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Completed

NCT Number: NCT02632448

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have an estimated life expectancy of greater than or equal to (≥)12 weeks
  • Have adequate organ function
  • Have received 1-4 prior systemic therapies for locally advanced or metastatic disease
  • Agree to use medically approved contraceptives during the study and for 3 months following the last study treatment
  • All females must have a negative serum pregnancy test result, and females of child-bearing potential must have a negative urine pregnancy test result, prior to the first study treatment
  • Have tumor lesions considered measurable by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Must be, in the judgment of the investigator, an appropriate candidate for experimental therapy, and no standard therapy would confer clinical benefit

For Part A

  • Must have evidence of cancer (solid tumors, excluding glioblastoma and primary brain tumor) that is advanced or metastatic
  • For the Metabolism Phenotype Arm in Part A, participants must have a Cytochrome P450 (CYP2D6) poor metabolizer phenotype

For Part B

  • Have advanced or metastatic colorectal cancer, triple negative breast cancer (per American Society of Clinical Oncology-College of American Pathology guidelines), epithelial ovarian cancer, endometrial, soft tissue sarcoma, pancreatic cancer
  • For TNBC:
  • Recurrent/refractory Triple Negative Breast Cancer (TNBC) defined as any beast cancer that expresses <1% estrogen receptor (ER) and <1% progesterone receptor (PR) and is Her2 negative
  • For Colorectal (CRC):
  • Must have histologically confirmed advanced or metastatic colorectal cancer
  • For Ovarian Cancer:
  • Must have histologically confirmed advanced or metastatic epithelial ovarian cancer
  • Must be eligible to receive Gemzar (GEM) and not refractory to GEM/carboplatin
  • Must have the ability to tolerate GEM
  • May have received GEM as previous therapy
  • For Endometrial cancer:
  • Must have histologically confirmed endometrial cancer that is metastatic or locally advanced
  • Must have failed at least 1 prior chemotherapy
  • For STS:
  • Must have histologically confirmed STS that is metastatic or locally advanced
  • Patients with gastrointestinal stromal tumors (GIST) must have failed a KIT inhibitor
  • Must have failed at least 1 prior chemotherapy
  • For Pancreatic Cancer:
  • Must have histologically confirmed pancreatic cancer that is metastatic or locally advanced
  • Must have failed at least 1 prior chemotherapy regimen
  • For Part C
  • Participants with high grade serous ovarian cancer (HGSOC) will be screened for specific genetic signatures

Exclusion criteria

  • Have received treatment with an investigational drug which has not received regulatory approval within 21 days of first study treatment
  • Have symptomatic central nervous system (CNS) metastasis
  • Females who are pregnant or nursing
  • Have known positive test results of human immunodeficiency virus, or have chronic active hepatitis A, B or C
  • Have a corrected QT interval (QTcB) greater than (>) 470 milliseconds (msec) (female) or >450 msec (male), or a history of congenital long QT syndrome
  • Have had a bone marrow transplant
  • Have participated in this study, or are currently enrolled in another clinical study of an investigational medicinal product
  • Have had radiation therapy to >25% of bone marrow
  • For Part B
  • Have a history of another active cancer within the past year, except cervical cancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of the skin, or another in situ carcinoma that is considered cured

Treatment and study plan

LY2880070

Drug

Capsules

Gemcitabine

Drug

50 to 600 milligrams per square meter of body surface area (mg/m2)

Other names: Gemzar

Primary outcomes

  1. Maximum Tolerated Dose(s)

    Time frame: Baseline through Cycle 1 (Estimated up to 21 days)

Secondary outcomes

  1. Number of dose limiting toxicities (DLTs)

    Time frame: Baseline through Cycle 1 (Estimated up to 21 days)

  2. Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24)

    Time frame: Baseline to 24-hours post dose (up to Day 20 in Cycle 1)

  3. Peak plasma concentration (Cmax)

    Time frame: Baseline to 24 hours post-dose (up to Day 20 in Cycle 1)

  4. Time to reach maximum plasma concentration (tmax)

    Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)

  5. Change from baseline in white blood cell count

    Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)

  6. Change from baseline in neutrophil count

    Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)

  7. Change from baseline in lymphocyte count

    Time frame: Baseline to 24 hours post dose (up to Day 20 in Cycle 1)

  8. Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1)

    Time frame: Baseline to study completion (estimated up to 4 years)

  9. Duration of objective response

    Time frame: Baseline to study completion (estimated up to 4 years)

  10. Best response

    Time frame: Baseline to study completion (estimated up to 4 years)

  11. Progression free survival

    Time frame: Baseline to study completion (estimated up to 4 years)

  12. Overall survival

    Time frame: Baseline up to 1 year

Sponsors and collaborators

Lead sponsor

Esperas Pharma Inc.

Other

Registry information

Official study title

A Phase 1b/2a Three-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2015
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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