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Phase 2 Completed N=125 Randomized Treatment

A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer

Source: ClinicalTrials.gov NCT00913835 ↗
Enrolled (actual)
125
Serious AEs
42.4%
Results posted
Apr 2017
Primary outcomePrimary: Progression-Free Survival (PFS) — 18.1; 17.3 weeks — p=0.8049

Summary

The purpose of this study is to determine if participants with platinum-refractory or platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal Doxorubicin alone.

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-Free Survival (PFS)
18.1; 17.3 0.8049
SECONDARY
Overall Survival (OS)
72.3; 70.6 0.6346
SECONDARY
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
12.9; 16.4 0.6190
SECONDARY
Median Duration of Response
39.1; 16.9
SECONDARY
Number of Participants With Adverse Events (AEs) and Who Died
27; 23; 14; 62; 60; 27
SECONDARY
Percentage of Participants With Anti-Olaratumab Antibodies
1.8; 0
SECONDARY
PFS of Participants Who Received Olaratumab After Liposomal Doxorubicin Monotherapy (Descriptive Statistics for Safety and Efficacy for Participants Who Continue on Olaratumab Monotherapy Following Disease Progression on Liposomal Doxorubicin Monotherapy)
7.7
SECONDARY
Area Under the Curve (AUC) of Olaratumab
SECONDARY
Maximum Concentration (Cmax) of Olaratumab
SECONDARY
Half-life (t1/2) of Olaratumab
SECONDARY
Clearance (CL) of Olaratumab
SECONDARY
Apparent Volume of Distribution (Vss) of Olaratumab
SECONDARY
PFS for Participants Who Had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association Between PDGFRα Tumor Expression and PFS)
21.0; 17.3; 32.7; 24.0

Eligibility Criteria

Inclusion Criteria

  • The participant has histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer, or ovarian clear cell carcinoma
  • The participant must have at least one of the following: a platinum-free interval of ≤12 months after the final dose of primary or subsequent platinum-based therapy (platinum-resistant), progression during primary or subsequent platinum-based therapy (platinum-refractory), or persistent radiographic disease after primary or subsequent platinum-based therapy (platinum-refractory)
  • The participant has a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction (LVEF) ≥50%, within 21 days prior to randomization
  • The participant has at least one unidimensionally measurable target lesion [≥20 millimeters (mm) with conventional techniques, or ≥10 mm by spiral computed tomography (CT) or magnetic resonance imaging (MRI)], as defined by Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST v1.0) guidelines. Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • The participant has recovered to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to ≤Grade 2). The exceptions for such effects are allowed lab values of ≤Grade 2 specified elsewhere in these inclusion criteria
  • The participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1 at study entry
  • The participant has the ability to understand and the willingness to sign a written informed consent
  • The participant has adequate hematological functions [absolute neutrophil count (ANC) ≥1200 cells/microliter (cells/μL), hemoglobin ≥9 grams/deciliter (g/dL), and platelets ≥100,000 cells/μL]
  • The participant has adequate hepatic function as defined by total bilirubin ≤1.5 × the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 × the ULN (or ≤5 × the ULN in the presence of known liver metastases)
  • The participant has adequate renal function as defined by serum creatinine ≤1.5 × the institutional ULN. If creatinine is above the ULN, the participant's creatinine clearance is ≥60 milliliters/minute (mL/min)
  • The participant has urinary protein ≤1+ on dipstick or routine urinalysis; if urine dipstick or routine analysis is ≥2+, a 24-hour urine for protein must demonstrate <1000 milligrams (mg) of protein to allow participation
  • The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤1.5 and a partial thromboplastin time (PTT) ≤5seconds above ULN. Participants on anticoagulation must be on a stable dose of anticoagulant with a therapeutic INR and no active bleeding within 14 days prior to randomization, or on low molecular weight heparin AND have no pathological condition carrying a high risk of bleeding. Mild elevations of PTT of up to 1.5 × the ULN are acceptable, provided that, in the opinion of the investigator, they are related to ongoing use of coumarins [for example (e.g.), warfarin]
  • The participant has a pre-study echocardiogram or MUGA scan with an actual LVEF ≥50%, within 21 days prior to randomization
  • Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization and for the duration of study participation

Exclusion Criteria

  • The participant has brain metastases or leptomeningeal disease
  • The participant received more than one biologic and/or mo
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00913835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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