Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Olaratumab

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Doxorubicin Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).

Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.

Doxorubicin Alone: On Cycle 1, Day 1, participants received doxorubicin 75 mg/m2 IV

Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.

Olaratumab + Doxorubicin:

For Cycle 2, participants received 20 mg of olaratumab on Days 1 and 8 of each 21-day cycle, IV. On Day 1 of Cycle 2, doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

For Cycles 3 - 8, Day 1 and 8, olaratumab 15 mg/kg was administered and on Day 1 doxorubicin 75 mg/m2 was administered IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.

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)

The purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin.

The safety and tolerability of these drugs will be studied. Each participant will complete two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab alone until discontinuation criteria are met.

Screening is required within 21 days prior to first dose.

Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab when given with doxorubicin.

Participants may only enroll in one part.

A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma

An Open-Label Study to Evaluate the Pharmacokinetics of Doxorubicin Following the Concomitant Intravenous Administration of Olaratumab (IMC-3G3) to Patients With Advanced Soft Tissue Sarcoma

PK: AUC (0-tLast) with a measurable concentration. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.

PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.

Tmax times are relative to the start of the approximately 60-minute IV infusion of olaratumab. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.

The formation of anti-drug antibodies (ADA) was assessed using validated ELISAs, following a 4-tier approach. Both the ADA screening assay and the neutralizing antibody assay were validated in accordance with the US Food and Drug Administration (FDA) Guidance for Industry. Participants who had positive samples for treatment emergence due to being \<4-fold difference from baseline or occurred prior to drug exposure are reported.

The percentage of participants with a best overall response achieving CR or PR (ORR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (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; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. The methodology for the confidence interval calculation is the "exact F" method.

Eli Lilly and Company

All participants in the safety population received at least 1 dose of study drug and at least 1 post dose safety assessment.

Part A

Part B

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All participants who received at least one dose of study drug.

Chief Medical Officer

On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV.

Part A Doxorubicin Alone

On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 1, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Part A Doxorubicin + 15 mg/kg Olaratumab

On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin IV

Part B Doxorubicin Alone

On Cycle 2, Day 1, participants received 75 mg/m2 of doxorubicin IV immediately following the completion of the 20 mg/kg of olaratumab infusion.

Part B Doxorubicin + 20 mg/kg Olaratumab

All participants who received at least one dose of study drugs and had evaluable PK data.

Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) Doxorubicin

On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin, IV.

PK: Maximum Concentration (Cmax) Doxorubicin

PK:Time of Maximum Observed Concentration (Tmax) Doxorubicin

Olaratumab Alone Part A

On Cycle 1, Day 1, participants received 75 mg/m2 of doxorubicin IV and then on Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Part A 15 mg/kg Olaratumab + Doxorubicin

On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab, IV

Part B Olaratumab Alone

Part B 20 mg/kg Olaratumab + Doxorubicin

PK: AUC Zero to Time t, Where t is the Last Time Point (0-tLast) Olaratumab

On Cycle 1, Day 10, participants received 15 mg/kg of olaratumab, IV.

Part A Olaratumab Alone

On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab, IV.

PK: Cmax Olaratumab

PK: Tmax Olaratumab

Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.

Part A 15 mg/kg Olaratumab

Olaratumab Alone: On Cycle 1, Day 10, participants received 20 mg/kg of olaratumab IV.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onwards, until discontinuation criteria are met.

Part B 20 mg/kg Olaratumab

All participants who received at least one dose of study drug and had evaluable baseline and post-baseline anti-olaratumab antibodies.

Percentage of Participants With Olaratumab Antibodies

Part A Dox Alone, Then Olaratumab Alone, Then Dox + Olaratumab

Part B Dox Alone, Then Olaratumab Alone, Then Dox + Olaratumab

All participants who received at least one dose of study drug and had a post-baseline lesion response.

Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

Doxorubicin (Dox) Alone: On Cycle 1, Day 1, participants received 75 milligram/square meter (mg/m2) of doxorubicin intravenously (IV).

Olaratumab Alone: On Cycle 1, Day 10, participants received 15 milligram/kilogram (mg/kg) of olaratumab IV.

Olaratumab + Doxorubicin: For Cycles 2 to 8, participants received 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, IV and 75 mg/m2 of doxorubicin IV immediately following the completion of the olaratumab infusion.

Participants continued to receive olaratumab monotherapy (on days 1 and 8 of each cycle) for Cycle 9 onward, until discontinuation criteria are met.

Spots Global Cancer Trial Database for A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma

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