Clinical Trials /

PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer

NCT01899599

Description:

Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian, fallopian tube or primary peritoneal cancer.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
  • Official Title: A Double-blind, Placebo-controlled, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of Maintenance Therapy With PankoMab-GEX™ After Chemotherapy in Patients With Recurrent Epithelial Ovarian Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: GEXMab25201
  • SECONDARY ID: 2013-000931-28
  • NCT ID: NCT01899599

Conditions

  • Ovarian Epithelial Cancer Recurrent
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer

Interventions

DrugSynonymsArms
GatipotuzumabPankoMab-GEXGatipotuzumab
PlaceboPlacebo

Purpose

Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian, fallopian tube or primary peritoneal cancer.

Detailed Description

      The study is to evaluate the efficacy of PankoMab-GEX vs Placebo in maintaining response
      after 2nd to 4th line of chemotherapy in patients with epithelial ovarian or fallopian tube
      or primary peritoneal cancer. Patients must have responded to platinum based chemotherapy in
      a previous line, while the response to the most recent Pt-based chemotherapy must not have
      lasted more than 12 months. In addition the response between most recent 2 lines of
      chemotherapy prior start of study medication must not have lasted more than 12 months.
    

Trial Arms

NameTypeDescriptionInterventions
GatipotuzumabExperimental1700mg, i.v., q3w
  • Gatipotuzumab
PlaceboPlacebo Comparatormatching placebo
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          1. Female patients ≥18 years of age.

          2. Histologically-confirmed, TA-MUC1 positive, recurrent epithelial ovarian or
             fallopian-tube cancer or primary peritoneal cancer with high-grade (grade 2 or 3)
             serous features or a serous component.

          3. Availability of tumor tissue samples (slices or block) for immune-histological
             confirmation of TA-MUC1 status (tissue samples may also be stored for other further
             specified biomarker assessments).

          4. Patients should have received at least 2 lines but not more than 5 lines of
             chemotherapy prior to start of maintenance treatment.

          5. Documented response to or stable disease following the most recent line of
             chemotherapy (any regimen and duration in accordance with local or international
             guidelines or within independent ethics committee [IEC] approved studies) and received
             last dose of said chemotherapy ≤6 weeks prior to randomization (response to prior
             chemotherapy is defined as a partial/complete response according to radiological
             response criteria and/or a confirmed decline in tumor marker CA125 ≥50% from the
             pretreatment value ≥2 × the upper limit of normal [ULN]; stable disease is defined as
             stable disease according to radiological response criteria with a confirmed lack of
             increase in tumor marker CA125 from the pretreatment value for patients who have a
             pretreatment value ≥2 × ULN and no clinical progression). CA125 prior to randomization
             must be below ULN or CA125 levels must not increase >15% within a time frame >7 days
             if above ULN.

          6. Progression-free interval of ≤12 months immediately preceding the chemotherapy to
             which the patient has just responded.

          7. Sensitive or resistant to the most recent platinum-based chemotherapy preceding the
             chemotherapy to which the patient has just responded (sensitive is thereby defined as
             a recurrence of disease >6 to ≤12 months after end of platinum-based chemotherapy and
             resistant is defined as a recurrence of disease ≤6 months after the end of
             platinum-based chemotherapy).

          8. ECOG performance status ≤1.

          9. Recovered from all chemotherapy-related toxicities to grade 1 or grade 0 according to
             the NCI CTCAE version 4.0, with the exception of alopecia (any grade) and peripheral
             neuropathy (≤grade 2).

         10. Adequate bone marrow and hepatic function at Screening:

               -  Hemoglobin ≥9 g/dL

               -  White blood cell count ≥3.0 × 109/L

               -  Absolute neutrophil count ≥1.5 × 109/L

               -  Platelet count ≥100 × 109/L

               -  Aspartate aminotransferase and alanine aminotransferase <3 × ULN (<5 × ULN in
                  case of liver metastases)

               -  Bilirubin <1.5 × ULN (<3 × ULN in case of liver metastases)

               -  Creatinine <1.5 × ULN.

         11. Any patient with childbearing potential (i.e., not surgically sterile or
             postmenopausal for >1 year) must use highly effective contraceptives with a Pearl
             index <1% according to the Note for guidance on non-clinical safety studies for the
             conduct of human clinical trials and marketing authorization for pharmaceuticals
             (CPMP/ICH/286/95) of the European Medicines Agency (EMA) (Note: although pregnancy is
             unlikely to occur in this patient population, any patient with childbearing potential
             will be withdrawn from the study in the event of pregnancy).

         12. Life expectancy >3 months.

         13. Ability and willingness to give written informed consent. -

        Exclusion Criteria:

          1. Refractory to platinum-based chemotherapy (defined as remained progressive or became
             progressive under any previous platinum-based regimen).

          2. Progression-free interval of >12 months after the most recent antecedent
             platinum-based chemotherapy regimen.

          3. Concomitant anti-tumor therapy or immunotherapy.

          4. Treatment with monoclonal antibodies or investigational agents ≤30 days before
             randomization (Note: prior anti-MUC1 therapy is not permitted at any time).

          5. Limited-field radiotherapy ≤30 days before randomization (Note: extensive prior
             radiotherapy during or following the last line of chemotherapy is not permitted;
             radiotherapy prior to the last line of chemotherapy is permitted).

          6. Prior allergic reaction to a monoclonal antibody, grade 3 IRR or any grade 4 reaction
             to a monoclonal antibody.

          7. Known sensitivity to any component of the test product.

          8. Contraindication to the premedications used in this study (paracetamol/acetaminophen,
             H1 and/or H2 receptor antagonists, and steroids).

          9. Clinical evidence of brain metastasis or leptomeningeal involvement.

         10. Patients with second primary cancer, except: adequately treated non-melanoma skin
             cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ
             (DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumors including
             lymphomas (without bone marrow involvement) curatively treated with no evidence of
             disease for ≥ 5 years.

         11. Primary or secondary immune deficiency.

         12. Clinically active infections >grade 2 using NCI CTCAE v 4.0.

         13. Active hepatitis B or C or infection with human immunodeficiency virus (HIV).

         14. Myocardial infarction within 6 months prior to Screening.

         15. Symptomatic congestive heart failure (New York Heart Association grade 3 or 4),
             unstable angina pectoris within 6 months prior to Screening, significant cardiac
             arrhythmia or history of stroke or transient ischemic attack within 1 year prior to
             Screening.

         16. Prior or planned major surgery within 30 days prior to randomization and/or incomplete
             recovery from prior surgery.

         17. Concomitant use of systemic steroids, except for inhaled, topical or nasal application
             within 30 days prior to randomization (Note: steroids used for premedication are
             permitted).

         18. Active drug or alcohol abuse.

         19. Any uncontrolled medical condition that may put the patient at high risk during
             treatment with an investigational drug, including unstable diabetes mellitus, vena
             cava syndrome, or chronic symptomatic respiratory disease.

         20. Pregnancy or lactation.

         21. Legal incompetence, limited legal competence, or detainment in an institution for
             official or legal reasons.

         22. Receipt of any other investigational medicinal product within the last 30 days before
             randomization or any previous PankoMab-GEXTM administration.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival
Time Frame:from baseline till progression of disease or death
Safety Issue:
Description:PFS will be determined by radiographic progression based on modified RECIST 1.1 or death of any cause.

Secondary Outcome Measures

Measure:To assess the safety and tolerability of maintenance therapy with single-agent PankoMab-GEX™ compared to placebo in patients with metastatic or recurrent ovarian or fallopian tube carcinoma or primary peritoneal carcinoma.
Time Frame:3 weekly
Safety Issue:
Description:Safety will be determined on the occurrence of infusion-related reactions (IRR, treatment emergent adverse events (TEAE) and treatment emergent serious adverse events (TESAE.
Measure:Patient reported outcome
Time Frame:every 9 weeks
Safety Issue:
Description:To evaluate the quality of life (QoL) and other health and health-economy related outcomes

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Glycotope GmbH

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