Advanced Solid TumorsPhase 1NCT01284335

A Safety Study in Participants With Advanced Solid Tumors

A Phase 1 study testing Gemcitabine, Docetaxel and Temozolomide in people with Advanced Solid Tumors, run by Eli Lilly and Company at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: Gemcitabine, Docetaxel and Temozolomide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 234 participants
Where: 19 sitesUnited States
Study dates: Jul 2008to May 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants who have histologically confirmed solid malignancy or lymphoma that is unresectable and/or metastatic for which monotherapy with gemcitabine HCl, docetaxel, temozolomide, cisplatin, or erlotinib would otherwise be appropriate
Must have tumor progression after receiving standard/approved chemotherapy or limited treatment options
Must have measurable or nonmeasurable disease
Have given written informed consent prior to any study-specific procedures
Must have adequate hepatic, hematologic and renal function
Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy or other investigational therapy for at least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy. Endocrine therapies for the treatment of prostate cancer may be continued, at the discretion of the investigator. Whole brain radiation must have been completed 90 days before starting study therapy. Participants without evidence of brain metastases who have received prophylactic whole brain irradiation as part of standard of care for small cell lung cancer may be included in the study with a shorter washout period pending approval by the Lilly physician.

Show all 10Show fewer

Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug.
Females with child-bearing potential must have had a negative serum pregnancy test within 7 days prior to the first dose of study drug.
Must have a serum albumin level greater than or equal to 3.0 g/dL (30 g/L).
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Who cannot join

Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in the study
Participants with active central nervous system or brain metastasis at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out brain metastasis. Participants with stable CNS metastasis not requiring steroids may be eligible.
Have a current hematologic malignancy (other than lymphoma)
Participants with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study)
Participants actively receiving warfarin (Coumadin®) therapy

Show all 12Show fewer

Participants who have previously completed or withdrawn from any study investigating LY573636
Participants with a known hypersensitivity to one of the combination drugs cannot be enrolled to the treatment arm which includes that chemotherapeutic combination
Females who are pregnant or breast feeding
Have known positive test results of HIV, hepatitis B, or hepatitis C
Participants receiving amiodarone, quinidine, propofol, or clozapine.
Participants receiving treatment with strong or moderate inhibitors of CYP2C19, including proton-pump inhibitors (PPIs). Esomeprazole or pantoprazole are allowed if not administered 72 hours before or after LY573636 administration.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

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.
Albany, New York, 12206
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.
Austin, Texas, 78731
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.
Birmingham, Alabama, 35233
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.
Dallas, Texas, 75246
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.
Denver, Colorado, 80218
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.
Fayetteville, Arkansas, 72703
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.
Greenville, South Carolina, 29605
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.
Indianapolis, Indiana, 46219
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.
Kettering, Ohio, 45429
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.
Las Vegas, Nevada, 89169
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.
Norfolk, Virginia, 23502
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.
Orlando, Florida, 32806
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.
Park Ridge, Illinois, 60068
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.
Portland, Oregon, 97213
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.
Spokane, Washington, 99218
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.
The Woodlands, Texas, 77380
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.
Tyler, Texas, 75702
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.
Vancouver, Washington, 98684
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.
Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A Phase 1 Multicenter, Dose-escalation Study of LY573636-sodium in Combination With 1) Gemcitabine HCl or 2) Docetaxel or 3) Temozolomide or 4) Cisplatin, or 5) Erlotinib in Patients With Advanced Solid Tumors

The purpose of this study is to determine a safe dose of LY573636 (tasisulam) when used in 5 separate combinations with an approved cancer medication for treating participants with advanced cancer. Data from this study will be reviewed for any side effects or anti-tumor activity that may be associated with the LY573636 combination treatments.

Conditions: Advanced Solid Tumors
Being tested: Gemcitabine, Docetaxel, Temozolomide, Cisplatin, Erlotinib
Keywords: Advanced solid tumors, Unresectable, Metastatic, Limited treatment options, Measurable or nonmeasurable disease
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GemcitabineDrug
Also called LY18011
1000 mg/m2 administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
DocetaxelDrug
60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
TemozolomideDrug
200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
CisplatinDrug
75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
ErlotinibDrug
150 mg administered orally days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
LY573636Drug
Also called Tasisulam, LY573636-sodium
Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.

Study groups in NCT01284335
Study group	Role	What they receive
Gemcitabine plus LY573636	Experimental	Not described Receives: Drug: Gemcitabine; Drug: LY573636
Docetaxel plus LY573636	Experimental	Not described Receives: Drug: Docetaxel; Drug: LY573636
Temozolomide plus LY573636	Experimental	Not described Receives: Drug: Temozolomide; Drug: LY573636
Cisplatin plus LY573636	Experimental	Not described Receives: Drug: Cisplatin; Drug: LY573636
Erlotinib plus LY573636	Experimental	Not described Receives: Drug: Erlotinib; Drug: LY573636

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose-Limiting Toxicities Cycle 1
A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 thrombocytopenia with bleeding, regardless of duration; Grade ≥3 nonhematologic toxicity (excluding nausea/vomiting or diarrhea that can be controlled with medication, and alopecia). Grade 3 electrolyte toxicity (for example, hypokalemia, hypophosphatemia) will not be considered a DLT unless it is considered related to the study drug or combination and does not resolve with standard replacement treatments within 42 days after Cycle 1 Day 1. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.
Measured: Baseline to Cycle 1 (Up to Day 28)

Secondary outcomes (4)

Pharmacokinetic (PK): Concentration Maximum (Cmax)
Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.
Measured: Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.
Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
Best overall tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions.
Measured: Baseline to Study Completion (Up to 2 years)
Number of Participants With a Clinically Significant Effects
Clinically significant effects are reported if a Grade 3 or higher treatment emergent adverse event (TEAE) and observed in ≥10% of participants or a toxicity possibly related to study drug based on Common Terminology Criteria for Adverse Events (CTCAE). A summary of other nonserious AEs and all SAEs, regardless of causality is located in the Reported Adverse Event section.
Measured: Baseline to Study Completion (Up to 2 years)
PK: Area Under the Curve Albumin (AUCalb)
Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.
Measured: Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008May 2016

First posted27 Jan 2011 (estimated)
Study startJul 2008
Primary completionOct 2012
Study completionMay 2016

Why it stopped: Study was terminated due to the termination of tasisulam development.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01284335
Sponsor's protocol ID: 12267
Other IDs: H8K-MC-JZAK
Status last verified: Dec 2018
First submitted: 19 Jan 2011
Last updated: 10 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jotte RM, Von Hoff DD, Braiteh F, Becerra CR, Richards DA, Smith DA, Garbo L, Stephenson J, Conkling PR, Robert-Vizcarrondo F, Chen J, Turner PK, Chow KH, Tai DF, Ilaria R Jr. An innovative, multi-arm, complete phase 1b study of the novel anti-cancer agent tasisulam in patients with advanced solid tumors. Invest New Drugs. 2015 Feb;33(1):148-58. doi: 10.1007/s10637-014-0160-z. Epub 2014 Sep 28.
PubMed 25260842

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Multicenter, Dose-escalation Study of LY573636-sodium in Combination With 1) Gemcitabine HCl or 2) Docetaxel or 3) Temozolomide or 4) Cisplatin, or 5) Erlotinib in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT01284335
Acronym / sponsor ID: 12267
Conditions: Advanced Solid Tumors
Keywords: Advanced solid tumors, Unresectable, Metastatic, Limited treatment options, Measurable or nonmeasurable disease
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated due to the termination of tasisulam development.
Enrolment: 234 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Oct 2012 (actual)
Study completion: May 2016 (actual)
First posted: 27 Jan 2011 (estimated)
Results: Posted 16 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Gemcitabine plus LY573636	Experimental	Drug: Gemcitabine, Drug: LY573636
Docetaxel plus LY573636	Experimental	Drug: Docetaxel, Drug: LY573636
Temozolomide plus LY573636	Experimental	Drug: Temozolomide, Drug: LY573636
Cisplatin plus LY573636	Experimental	Drug: Cisplatin, Drug: LY573636
Erlotinib plus LY573636	Experimental	Drug: Erlotinib, Drug: LY573636

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Participants who have histologically confirmed solid malignancy or lymphoma that is unresectable and/or metastatic for which monotherapy with gemcitabine HCl, docetaxel, temozolomide, cisplatin, or erlotinib would otherwise be appropriate
Must have tumor progression after receiving standard/approved chemotherapy or limited treatment options
Must have measurable or nonmeasurable disease
Have given written informed consent prior to any study-specific procedures
Must have adequate hepatic, hematologic and renal function

Key exclusion criteria (12 listed)

Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication
Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in the study
Participants with active central nervous system or brain metastasis at the time of study entry. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out brain metastasis. Participants with stable CNS metastasis not requiring steroids may be eligible.
Have a current hematologic malignancy (other than lymphoma)
Participants with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GemcitabineAlso: LY180111000 mg/m2 administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	Drug	Gemcitabine plus LY573636
Docetaxel60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	Drug	Docetaxel plus LY573636
Temozolomide200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	Drug	Temozolomide plus LY573636
Cisplatin75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	Drug	Cisplatin plus LY573636
Erlotinib150 mg administered orally days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.	Drug	Erlotinib plus LY573636
LY573636Also: Tasisulam, LY573636-sodiumIndividualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.	Drug	Cisplatin plus LY573636, Docetaxel plus LY573636, Erlotinib plus LY573636, Gemcitabine plus LY573636, Temozolomide plus LY573636

Primary outcome

Number of Participants With Dose-Limiting Toxicities Cycle 1
Time frame: Baseline to Cycle 1 (Up to Day 28)
A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 thrombocytopenia with bleeding, regardless of duration; Grade ≥3 nonhematologic toxicity (excluding nausea/vomiting or diarrhea that can be controlled with medication, and alopecia). Grade 3 electrolyte toxicity (for example, hypokalemia, hypophosphatemia) will not be considered a DLT unless it is considered related to the study drug or combination and does not resolve with standard replacement treatments within 42 days after Cycle 1 Day 1. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.

4 secondary outcomes

Pharmacokinetic (PK): Concentration Maximum (Cmax)
Time frame: Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.
Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
Time frame: Baseline to Study Completion (Up to 2 years)
Number of Participants With a Clinically Significant Effects
Time frame: Baseline to Study Completion (Up to 2 years)
PK: Area Under the Curve Albumin (AUCalb)
Time frame: Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.

Results and safety

Results posted to the registry on 16 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A Tasisulam + Gemcitabine Dose Escalation	25	25
Arm A Tasisulam + Gemcitabine Dose Confirmation	33	33
Arm B* Tasisulam + Docetaxel Dose Escalation	5	5
Arm B1 Tasisulam + Docetaxel Dose Escalation	5	5
Arm B2 Tasisulam + Docetaxel Dose Escalation	24	24
Arm B2 Tasisulam + Docetaxel Dose Confirmation	26	26
Arm C Tasisulam + Temozolomide Dose Escalation	19	19
Arm C Tasisulam + Temozolomide Dose Confirmation	6	6
Arm D* Tasisulam + Cisplatin Dose Escalation	4	4
Arm D Tasisulam + Cisplatin Dose Escalation	14	14
Arm D Tasisulam + Cisplatin Dose Confirmation	45	45
Arm E Tasisulam + Erlotinib Dose Escalation	16	16
Arm E Tasisulam + Erlotinib Dose Confirmation	12	12

Primary outcome: Number of Participants With Dose-Limiting Toxicities Cycle 1

Time frame: Baseline to Cycle 1 (Up to Day 28). Count of participants. Unit: Participants

Measure	Arm A Tasisulam + Gemcitabine Dose Escalation n = 25	Arm A Tasisulam + Gemcitabine Dose Confirmation n = 33	Arm B* Tasisulam + Docetaxel Dose Escalation n = 5	Arm B1 Tasisulam + Docetaxel Dose Escalation n = 5	Arm B2 Tasisulam + Docetaxel Dose Escalation n = 24	Arm B2 Tasisulam + Docetaxel Dose Confirmation n = 26	Arm C Tasisulam + Temozolomide Dose Escalation n = 19	Arm C Tasisulam + Temozolomide Dose Confirmation n = 6	Arm D* Tasisulam + Cisplatin Dose Escalation n = 4	Arm D Tasisulam + Cisplatin Dose Escalation n = 14	Arm D Tasisulam + Cisplatin Dose Confirmation n = 45	Arm E Tasisulam + Erlotinib Dose Escalation n = 16	Arm E Tasisulam + Erlotinib Dose Confirmation n = 12
Value	4	0	4	4	3	0	3	0	0	2	0	1	0

Population analysed: All participants who received at least one dose of study drug Tasisulam in dose escalation phase and experienced a dose-limiting toxicity.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A Tasisulam + Gemcitabine Dose Escalation	9 of 25 (36%)	24 of 25 (96%)	2 of 25
Arm A Tasisulam + Gemcitabine Dose Confirmation	14 of 33 (42.4%)	33 of 33 (100%)	8 of 33
Arm B* Tasisulam + Docetaxel Dose Escalation	1 of 5 (20%)	5 of 5 (100%)	1 of 5
Arm B1 Tasisulam + Docetaxel Dose Escalation	2 of 5 (40%)	5 of 5 (100%)	1 of 5
Arm B2 Tasisulam + Docetaxel Dose Escalation	9 of 24 (37.5%)	24 of 24 (100%)	0 of 24
Arm B2 Tasisulam + Docetaxel Dose Confirmation	12 of 26 (46.2%)	26 of 26 (100%)	4 of 26
Arm C Tasisulam + Temozolomide Dose Escalation	8 of 19 (42.1%)	19 of 19 (100%)	3 of 19
Arm C Tasisulam + Temozolomide Dose Confirmation	4 of 6 (66.7%)	6 of 6 (100%)	3 of 6
Arm D* Tasisulam + Cisplatin Dose Escalation	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Arm D Tasisulam+ Cisplatin Dose Escalation	4 of 14 (28.6%)	14 of 14 (100%)	2 of 14
Arm D Tasisulam+ Cisplatin Dose Confirmation	19 of 45 (42.2%)	43 of 45 (95.6%)	7 of 45
Arm E Tasisulam + Erlotinib Dose Escalation	6 of 16 (37.5%)	16 of 16 (100%)	3 of 16
Arm E Tasisulam + Erlotinib Dose Confirmation	7 of 12 (58.3%)	11 of 12 (91.7%)	3 of 12

Limitations and caveats (from the sponsor): This study was terminated early due to termination of development of the tasisulam compound. All participants were considered to have completed the study upon the completion of one cycle of treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25260842Jotte RM, Von Hoff DD, Braiteh F, Becerra CR, Richards DA, Smith DA, Garbo L, Stephenson J, Conkling PR, Robert-Vizcarrondo F, Chen J, Turner PK, Chow KH, Tai DF, Ilaria R Jr. An innovative, multi-arm, complete phase 1b study of the novel anti-cancer agent tasisulam in patients with advanced solid tumors. Invest New Drugs. 2015 Feb;33(1):148-58. doi: 10.1007/s10637-014-0160-z. Epub 2014 Sep 28.

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First-in-Human, Multicenter, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YL-18319 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
Solid Tumors, Ovarian
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
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Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
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A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 or Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine, Docetaxel and Temozolomide in people with Advanced Solid Tumors, run by Eli Lilly and Company at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-Limiting Toxicities Cycle 1 (time frame: Baseline to Cycle 1 (Up to Day 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01284335, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.