A Phase 2 interventional study of Pertuzumab in Solid Cancers, sponsored by Genentech, Inc.. Completed. Per ClinicalTrials.gov, last updated 2015-06-11.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if they are continuing to receive clinical benefit.
Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.
Drug: Pertuzumab
Pertuzumab was supplied as a single-use liquid formulation.
Percentage of Participants Who Experienced an Adverse Event
Time frame: Baseline to the end of the study (up to 2 years, 5 months)
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time frame: Baseline to the end of the study (up to 2 years, 5 months)
| Milestone | Pertuzumab |
|---|---|
| Started | 3 |
| Completed | 0 |
| Not completed | 3 |
| Withdrew: Disease progression | 3 |
| percentage of participants | Pertuzumab |
|---|---|
| Percentage of Participants Who Experienced an Adverse Event | 33.3 |
A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
| percentage of participants | Pertuzumab |
|---|---|
| Complete response | 0.0 |
| Partial response | 0.0 |
| Stable disease | 33.3 |
| Progressive disease | 33.3 |
| Unknown | 33.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pertuzumab | — | 0/3 (0%) | 1/3 (33.3%) |
| Event | Pertuzumab |
|---|---|
| EJECTION FRACTION DECREASEDInvestigations | 1/3 |
Safety population: Participants who received at least 1 dose of pertuzumab.
| Age, Categorical(Participants) | Pertuzumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Pertuzumab |
|---|---|
| Female | 3 |
| Male | 0 |
No study locations are listed for this record.
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.