Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer

NCT00420381 | Completed Phase 2 Results DMC

• 2 other identifiers: 10738H6Q-MC-S025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.

Conditions

Ovarian Cancer; Neoplasms; Carcinoma

Keywords

Recurrent Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival for at Least 6 Months (PFS-6)

  Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

  Baseline through 6 months

• Number of Participants With Adverse Events and Severe Adverse Events

  Data presented are the number of participants who experienced 1 or more adverse events (AEs) (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

  Baseline through end of study (Up to 45 months)

Secondary Outcomes (4)

• Duration of Progression-Free Survival

  Baseline to disease progression (Up to 38 months)

• Prognostic Factors: Platinum Sensitivity

  Baseline

• Prognostic Factors: Performance Status

  Baseline

• Overall Survival

  Baseline through end of study (Up to 45 months)

Study Arms (1)

A

EXPERIMENTAL

Drug: enzastaurin

Interventions

enzastaurin DRUG

1125 mg loading dose then 500 mg, oral, daily, until progressive disease

Also known as: LY317615

A

Eligibility Criteria

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

You may qualify if:

• Participants must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
• All participants must have measurable disease.
• Participants must have at least one "target lesion" to be used to assess response on this protocol.
• Participants must not be eligible for a higher priority GOG protocol, if one exists.
• Participants who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Participants who have received two prior regimens must have a GOG Performance Status of 0 or 1.
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
• Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to registration.
• Participants must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
• Participants must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease.
• Participants of child-bearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception (for example, intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment.

You may not qualify if:

• Participants with previous enzastaurin treatment.
• Participants who have received radiation to more than 25% of marrow-bearing areas
• Participants with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
• Participants who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
• Participants who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs \[EIAEDs\]).
• Participants who are receiving concurrent administration of any other systemic anticancer therapy except for a biphosphonate if patient has bony metastases.
• Participants who have received prior therapy with non-cytotoxic agents (i.e. bevacizumab).
• Participants with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group 215-854-0770

Philadelphia, Pennsylvania, 19103, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms; Carcinoma; Recurrence

Interventions

enzastaurin

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; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Lydia Usha

  Gynecologic Oncology Group

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 11, 2007
• Study Start: January 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2014
• Last Updated: December 19, 2020
• Results First Posted: December 19, 2020

Record last verified: 2020-11

Locations

US (1)