A Study in Advanced Cancer | NCT01226485

NCT01226485

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
I4J-MC-HHBB	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Taladegib	Experimental	Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle. Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors. Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).	Drug: Taladegib

Name	Type	Description	Arm Group Labels	Other Names
Taladegib	Drug	Administered IV	Taladegib	LY2940680

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recommended Phase 2 Dose: Maximum Tolerated Dose	Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest tested dose that had <33% probability of causing a DLT in Cycle 1 of Part A.	Time to First Dose to the End of Cycle 1 of Part A (Up To 28 Days)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])	Pharmacokinetics (PK): 1.Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])	Cycle 1, Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 hour(h), Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10,11, 12 h

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy.
Have the presence of measurable or nonmeasurable disease
Have adequate organ function, including:
- Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until 5 days after the erythrocyte transfusion.
- Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the liver has tumor involvement AST and ALT equaling less than or equal to 5 times ULN are acceptable.
- Renal: Serum creatinine less than or equal to 1.5 times ULN.
Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued previous treatments for cancer and recovered from the acute effects of therapy (for example, at least 42 days for mitomycin-C or nitrosoureas, 28 days for other chemotherapy and biologics. At the discretion of the investigator, hormone refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy and breast cancer patients who are stable on antiestrogen therapy (for example, an aromatase inhibitor) may continue treatment

Exclusion Criteria:

Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
Have serious preexisting medical conditions
Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
Have known current hematologic malignancies or acute or chronic leukemia
Have a known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis (screening is not required)
Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
Have QTc interval of >500 msec on screening electrocardiogram
Patients who have previously received treatment with LY2940680

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Scottsdale	Arizona	85260

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Study completers are participants who received at least one dose of study drug and were evaluated for safety. Part B of the study was not implemented as the estimated half-life was considered long enough for once a day (QD) dosing.

Arm/Group Information

ID	Title	Description
FG000	Part A: Cohort 1	Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.
FG001	Part A: Cohort 2	Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle.
FG002	Part A: Cohort 3	Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle.
FG003	Part A: Cohort 4	Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle.
FG004	Part A: Cohort 5	Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.
FG005	Part C	Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors.
FG006	Part D	Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC).

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0003 subjects FG0016 subjects FG0023 subjects FG0036 subjects FG0047 subjects FG00519 subjects FG00640 subjects
Received at Least One Dose of Drug		FG0003 subjects FG0016 subjects FG0023 subjects FG0036 subjects FG004
COMPLETED		FG0003 subjects FG0016 subjects FG0023 subjects FG0036 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Part A: Cohort 1	Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.
BG001	Part A: Cohort 2	Part A Cohort 2 : 100 mg taladegib administered orally QD on a 28-day cycle.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Recommended Phase 2 Dose: Maximum Tolerated Dose

Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest tested dose that had <33% probability of causing a DLT in Cycle 1 of Part A.

Part A participants who received at least one dose of study drug.

Posted

Number

milligrams (mg)

Time to First Dose to the End of Cycle 1 of Part A (Up To 28 Days)

ID	Title	Description
OG000	All Part A Participants	Part A: Cohort 1 Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A: Cohort 2 Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle. Part A: Cohort 3 Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A: Cohort 4 Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A: Cohort 5 Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Cohort 1	Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Eli Lilly and Company	800-545-5979		ClinicalTrials.gov@lilly.com

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D009369	Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

ID	Term
C581399	LY2940680

Masking Info

EG0000 events0 affected3 at risk

EG0010 events0 affected6 at risk

EG0020 events0 affected3 at risk

EG0030 events0 affected6 at risk

EG0040 events0 affected7 at risk

EG0050 events0 affected19 at risk

EG0061 events1 affected40 at risk

EG0000 events0 affected3 at risk

EG0012 events1 affected6 at risk

EG0020 events0 affected3 at risk

EG0032 events2 affected6 at risk

EG0040 events0 affected7 at risk

EG0050 events0 affected19 at risk

EG0065 events5 affected40 at risk

OG004NA± NAFor n=2, individual values 62.6 and 168 were reported.

OG004NA± NAFor n=3, the minimum=4.85,median=5.94 and maximum=8.23 were collected.

OG0044.08(0.88 to 8.00)

OG004NA± NAn=2, individual values 413 and 465 were reported.

OG004NA± NAFor n=3, minimum= 7.02,median=20.38 and maximum=21.96 were reported.

OG0048.00(5.82 to 10.17)