Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED)

NCT01170650 | Terminated Phase 3 DMC

• 2 other identifiers: 8109-002EC-FV-06
• Study Type: interventional
• Target: 441
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare progression-free survival (PFS) (based upon investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (EC145+PLD) with that in participants who receive PLD and placebo.

Conditions

Ovarian Cancer

Keywords

cancer; ovarian; platinum-resistant; Phase III; EC145; EC20

Outcome Measures

Primary Outcomes (1)

• Progression-free survival based on investigator assessment using RECIST v1.1.

  Progression is assessed at 6 week intervals through Week 24 and at 8 week intervals thereafter.

  up to 26 months

Secondary Outcomes (2)

• Compare overall survival of participants between treatment arms.

  Approximately 20 months after last patient randomized

• Incidence of Adverse Events, Serious Adverse Events, and Deaths.

  up to 26 months

Study Arms (2)

Arm A

EXPERIMENTAL

EC145 + Pegylated Liposomal Doxorubicin (PLD)

Drug: EC145; Drug: Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®); Drug: EC20

Arm B

ACTIVE COMPARATOR

placebo + Pegylated Liposomal Doxorubicin (PLD)

Drug: Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®); Drug: placebo; Drug: EC20

Interventions

EC145 DRUG

IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle

Arm A

Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®) DRUG

50 mg/m2 (calculated on the basis of ideal body weight) every 4 weeks. Dose reductions permitted for toxicity.

Also known as: Doxil, Caelyx

Arm A; Arm B

placebo DRUG

IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle

Arm B

EC20 DRUG

During the screening period participants will receive a single intravenous administration of EC20 prior to SPECT imaging

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must sign an approved informed consent form (ICF).
• Participants must be ≥ 18 years of age.
• Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
• Participants must have primary or secondary platinum-resistant ovarian cancer.
• Participants must have at least a single (RECIST v1.1-defined) measurable lesion.
• For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy (PLD). NOTE: For participants with a history of CNS metastasis, baseline radiological imaging must include an evaluation of the head.
• Participants must have had prior debulking surgery.
• Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 2 prior systemic cytotoxic regimens.
• Participants are allowed to have received, but are not required to have received, one additional non-cytotoxic antitumor agent (eg, biologic or cytostatic) for the management of ovarian cancer.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Participants must have recovered (to baseline/stabilization) from prior cytotoxic therapy-associated acute toxicities.
• Participants must have adequate organ function including:
• Bone Marrow Reserve:
• Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L prior to treatment. Participants on maintenance doses of granulocyte colony stimulating factor (G-CSF) are eligible.
• Platelets ≥ 100x10\^9/L

You may not qualify if:

• Patients refractory to primary platinum therapy where "refactory" is defined as disease progression within 6 months of first dose of initial platinum-based therapy.
• Diagnosis of "tumor of low-malignant potential".
• Prior exposure to PLD or anthracycline therapy.
• Prior exposure to FR-targeted therapy (eg, EC145, EC0225, EC0489, farletuzumab).
• Prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.
• Prior abdominal or pelvic radiation therapy or radiation therapy to \> 10% of the bone marrow at any time in the past or prior radiation therapy within the past 3 years to the breast/sternum, dermal lesions, head or neck.
• Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis
• Serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure or recent myocardial infarction. Patients who require antifolate therapy for the management of comorbid conditions (e.g., rheumatoid arthritis) will be excluded from the trial.
• Pregnant or nursing.
• Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
• Symptomatic central nervous system (CNS) metastasis.
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Use of low dose corticosteroid therapy (e.g., for nausea prophylaxis) is acceptable; however, concomitant tamoxifen therapy is not. Supportive care measures are allowed.

Sponsors & Collaborators

• Endocyte: lead

Related Links

• Endocyte website

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

EC145; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Binh Nguyen, MD

  Endocyte

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 27, 2010
• Study Start: April 22, 2011
• Primary Completion: May 31, 2015
• Study Completion: September 8, 2015
• Last Updated: September 30, 2021

Record last verified: 2021-09