A Phase 2 interventional study of Placebo and Gemcitabine in Ovarian Cancer, Peritoneal Cancer and Fallopian Tube Cancer, sponsored by Genentech, Inc.. Completed at 41 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-10.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.
This study's enrollment of 131 is above the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.
Browse Fallopian Tube Neoplasms studies →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 placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m\^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Drug: Placebo · Drug: Gemcitabine
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m\^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles
Drug: Gemcitabine · Drug: Pertuzumab
Placebo was provided as a single-use formulation for infusion.
Gemcitabine was provided as a solution for infusion.
Also known as: Gemzar
Pertuzumab was provided as a single-use formulation for infusion.
Also known as: rhuMAb 2C4
Progression-free Survival
Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as \>=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.
Time frame: Baseline to the end of the study (up to 1 year)
Percentage of Participants With an Objective Response
An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.
Time frame: Baseline to the end of the study (up to 1 year)
Duration of the Objective Response
Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.
Time frame: Baseline to the end of the study (up to 1 year)
Percentage of Participants Free From Disease Progression at 4 Months
Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Baseline to Month 4
Duration of Survival
Duration of survival was defined as the time from randomization until death from any cause.
Time frame: Baseline to the end of the study (up to 1 year)
| Milestone | Placebo + Gemcitabine | Pertuzumab + Gemcitabine |
|---|---|---|
| Started | 66 | 65 |
| Completed | 1 | 0 |
| Not completed | 65 | 65 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Disease progression | 56 | 53 |
| Withdrew: Adverse event | 2 | 8 |
| Withdrew: Subject's decision | 3 | 1 |
| Withdrew: Physician decision | 2 | 1 |
| Withdrew: Non-compliance | 0 | 1 |
| Withdrew: Other unspecified | 1 | 1 |
Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as \>=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.
| months | Placebo + Gemcitabine | Pertuzumab + Gemcitabine |
|---|---|---|
| Progression-free Survival | 2.6 (1.4 to 3.9) | 2.9 (2.6 to 4.4) |
An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.
| percentage of participants | Placebo + Gemcitabine | Pertuzumab + Gemcitabine |
|---|---|---|
| Percentage of Participants With an Objective Response | 4.6 | 13.8 |
Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.
| months | Placebo + Gemcitabine | Pertuzumab + Gemcitabine |
|---|---|---|
| Duration of the Objective Response | NA (4.1 to NA) | 6.9 (4.1 to 7.4) |
Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
| percentage of participants | Placebo + Gemcitabine | Pertuzumab + Gemcitabine |
|---|---|---|
| Percentage of Participants Free From Disease Progression at 4 Months | 37.3 | 47.6 |
Duration of survival was defined as the time from randomization until death from any cause.
| months | Placebo + Gemcitabine | Pertuzumab + Gemcitabine |
|---|---|---|
| Duration of Survival | 13.1 (10.5 to 15.5) | 13.0 (9.6 to 18.5) |
Collected over All adverse events were collected from the beginning of study treatment until 30 days after discontinuation of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Gemcitabine | — | 40/65 (61.5%) | 65/65 (100%) |
| Pertuzumab + Gemcitabine | — | 23/65 (35.4%) | 65/65 (100%) |
| Event | Placebo + Gemcitabine | Pertuzumab + Gemcitabine |
|---|---|---|
| SMALL INTESTINAL OBSTRUCTIONGastrointestinal disorders | 8/65 | 2/65 |
| PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders | 1/65 | 4/65 |
| VOMITINGGastrointestinal disorders | 3/65 | 1/65 |
| INTESTINAL OBSTRUCTIONGastrointestinal disorders | 3/65 | 0/65 |
| RENAL FAILURE ACUTERenal and urinary disorders | 3/65 | 1/65 |
| DEHYDRATIONMetabolism and nutrition disorders | 3/65 | 1/65 |
| ILEUSGastrointestinal disorders | 2/65 | 1/65 |
| ABDOMINAL PAINGastrointestinal disorders | 0/65 | 2/65 |
| NAUSEAGastrointestinal disorders | 2/65 | 0/65 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 2/65 | 2/65 |
| Event | Placebo + Gemcitabine | Pertuzumab + Gemcitabine |
|---|---|---|
| FATIGUEGeneral disorders | 50/65 | 51/65 |
| NAUSEAGastrointestinal disorders | 47/65 | 49/65 |
| DIARRHOEAGastrointestinal disorders | 39/65 | 44/65 |
| CONSTIPATIONGastrointestinal disorders | 40/65 | 13/65 |
| ANAEMIABlood and lymphatic system disorders | 39/65 | 31/65 |
| VOMITINGGastrointestinal disorders | 33/65 | 32/65 |
| NEUTROPENIABlood and lymphatic system disorders | 29/65 | 32/65 |
| OEDEMA PERIPHERALGeneral disorders | 28/65 | 20/65 |
| BACK PAINMusculoskeletal and connective tissue disorders | 18/65 | 27/65 |
| ABDOMINAL PAINGastrointestinal disorders | 26/65 | 22/65 |
Safety population: All participants who received any amount of study treatment.
| Age, Continuous(years) | Placebo + Gemcitabine | Pertuzumab + Gemcitabine | Total |
|---|---|---|---|
| Mean | 59.7 ± 11.94 | 57.8 ± 10.79 | 58.7 ± 11.38 |
| Sex: Female, Male(Participants) | Placebo + Gemcitabine | Pertuzumab + Gemcitabine | Total |
|---|---|---|---|
| Female | 65 | 65 | 130 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.