluated | 1 Participants |
| PEG Interferon Alfa-2b 6 mcg/kg OW | Best Objective Response | Partial Response (PR) | 0 Participants |
| PEG Interferon Alfa-2b 6 mcg/kg OW | Best Objective Response | Stable Disease (SD) | 6 Participants |
| PEG Interferon Alfa-2b 7.5 mcg/kg OW | Best Objective Response | Complete Response (CR) | 0 Participants |
| PEG Interferon Alfa-2b 7.5 mcg/kg OW | Best Objective Response | Progressive Disease (PD) | 2 Participants |
| PEG Interferon Alfa-2b 7.5 mcg/kg OW | Best Objective Response | Partial Response (PR) | 4 Participants |
| PEG Interferon Alfa-2b 7.5 mcg/kg OW | Best Objective Response | Not Evaluated | 1 Participants |
| PEG Interferon Alfa-2b 7.5 mcg/kg OW | Best Objective Response | Stable Disease (SD) | 4 Participants |