NCT01690468

Brief Summary

The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe and tolerable when given together, and to determine if this combination of drugs can help people with recurrent ovarian cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 ovarian-cancer

Timeline
Completed

Started Sep 2014

Typical duration for phase_1 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

5.3 years

First QC Date

September 19, 2012

Last Update Submit

September 22, 2020

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    To determine the maximum tolerated dose of TCN-PM when combined with carboplatin in a Phase I clinical trial of biomarker-selected women with platinum-resistant, recurrent or persistent epithelial ovarian, fallopian tube and primary peritoneal cancer (OVCA).

    6 months

Secondary Outcomes (3)

  • Overall Response Rate (ORR)

    2 years

  • Progression Free Survival (PFS)

    2 years

  • Duration of Stable Disease (SD)

    2 years

Study Arms (1)

Triciribine & Carboplatin

EXPERIMENTAL

Phase I/II: 25mg/m\^2 Triciribine and Carboplatin AUC 4. Triciribine escalated to 30, 35, 45mg/m\^2 if toxicities are not encountered. Phase II: Recommended phase II dose of triciribine and carboplatin.

Drug: TriciribineDrug: Carboplatin

Interventions

TriciribineDRUG

Triciribine (15, 25, 30, 35, or 45 mg/m\^2) on days 1, 8, 15 every 21 days. To be given as a 60 minute IV infusion.

Also known as: triciribine phosphate monohydrate, TCN, TCN-PM, AKT inhibitor
Triciribine & Carboplatin
CarboplatinDRUG

Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.

Also known as: Paraplatin®, NSC #241240
Triciribine & Carboplatin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Histologically confirmed, measurable or non-measurable, recurrent or persistent, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. By standard Gynecologic Oncology Group (GOG) criteria, platinum-resistant disease is defined by a disease-free interval of less than 6 months following treatment with a platinum-based regimen, or the progression of disease during platinum-based therapy.
  • At least one prior regimen of chemotherapy, with no maximum number of chemotherapy cycles
  • A serum creatinine ≤ 1.5 mg% obtained ≤ 2 weeks prior to entry
  • Adequate hematologic reserve obtained ≤ 2 weeks prior to entry: leukocytes ≥ 3,000 mm\^3; absolute neutrophil count ≥ 1500 mm\^3; platelets ≥ 100,000 mm\^3
  • Adequate hepatocellular function: aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3x upper limit of normal within institutional limits; bilirubin ≤ 1.5 mg/dl
  • Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2
  • Life expectancy of at least 90 days
  • The patient should be off chemotherapy, biologic therapy and radiation for 28 days.
  • Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity Criteria (CTC) version 4

You may not qualify if:

  • Prior TCN-PM therapy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to TCN-PM
  • Patients must be disease-free of prior invasive malignancies for \>2 years with the exception of basal cell or squamous cell carcinoma of the skin.
  • Inability to give informed consent
  • Pregnancy
  • Corrected QT interval (QTc) prolongation \> 450 milliseconds (msec)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

triciribineCarboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Robert Wenham, MD

    H. Lee Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 21, 2012

Study Start

September 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 24, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)