NCT01059643 · REGISTRY CONDITION SEARCH

A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2019-09-18

The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

→

outcome · POSTED

Progression Free Survival (PFS)

→

outcome · POSTED

Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

→

outcome · POSTED

Tumor Marker Values as Relevant to Specific Tumor Types at Baseline

→

outcome · POSTED

Change in Tumor Size at Smallest Size (Best Response)

→

outcome · POSTED

Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307

→

outcome · POSTED

Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355

→

outcome · POSTED

Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal junction), or squamous cell cancer of the head and neck * Have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines (except prostate cancer participants) * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Are willing to follow study procedures for the duration of the study * Are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment Exclusion Criteria: * Have a serious preexisting medical condition that would preclude participation in the study * Are pregnant or lactating * Have received treatment within 28 days of first dose of LY2523355 with a drug that has not received regulatory approval for any indication * Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases * Have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy * Have QTc interval greater than 470 millisecond (msec) or intraventricular conduction delay (IVCD) with QRS greater than 120 msec on screening electrocardiogram (ECG) * Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral (A, B, C) hepatitis * Participants with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: LY2523355
Drug: pegfilgrastim
label
LY2523355
type
EXPERIMENTAL

interventions

arm Group Labels
LY2523355
description
Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer patients). Additional cycles administered based on patient response assessment.
name
LY2523355
type
DRUG
arm Group Labels
LY2523355
description
6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer patients). Additional cycles of LY2523355 administered based on patient response assessment.
name
pegfilgrastim
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 103
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

measure
Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up
time Frame
End of study treatment up to 30-days post-study treatment discontinuation

primary Outcomes

description
The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
measure
Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
time Frame
Baseline until progressive disease up to 36 weeks post-baseline

secondary Outcomes

description
PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.
measure
Progression Free Survival (PFS)
time Frame
Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment
description
Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.
measure
Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
time Frame
Baseline until progressive disease up to 36 weeks post-baseline
description
The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done).
measure
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
time Frame
Baseline
description
The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100.
measure
Change in Tumor Size at Smallest Size (Best Response)
time Frame
Baseline until cycle with maximum change from baseline up to 36 weeks
description
Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle).
measure
Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307
time Frame
Day 3 of Cycle 1 (21-day cycle)
description
Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level.
measure
Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355
time Frame
Day 1 and Day 3 of Cycle 1 (21-day cycle)

Full study description

brief Summary: The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-0e6edc4d68b43d1aee4f
requested nct id
NCT01059643
primary nct id
NCT01059643
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
payload sha256
f7ab862fc9c4a3514422fe191ace019e4d0d91809a0a4bdd0ffd5c51e6dc5023
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-0e6edc4d68b43d1aee4f
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT01059643
occurrences
context exact
NCT01059643
end
11
exact text
NCT01059643
start
0
offset unit
unicode_code_points
query cond
Small Intestine Cancer
query disease state id
ds-small-intestine-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
source file sha256
69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
source json pointer
/studies/15/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
54b451c36e74969b7a220425a01d4324f9d9628d9fd7b82e5fae009dfdefd3a9
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice